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NCT03105128 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 931
- Enrollment target
NCT03105128: Completed Phase 3 study, sponsored by AbbVie.
NCT03105128 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 931 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03105128, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 931 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Primary Outcome
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Interventions
- DRUG placebo for risankizumab
- DRUG risankizumab SC
- DRUG risankizumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 931 participants |
| Start Date | 2017-05-10 |
| Est. Completion | 2021-04-14 |
| Phase | Phase 3 |
What the finished NCT03105128 record still lists
NCT03105128 is an interventional study that assigns participants to a tested intervention. The registered 931 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo for risankizumab is the first listed.
NCT03105128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03105128 about?
NCT03105128 is a clinical study titled "A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
What is the current status of trial NCT03105128?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 931 participants. The study started on 2017-05-10. Estimated completion is 2021-04-14.
What interventions are being tested in trial NCT03105128?
The interventions under investigation include: placebo for risankizumab (DRUG), risankizumab SC (DRUG), risankizumab IV (DRUG).
Who is sponsoring clinical trial NCT03105128?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03105128's enrollment target sits among peer trials
931 338th of 2000 higher than 1,663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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