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NCT03398148 · ClinicalTrials.gov registry record · Phase 2
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,558
- Enrollment target
NCT03398148 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 1,558 participants.
The verdict
NCT03398148, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,558 participants
- Enrollment target
Study Summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Interventions
- DRUG placebo for risankizumab
- DRUG risankizumab SC
- DRUG risankizumab IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,558 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2023-05-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03398148
The ClinicalTrials.gov registry entry for NCT03398148 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,558 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 is the first listed.
NCT03398148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03398148 about?
NCT03398148 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis". The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2...
What is the current status of trial NCT03398148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,558 participants. The study started on 2018-03-07. Estimated completion is 2023-05-11.
What interventions are being tested in trial NCT03398148?
The interventions under investigation include: placebo for risankizumab (DRUG), risankizumab SC (DRUG), risankizumab IV (DRUG).
Who is sponsoring clinical trial NCT03398148?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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