Maintenance Study for Moderately to Severely Active Crohn's Disease
This study is testing an investigational medicine called duvakitug for people with moderately to severely active Crohn's disease. Researchers want to see if duvakitug is effective and safe as a maintenance treatment. You might be able to join if you are between 16 and 80 years old and have already shown a positive response to treatment in a previous study (STARSCAPE-1). The study will measure success by looking at whether participants achieve clinical remission (a significant reduction in symptoms) and endoscopic response (healing of the bowel lining) after 40 weeks. The current status of this study is unclear, and it plans to enroll about 751 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled Phase 3 study involving approximately 751 participants.
- What's involved
- You would receive injections of either duvakitug or a placebo. The study could last up to 286 weeks, including a 40-week main study and a potential 240-week extension, or 46 weeks if you don't join the extension.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have a follow-up visit 45 days after the main study period or after the open-label extension.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
At a glance
Conditions
Where it's being run
35 sites across 17 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40Week 40
Clinical Remission by Crohn's Disease Activity Index (CDAI): CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
- Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40Week 40
The SES-CD is a standardized method for evaluating disease activity. Score ranges from 0 to 56, where higher scores represent more severe disease. Endoscopic Response by SES-CD is a decrease in SES-CD ≥50% from Baseline (or a decrease of at least 2 points for participants with a Baseline score of 4 or more, and isolated ileal disease) based on central reading.
- Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40Week 40
Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.