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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02574637
Date of registration: 24/09/2015
Prospective Registration: Yes
Primary sponsor: Allergan
Public title: Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
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
Date of first enrolment: January 5, 2016
Target sample size: 29
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02574637
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Australia Belgium Bulgaria Canada Czech Republic France Germany Hungary
Israel Italy Korea, Republic of Netherlands Poland Russian Federation Spain Turkey
United Kingdom United States
Contacts
Name:     Carl Gommoll, MS
Address: 
Telephone:
Email:
Affiliation:  Allergan
Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Brazikumab IV Infusion
Drug: Placebo
Drug: Brazikumab SC Injection
Primary Outcome(s)
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8 [Time Frame: Week 8]
Secondary Outcome(s)
Percentage of Participants With Loose/Liquid Stool Frequency Remission [Time Frame: Baseline, Weeks 8, 16 and 28]
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission [Time Frame: Weeks 16 and 28]
Percentage of Participants With Loose/Liquid Stool Frequency Response [Time Frame: Baseline, Weeks 8, 16 and 28]
Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission [Time Frame: Weeks 8, 16 and 28]
Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28 [Time Frame: Weeks 8 and 28]
Number of Participants With Clinically Significant Laboratory Values [Time Frame: From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)]
Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy [Time Frame: Weeks 16 and 28]
Percentage of Participants With PRO2 Response [Time Frame: Baseline, Weeks 8, 16 and 28]
Serum Brazikumab Concentration [Time Frame: Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4]
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response [Time Frame: Baseline, Weeks 8, 16 and 28]
Percentage of Participants With Abdominal Pain Response [Time Frame: Baseline; Weeks 8, 16 and 28]
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response [Time Frame: Baseline, Weeks 16 and 28]
Percentage of Participants With Abdominal Pain Remission [Time Frame: Weeks 8, 16 and 28]
Number of Participants With Serum Anti-drug Antibodies for Brazikumab [Time Frame: Predose at Weeks 0, 4, 12, 16, 28, 40 and 52]
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation [Time Frame: From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)]
Percentage of Participants With CDAI Clinical Remission [Time Frame: Weeks 16 and 28]
Secondary ID(s)
D5170C00002
2015-000609-38
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 15/05/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02574637
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