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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 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 618 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03104413
The ClinicalTrials.gov registry entry for NCT03104413 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 618 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo for risankizumab IV is the first listed.
NCT03104413 reports 0 study locations.
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.
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