A 52 Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease

Phase 2

Suspended

Conditions: Health Condition 1: K509- Crohns disease, unspecified

Registration Number: CTRI/2020/02/023533

Lead Sponsor: ASTRAZENECA AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Aged 18 to 80 years, inclusive, at Screening.

2) Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to screening

3) Moderately to severely active Crohns Disease

Exclusion Criteria

1) Participant is unable or unwilling to have endoscopic procedures performed during the study.

2) History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.

3) Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to screening.

4) Participant has known history of drug (including opiates) or alcohol abuse.

5) Currently enrolled in another investigational device or drug study.

6) Participant is pregnant, breastfeeding, or plans to become pregnant during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage 1: Percentage of participants achieving the CDAI remission at Week 12 <br/ ><br> <br/ ><br>Stage 2. Percentage of participants with endoscopic response and clinical remission at Week 52Timepoint: Stage 1. Week 12 <br/ ><br> <br/ ><br>Stage 2. Percentage of participants with endoscopic response and clinical remission at Week 52

Secondary Outcome Measures

Name	Time	Method
Stage 1: Percentage of participants achieving the CDAI remission, CDAI response, endoscopic response, SES-CD total score of 0-2, endoscopic remission, and clinical remission at Week 52Timepoint: Week 52;Stage 1: Percentage of participants achieving the endoscopic response, CDAI response, and clinical remission at Week 12Timepoint: Week 12;Stage 1: Percentage of participants achieving the sustained CDAI remission, CDAI response, endoscopic response, and clinical remission at both Week 12 and Week 52Timepoint: Week 12 and Week 52;Stage 2. Percentage of participants with corticosteriod-free endoscopic remission and clinical remission at Week 52Timepoint: 52 Weeks;Stage 2. Percentage of participants with endoscopic remission and clinical remission at Week 52Timepoint: 52 Weeks;Stage 2. Percentage of participants with endoscopic response and clinical remission at both Weeks 12 and 52Timepoint: Up to 52 Weeks