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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/NCT02574637
Registration number
NCT02574637
Ethics application status
Date submitted
24/09/2015
Date registered
14/10/2015
Date last updated
26/05/2021
Titles & IDs
Public title
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
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Scientific title
A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
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Secondary ID [1]
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2015-000609-38
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Secondary ID [2]
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D5170C00002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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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 - Brazikumab IV Infusion
Treatment: Drugs - Brazikumab SC Injection
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Experimental: Brazikumab High Dose - Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Experimental: Brazikumab High-Medium Dose - Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Experimental: Brazikumab Low-Medium Dose - Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Experimental: Brazikumab Low Dose - Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Treatment: Drugs: Brazikumab IV Infusion
Brazikumab IV infusion as per protocol specified dosing schedule.
Treatment: Drugs: Brazikumab SC Injection
Brazikumab IV infusion as per protocol specified dosing schedule.
Treatment: Drugs: Placebo
Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
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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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Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8
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Assessment method [1]
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CDAI remission was defined as a CDAI score of <150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Percentage of Participants With Loose/Liquid Stool Frequency Response
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Assessment method [1]
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Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, = 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
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Timepoint [1]
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Baseline, Weeks 8, 16 and 28
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Secondary outcome [2]
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Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response
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Assessment method [2]
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CDAI response was defined as a decrease from baseline in the CDAI score of =100. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [2]
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Baseline, Weeks 8, 16 and 28
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Secondary outcome [3]
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Percentage of Participants With CDAI Clinical Remission
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Assessment method [3]
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CDAI clinical remission was defined as a CDAI score of <150. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [3]
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Weeks 16 and 28
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Secondary outcome [4]
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Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response
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Assessment method [4]
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SES-CD response was defined as a decrease from baseline in SES-CD score of = 50%. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
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Timepoint [4]
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Baseline, Weeks 16 and 28
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Secondary outcome [5]
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Percentage of Participants With Loose/Liquid Stool Frequency Remission
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Assessment method [5]
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Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, = 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
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Timepoint [5]
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Baseline, Weeks 8, 16 and 28
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Secondary outcome [6]
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Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission
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Assessment method [6]
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SES-CD remission was defined as a Total SES-CD score of =4 and no subscore >2. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
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Timepoint [6]
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Weeks 16 and 28
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Secondary outcome [7]
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Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission
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Assessment method [7]
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PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.
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Timepoint [7]
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Weeks 8, 16 and 28
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Secondary outcome [8]
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Percentage of Participants With PRO2 Response
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Assessment method [8]
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PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score > 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: = 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count = 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, = 30% reduction in weekly loose/liquid stool count compared to baseline.
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Timepoint [8]
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Baseline, Weeks 8, 16 and 28
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Secondary outcome [9]
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Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy
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Assessment method [9]
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Timepoint [9]
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Weeks 16 and 28
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Secondary outcome [10]
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Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28
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Assessment method [10]
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CDAI modified sustained clinical remission was defined as a CDAI score of <150 at both Weeks 8 and 28. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [10]
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Weeks 8 and 28
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Secondary outcome [11]
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Serum Brazikumab Concentration
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Assessment method [11]
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Timepoint [11]
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Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4
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Secondary outcome [12]
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Number of Participants With Serum Anti-drug Antibodies for Brazikumab
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Assessment method [12]
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Timepoint [12]
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Predose at Weeks 0, 4, 12, 16, 28, 40 and 52
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Secondary outcome [13]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation
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Assessment method [13]
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An AE is any untoward medical occurrence in a patient/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not related to the investigational product. A TEAE is any new AE or worsening of an existing condition after initiation of treatment. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. AE of special interest were infusion/injection-site reactions, hypersensitivity reactions, malignancies, cardiac events like myocardial infarction, stroke/cardiovascular death, ocular AE including cataracts.
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Timepoint [13]
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From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
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Secondary outcome [14]
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Number of Participants With Clinically Significant Laboratory Values
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Assessment method [14]
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Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.
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Timepoint [14]
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From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
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Secondary outcome [15]
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Percentage of Participants With Abdominal Pain Response
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Assessment method [15]
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Abdominal pain response is defined as a = 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.
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Timepoint [15]
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Baseline; Weeks 8, 16 and 28
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Secondary outcome [16]
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Percentage of Participants With Abdominal Pain Remission
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Assessment method [16]
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Abdominal pain remission is defined as no daily score > 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.
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Timepoint [16]
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Weeks 8, 16 and 28
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Eligibility
Key inclusion criteria
- Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for > 3 months prior
to screening
- Men or women age 18 - 80 years at the time of screening
- Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI)
and endoscopic demonstration of inflammation
- Stable dose of medications for Crohn's disease therapy
- Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis
Factor-Alpha Therapy (anti-TNF a) agent
- Effective contraception from screening, and for 36 weeks after the last dose of
investigational product
- No known history of active tuberculosis (TB) & negative assessment for TB/latent TB
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Minimum age
18
Years
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Maximum age
80
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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
- Severe underlying immunosuppression
- Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing
strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel
perforation
- Significant infections at screening; Infected abscess, positive for Clostridium
difficile, recent infectious hospitalization
- Recent treatment with approved or investigational biologic therapy for Crohn's disease
- Recent or planned live attenuated vaccine
- History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the
cervix with apparent cure = 12 months before screening
- Pregnancy/breast feeding
- Drug abuse
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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 administering the treatment/s
The people assessing the outcomes
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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
5/01/2016
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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
29/01/2018
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Sample size
Target
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Arizona
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Colorado
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Florida
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Missouri
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Tennessee
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Texas
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Wisconsin
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Belgium
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Bonheiden
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Belgium
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Leuven
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Haute Garonne
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France
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Ille Et Vilaine
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France
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Loire
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Rennes
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France
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Saint-Priez En Jarez
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France
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Toulouse Cedex 9
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France
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Vandoeuvre-Les-Nancy
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Hessen
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Germany
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Nordrhein Westfalen
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Germany
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Dortmund
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Israel
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Rechovot
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Israel
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Rehovot
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Maastricht
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Rotterdam
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Russian Federation
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St. Petersburg
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Spain
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants
with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor
necrosis factor-alpha (anti-TNFa) therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02574637
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02574637
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