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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02394028
Registration number
NCT02394028
Ethics application status
Date submitted
27/02/2015
Date registered
20/03/2015
Date last updated
16/11/2022
Titles & IDs
Public title
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
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Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
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Secondary ID [1]
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0
2014-003824-36
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Secondary ID [2]
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GA29144
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Universal Trial Number (UTN)
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Trial acronym
BERGAMOT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etrolizumab
Treatment: Drugs - Placebo
Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg - Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg - Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Placebo comparator: Induction Phase - Cohort 1 (Exploratory): Placebo - Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg - Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg - Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg - Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg - Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.
Placebo comparator: Induction Phase - Cohort 3 (Pivotal): Placebo - Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.
Placebo comparator: Maintenance Phase - Placebo Responders: Placebo - Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 will undergo a sham randomization into the Maintenance Phase. Placebo responders from induction will receive blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.
Placebo comparator: Maintenance Phase - Etrolizumab Responders: Placebo - Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.
Experimental: Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg - Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.
Treatment: Drugs: Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Treatment: Drugs: Placebo
Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
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Assessment method [1]
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Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (=)3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
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Timepoint [1]
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Week 14
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Primary outcome [2]
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Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
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Assessment method [2]
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Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (=)3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
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Timepoint [2]
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Week 14
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Primary outcome [3]
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Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
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Assessment method [3]
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Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
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Timepoint [3]
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Week 14
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Primary outcome [4]
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Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
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Assessment method [4]
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Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.
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Timepoint [4]
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Week 14
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Primary outcome [5]
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Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
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Assessment method [5]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Maintenance phase participants were evaluated.
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Timepoint [5]
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Baseline and Week 66
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Primary outcome [6]
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Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
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Assessment method [6]
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Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Maintenance phase participants were evaluated.
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Timepoint [6]
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Week 66
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Secondary outcome [1]
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Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
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Assessment method [1]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
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Timepoint [1]
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Week 6
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Secondary outcome [2]
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Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
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Assessment method [2]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
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Timepoint [2]
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Week 6
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Secondary outcome [3]
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Induction Phase: Cohort 1: Percentage of Participants With SES-CD Score =4 (=2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
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Assessment method [3]
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Endoscopic Remission is defined as SES-CD total score \<=4 (\<=2 for ileal only patients), with no segment having a subcategory score \>1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
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Timepoint [3]
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Week 14
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Secondary outcome [4]
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Induction Phase: Cohort 2 and 3: Percentage of Participants With SES-CD Score =4 (=2 for Ileal Participants), With No Segment Having a Subcategory Score Greater Than (>)1, at Week 14
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Assessment method [4]
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Endoscopic Remission is defined as SES-CD total score \<=4 (\<=2 for ileal only patients), with no segment having a subcategory score \>1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
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Timepoint [4]
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Week 14
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Secondary outcome [5]
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Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
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Assessment method [5]
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CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
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Timepoint [5]
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0
Baseline and Week 14
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Secondary outcome [6]
0
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Induction Phase: Cohort 2 and 3: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
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Assessment method [6]
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CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
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Timepoint [6]
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Baseline and Week 14
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Secondary outcome [7]
0
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Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
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Assessment method [7]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase Cohorts are not included
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Timepoint [7]
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0
Baseline, Weeks 14 and 66
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Secondary outcome [8]
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Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
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Assessment method [8]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.
Induction Phase Cohorts are not included
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Timepoint [8]
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Baseline and Week 66
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Secondary outcome [9]
0
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Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
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Assessment method [9]
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Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score. Induction Phase Cohorts are not included
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Timepoint [9]
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Baseline, Weeks 14 and 66
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Secondary outcome [10]
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Maintenance Phase: Percentage of Participants With SES-CD Score =4 (=2 for Ileal Participants), With No Segment Having a Subcategory Score >1, at Week 66
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Assessment method [10]
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Endoscopic Remission is defined as SES-CD total score \<=4 (\<=2 for ileal only patients), with no segment having a subcategory score \>1. SES-CD = Simple Endoscopic Score for Crohn's Disease. A composite of four assessments, each rated from 0 to 3: size of ulcers, proportion of the surface covered by ulcers, proportion of the surface with any other lesions, and presence of narrowings (stenosis). The SES-CD total score ranges from 0 to 60, a higher score indicates worse disease activity.
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Timepoint [10]
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0
Week 66
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Secondary outcome [11]
0
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Maintenance Phase: Percentage of Participants With Durable Clinical Remission
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Assessment method [11]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at =4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66. Induction Phase Cohorts are not included
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Timepoint [11]
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Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
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Secondary outcome [12]
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Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
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Assessment method [12]
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Clinical remission is defined as SF mean daily score =3 and abdominal pain mean daily score =1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported.
Induction Phase Cohorts are not included
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Timepoint [12]
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0
Baseline and from Week 14 up to Week 66
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Secondary outcome [13]
0
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Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
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Assessment method [13]
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CD-PRO/SS: Crohn's Disease Patient Reported Outcomes Signs and Symptoms. For each item, the score is taken as the average across 4-7 days eDiary data within a 9 day window from visit, else the score is considered missing. The CD-PRO/SS Bowel domain is a total score summed across 3 items and ranges from 0 - 16. The Functional domain score is a total score summed across 3 items and ranges from 0 - 12. A higher CD-PRO/SS score indicates worse quality of life. Participants are included in the analysis if they have both Baseline and at least one post-baseline score available.
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Timepoint [13]
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Baseline and Week 66
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Secondary outcome [14]
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Overall Number of Participants Who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
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Assessment method [14]
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Investigator text for AEs is coded using MedDRA version 24.0. For participants counts, multiple occurrences of AEs in the same category for an individual are counted only once. For event counts, multiple occurrences of AEs in the same category for an individual are counted separately. Severity Grades from 1 to 5.
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Timepoint [14]
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From Baseline up to Week 78
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Secondary outcome [15]
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Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
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Assessment method [15]
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Number of participants who discontinued the study due to the adverse events is reported.
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Timepoint [15]
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From Baseline up to Week 78
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Secondary outcome [16]
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Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
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Assessment method [16]
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Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 are reported. Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = Death. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs are counted only once per participant at the highest (worst) grade. Infections are identified by Primary System Organ Class term 'Infections and Infestations'
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Timepoint [16]
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From Baseline up to Week 78
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Secondary outcome [17]
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Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
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Assessment method [17]
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Investigator text for AEs is coded using MedDRA version 24.0. Infections are identified by primary System Organ Class term 'Infections and Infestations'. The terms 'severe' and 'serious' are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs in the same category for an individual are counted only once
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Timepoint [17]
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From Baseline up to Week 78
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Secondary outcome [18]
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0
Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
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Assessment method [18]
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Investigator test for AEs is coding using MedDRA version 24.0. Injection-Site Reactions are identified by eCRF checkbox for local injection site reactions, and/or primary or secondary HLT Injection Site Reactions. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
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Timepoint [18]
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0
From Baseline up to Week 78
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Secondary outcome [19]
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0
Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
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Assessment method [19]
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0
Investigator text for AEs is coded using MedDRA version 24.0. Multiple occurrences of AEs for an individual are counted only once, under the worst grade reported.
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Timepoint [19]
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0
From Baseline up to Week 78
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Secondary outcome [20]
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Overall Number of Participants Who Develop Malignancies
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Assessment method [20]
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Participants with malignancies are reported. 'Malignancies are identified by SMQ Malignant and unspecified tumors (narrow)
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Timepoint [20]
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From Baseline up to Week 78
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Secondary outcome [21]
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
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Assessment method [21]
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Participants who received at least one dose of study treatment and had at least one baseline or post-baseline ATA result. Induction: treatment groups were pooled across cohorts 1-3. Maintenance: treatment group is stratified by induction dose
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Timepoint [21]
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Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)
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Secondary outcome [22]
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Observed Trough Serum Concentration (Ctrough) of Etrolizumab
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Assessment method [22]
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Serum Etrolizumab Trough Concentration
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Timepoint [22]
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Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66
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Eligibility
Key inclusion criteria
* Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
* Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy
* Use of effective contraception as defined by the protocol
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome
* Planned surgery for CD
* Ileostomy or colostomy
* Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
* Any prior treatment with ustekinumab within 14 weeks prior to randomization
* Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)
* Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary
* Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])
* Any major episode of infection requiring treatment with intravenous antibiotics =8 weeks prior to screening or oral antibiotics =4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary
* Hospitalization (other than for elective reasons) within 4 weeks prior to randomization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/03/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/09/2021
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Sample size
Target
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Accrual to date
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Final
1035
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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0
The Canberra Hospital - Garran
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Recruitment hospital [2]
0
0
Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [3]
0
0
Concord Repatriation General Hospital - Concord
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Recruitment hospital [4]
0
0
Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [5]
0
0
University of the Sunshine Coast - Sippy Downs
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Recruitment hospital [6]
0
0
Mater Adult Hospital - South Brisbane
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Recruitment hospital [7]
0
0
Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [8]
0
0
Flinders Medical Centre - Bedford Park
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Recruitment hospital [9]
0
0
Monash Medical Centre Clayton - Clayton
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Recruitment hospital [10]
0
0
St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [11]
0
0
Footscray Hospital; Gastroenterology - Footscray
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Recruitment hospital [12]
0
0
St Frances Xavier Cabrini Hospital - Malvern
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Recruitment hospital [13]
0
0
Alfred Hospital - Melbourne
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Recruitment hospital [14]
0
0
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
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Recruitment hospital [15]
0
0
Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
0
0
2065 - Garran
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Recruitment postcode(s) [2]
0
0
2200 - Bankstown
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Recruitment postcode(s) [3]
0
0
2139 - Concord
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Recruitment postcode(s) [4]
0
0
4029 - Herston
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Recruitment postcode(s) [5]
0
0
4556 - Sippy Downs
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Recruitment postcode(s) [6]
0
0
4101 - South Brisbane
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Recruitment postcode(s) [7]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [8]
0
0
5042 - Bedford Park
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Recruitment postcode(s) [9]
0
0
3168 - Clayton
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Recruitment postcode(s) [10]
0
0
3065 - Fitzroy
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Recruitment postcode(s) [11]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [12]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [13]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [14]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [15]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Minnesota
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Mississippi
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Wisconsin
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Buenos Aires
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Salzburg
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Wien
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Brussels
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Brussel
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Bruxelles
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Edegem
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Gent
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
DF
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
GO
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
MG
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
PR
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
RJ
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
RS
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
SP
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sofia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Alberta
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
British Columbia
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Manitoba
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Nova Scotia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Quebec
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Saskatchewan
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Osijek
Query!
Country [50]
0
0
Croatia
Query!
State/province [50]
0
0
Pula
Query!
Country [51]
0
0
Croatia
Query!
State/province [51]
0
0
Zagreb
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Brno
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Ceske Budejovice
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Hradec Kralove
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Olomouc
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Ostrava - Poruba
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Praha 7
Query!
Country [58]
0
0
Czechia
Query!
State/province [58]
0
0
Praha
Query!
Country [59]
0
0
Estonia
Query!
State/province [59]
0
0
Tallinn
Query!
Country [60]
0
0
Estonia
Query!
State/province [60]
0
0
Tartu
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Amiens
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Caen
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Clichy cedex
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Lille
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Nantes
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Nice
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Paris
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Pessac
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Pierre-Benite
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Reims
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Rennes cedex 09
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Saint Etienne
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Strasbourg
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Vandoeuvre-les-nancy
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Berlin
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Bochum
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Frankfurt
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Halle
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Hannover
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Koeln
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Mannheim
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Offenburg
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Tuebingen
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Ulm
Query!
Country [85]
0
0
Hungary
Query!
State/province [85]
0
0
Bekescsaba
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Budapest
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Debrecen
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Gyor
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Kistarcsa
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Pecs
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Székesfehérvár
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Afula
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Beer Sheva
Query!
Country [94]
0
0
Israel
Query!
State/province [94]
0
0
Holon
Query!
Country [95]
0
0
Israel
Query!
State/province [95]
0
0
Jerusalem
Query!
Country [96]
0
0
Israel
Query!
State/province [96]
0
0
Nazareth
Query!
Country [97]
0
0
Israel
Query!
State/province [97]
0
0
Petach Tikva
Query!
Country [98]
0
0
Israel
Query!
State/province [98]
0
0
Tel Aviv
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Emilia-Romagna
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Lazio
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Lombardia
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Piemonte
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Toscana
Query!
Country [104]
0
0
Korea, Republic of
Query!
State/province [104]
0
0
Busan
Query!
Country [105]
0
0
Korea, Republic of
Query!
State/province [105]
0
0
Daegu
Query!
Country [106]
0
0
Korea, Republic of
Query!
State/province [106]
0
0
Gyeonggi-do
Query!
Country [107]
0
0
Korea, Republic of
Query!
State/province [107]
0
0
Seongnam-si
Query!
Country [108]
0
0
Korea, Republic of
Query!
State/province [108]
0
0
Seongnam
Query!
Country [109]
0
0
Korea, Republic of
Query!
State/province [109]
0
0
Seoul
Query!
Country [110]
0
0
Korea, Republic of
Query!
State/province [110]
0
0
Wonju-Si
Query!
Country [111]
0
0
Latvia
Query!
State/province [111]
0
0
Riga
Query!
Country [112]
0
0
Lithuania
Query!
State/province [112]
0
0
Kaunas
Query!
Country [113]
0
0
Lithuania
Query!
State/province [113]
0
0
Vilnius
Query!
Country [114]
0
0
Mexico
Query!
State/province [114]
0
0
Mexico CITY (federal District)
Query!
Country [115]
0
0
Mexico
Query!
State/province [115]
0
0
Yucatan
Query!
Country [116]
0
0
Netherlands
Query!
State/province [116]
0
0
Amsterdam
Query!
Country [117]
0
0
Netherlands
Query!
State/province [117]
0
0
Leiden
Query!
Country [118]
0
0
Netherlands
Query!
State/province [118]
0
0
Maastricht
Query!
Country [119]
0
0
Netherlands
Query!
State/province [119]
0
0
Rotterdam
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Sittard-Geleen
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Tilburg
Query!
Country [122]
0
0
New Zealand
Query!
State/province [122]
0
0
Auckland
Query!
Country [123]
0
0
New Zealand
Query!
State/province [123]
0
0
Christchurch
Query!
Country [124]
0
0
New Zealand
Query!
State/province [124]
0
0
Dunedin
Query!
Country [125]
0
0
New Zealand
Query!
State/province [125]
0
0
Hamilton
Query!
Country [126]
0
0
New Zealand
Query!
State/province [126]
0
0
Takapuna
Query!
Country [127]
0
0
New Zealand
Query!
State/province [127]
0
0
Tauranga
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Bialystok
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Bydgoszcz
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Elblag
Query!
Country [131]
0
0
Poland
Query!
State/province [131]
0
0
Kielce
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Ksawerow
Query!
Country [133]
0
0
Poland
Query!
State/province [133]
0
0
Lublin
Query!
Country [134]
0
0
Poland
Query!
State/province [134]
0
0
Nowy Targ
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Rzeszow
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Rzeszów
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Sopot
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Szczecin
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Torun
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Warszawa
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Wroclaw
Query!
Country [142]
0
0
Romania
Query!
State/province [142]
0
0
Bucharest
Query!
Country [143]
0
0
Romania
Query!
State/province [143]
0
0
Bucuresti
Query!
Country [144]
0
0
Romania
Query!
State/province [144]
0
0
Timisoara
Query!
Country [145]
0
0
Russian Federation
Query!
State/province [145]
0
0
Adygeja
Query!
Country [146]
0
0
Russian Federation
Query!
State/province [146]
0
0
Altaj
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Leningrad
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Sankt Petersburg
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Barnaul
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
Irkutsk
Query!
Country [151]
0
0
Russian Federation
Query!
State/province [151]
0
0
Novosibirsk
Query!
Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Omsk
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
Pushkin
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
Rostov-on-Don
Query!
Country [155]
0
0
Russian Federation
Query!
State/province [155]
0
0
St. Petersburg
Query!
Country [156]
0
0
Serbia
Query!
State/province [156]
0
0
Belgrade
Query!
Country [157]
0
0
Serbia
Query!
State/province [157]
0
0
Novi Sad
Query!
Country [158]
0
0
Serbia
Query!
State/province [158]
0
0
Zrenjanin
Query!
Country [159]
0
0
Slovakia
Query!
State/province [159]
0
0
Bratislava
Query!
Country [160]
0
0
Slovakia
Query!
State/province [160]
0
0
Nitra
Query!
Country [161]
0
0
Slovakia
Query!
State/province [161]
0
0
Vranov nad Toplou
Query!
Country [162]
0
0
Slovakia
Query!
State/province [162]
0
0
Šahy
Query!
Country [163]
0
0
South Africa
Query!
State/province [163]
0
0
Cape Town
Query!
Country [164]
0
0
South Africa
Query!
State/province [164]
0
0
Pretoria
Query!
Country [165]
0
0
Spain
Query!
State/province [165]
0
0
Barcelona
Query!
Country [166]
0
0
Spain
Query!
State/province [166]
0
0
Madrid
Query!
Country [167]
0
0
Spain
Query!
State/province [167]
0
0
Cordoba
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
Huelva
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Pontevedra
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
Sevilla
Query!
Country [171]
0
0
Spain
Query!
State/province [171]
0
0
Valencia
Query!
Country [172]
0
0
Spain
Query!
State/province [172]
0
0
Zaragoza
Query!
Country [173]
0
0
Switzerland
Query!
State/province [173]
0
0
Bern
Query!
Country [174]
0
0
Switzerland
Query!
State/province [174]
0
0
Zürich
Query!
Country [175]
0
0
Turkey
Query!
State/province [175]
0
0
Ankara
Query!
Country [176]
0
0
Turkey
Query!
State/province [176]
0
0
Istanbul
Query!
Country [177]
0
0
Turkey
Query!
State/province [177]
0
0
Izmir
Query!
Country [178]
0
0
Turkey
Query!
State/province [178]
0
0
Kocaeli
Query!
Country [179]
0
0
Turkey
Query!
State/province [179]
0
0
Kozyatagi
Query!
Country [180]
0
0
Ukraine
Query!
State/province [180]
0
0
Kharkiv Governorate
Query!
Country [181]
0
0
Ukraine
Query!
State/province [181]
0
0
KIEV Governorate
Query!
Country [182]
0
0
Ukraine
Query!
State/province [182]
0
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Kuban People's Republica
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Tavria Okruha
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Kharkiv
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Kyiv
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Ukraine
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Zaporizhzhia
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United Kingdom
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Belfast
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Cambridge
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Coventry
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Exeter
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Leeds
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Manchester
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Reading
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Southampton
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Wolverhampton
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Funding & Sponsors
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Hoffmann-La Roche
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Summary
Brief summary
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs. The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
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Trial website
https://clinicaltrials.gov/study/NCT02394028
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Trial related presentations / publications
Sandborn WJ, Panes J, Danese S, Sharafali Z, Hassanali A, Jacob-Moffatt R, Eden C, Daperno M, Valentine JF, Laharie D, Baia C, Atreya R, Panaccione R, Rydzewska G, Aguilar H, Vermeire S; BERGAMOT Study Group. Etrolizumab as induction and maintenance therapy in patients with moderately to severely active Crohn's disease (BERGAMOT): a randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):43-55. doi: 10.1016/S2468-1253(22)00303-X. Epub 2022 Oct 12. Dai B, Hackney JA, Ichikawa R, Nguyen A, Elstrott J, Orozco LD, Sun KH, Modrusan Z, Gogineni A, Scherl A, Gubatan J, Habtezion A, Deswal M, Somsouk M, Faubion WA, Chai A, Sharafali Z, Hassanali A, Oh YS, Tole S, McBride J, Keir ME, Yi T. Dual targeting of lymphocyte homing and retention through alpha4beta7 and alphaEbeta7 inhibition in inflammatory bowel disease. Cell Rep Med. 2021 Aug 17;2(8):100381. doi: 10.1016/j.xcrm.2021.100381. eCollection 2021 Aug 17. Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25. Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.
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Contacts
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Hoffmann-La Roche
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/28/NCT02394028/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/28/NCT02394028/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02394028
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