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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
2014-003824-36
Secondary ID [2] 0 0
GA29144
Universal Trial Number (UTN)
Trial acronym
BERGAMOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14
Timepoint [1] 0 0
Week 14
Primary outcome [2] 0 0
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14
Timepoint [2] 0 0
Week 14
Primary outcome [3] 0 0
Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14
Timepoint [3] 0 0
Week 14
Primary outcome [4] 0 0
Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14
Timepoint [4] 0 0
Week 14
Primary outcome [5] 0 0
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66
Timepoint [5] 0 0
Baseline and Week 66
Primary outcome [6] 0 0
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Timepoint [6] 0 0
Week 66
Secondary outcome [1] 0 0
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 6
Timepoint [1] 0 0
Week 6
Secondary outcome [2] 0 0
Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 6
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 14
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Induction Phase: Cohort 1: Change From Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14
Timepoint [5] 0 0
Baseline and Week 14
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline and Week 14
Secondary outcome [7] 0 0
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, Among Those Who Achieved Clinical Remission at Week 14
Timepoint [7] 0 0
Baseline, Weeks 14 and 66
Secondary outcome [8] 0 0
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66, Among Those Who Were Receiving Corticosteroids at Baseline
Timepoint [8] 0 0
Baseline and Week 66
Secondary outcome [9] 0 0
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66 Among Participants Who Achieved Endoscopic Improvement at Week 14
Timepoint [9] 0 0
Baseline, Weeks 14 and 66
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Week 66
Secondary outcome [11] 0 0
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Timepoint [11] 0 0
Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline and from Week 14 up to Week 66
Secondary outcome [13] 0 0
Maintenance Phase: Change From Baseline in CD-PRO/SS Score at Week 66
Timepoint [13] 0 0
Baseline and Week 66
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
From Baseline up to Week 78
Secondary outcome [15] 0 0
Overall Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Timepoint [15] 0 0
From Baseline up to Week 78
Secondary outcome [16] 0 0
Overall Number of Participants Who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0
Timepoint [16] 0 0
From Baseline up to Week 78
Secondary outcome [17] 0 0
Overall Number of Participants Who Experienced at Least One Infection-Related Serious Adverse Event
Timepoint [17] 0 0
From Baseline up to Week 78
Secondary outcome [18] 0 0
Overall Number of Participants Who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0
Timepoint [18] 0 0
From Baseline up to Week 78
Secondary outcome [19] 0 0
Overall Number of Participants Who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0
Timepoint [19] 0 0
From Baseline up to Week 78
Secondary outcome [20] 0 0
Overall Number of Participants Who Develop Malignancies
Timepoint [20] 0 0
From Baseline up to Week 78
Secondary outcome [21] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
Timepoint [21] 0 0
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)
Secondary outcome [22] 0 0
Observed Trough Serum Concentration (Ctrough) of Etrolizumab
Timepoint [22] 0 0
Induction Phase at Weeks 10 and 14, Maintenance Phase at Weeks 16, 24, 28, 32, 44, and 66

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/09/2021
Sample size
Target
Accrual to date
Final
1035
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [6] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [10] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [11] 0 0
Footscray Hospital; Gastroenterology - Footscray
Recruitment hospital [12] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [13] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics - Parkville
Recruitment hospital [15] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - Garran
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3011 - Footscray
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment outside Australia
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Colorado
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Reims
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Bochum
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Halle
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Hannover
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Germany
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Koeln
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Germany
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Mannheim
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Germany
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Offenburg
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Germany
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Tuebingen
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Ulm
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Hungary
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Bekescsaba
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Budapest
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Debrecen
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Gyor
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Kistarcsa
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Pecs
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Székesfehérvár
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Israel
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Afula
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Israel
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Beer Sheva
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Nazareth
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Italy
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Lazio
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Italy
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Piemonte
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Toscana
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Busan
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Daegu
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Gyeonggi-do
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Seongnam
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Seoul
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Leiden
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Maastricht
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02394028
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02394028