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NCT03104413 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 618
- Enrollment target
NCT03104413: Completed Phase 3 study, sponsored by AbbVie.
NCT03104413 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 618 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03104413, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 618 participants
- Enrollment target
Study Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active 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 IV
- DRUG risankizumab SC
- DRUG risankizumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 618 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 3 |
What the finished NCT03104413 record still lists
NCT03104413 is an interventional study that assigns participants to a tested intervention. The registered 618 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo for risankizumab IV is the first listed.
NCT03104413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03104413 about?
NCT03104413 is a clinical study titled "A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment". The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
What is the current status of trial NCT03104413?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 618 participants. The study started on 2017-12-18. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT03104413?
The interventions under investigation include: placebo for risankizumab IV (DRUG), risankizumab SC (DRUG), risankizumab IV (DRUG).
Who is sponsoring clinical trial NCT03104413?
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 NCT03104413's enrollment target sits among peer trials
618 591st of 2000 higher than 1,409 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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