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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: Completed Phase 2 study, sponsored by AbbVie.
NCT03398148 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 1,558 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1071% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher sc
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 |
What the finished NCT03398148 record still lists
NCT03398148 is an interventional study that assigns participants to a tested intervention. Its 1,558 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1071% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo for risankizumab is the first listed.
NCT03398148 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03398148's enrollment target sits among peer trials
1,558 11th of 2000 higher than 1,990 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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