Crohn's Disease is an autoimmune disease that effects the colon causing persistent diarrhea and abdominal cramps. This study is being done to determine if the drug duvakitug can improve symptoms or induce remission in particiapants.
STARSCAPE-1
STARSCAPE-1: A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease
Crohn's disease
All genders
18-80
Recruiting now
Overview
Principal Investigator: Sonia Friedman
Contact Us
Lainey Mullen
Study details
Inclusion Criteria
- Confirmed diagnosis of Crohn's Disease at least 3 months prior
- Previous use of other therapies that showed loss of response or intolerance
- Moderately to severely active Crohn's Disease
Exclusion Criteria
- Diagnosis of Ulcerative colitis
- Complications of Chrohn's Disease including abscess, bowl strictures, fulminant colitis, and others
- Active cancers (excluding basal cell carcinoma, squamous cell carcinoma in situ of the skin, and cervical carcinoma in situ)
Study Requirements
For this study, there will be 5 weeks of screening, 12 weeks of treatment (sub-study 1 or 2), another possible 12 weeks of treatment if enrolled in the extension study (sub-study 3) following sub-study 1 and 2, and then 6 weeks to follow-up. This totals 35 weeks of participation if included in the extension study and 23 weeks if not included. For the sub-study 1 and 2, there will be 8 on-site visits and an additional 7(a total of 15) if participating in the extension study. If eligible for self-administration at home, there may be fewer on-site visits. For sub-study 1 and 2, there will be 3 endoscopies and there will be 1 additional endoscopy for sub-study 3 (4 total). Biopsies will be collected during each endoscopy. Blood collection will be done 6 times for sub-study 1 and 2, and an additional 3 times if participating in sub-study 3. The volume will differ by the specific type.