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NCT03398135 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis (UC), sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 1,242
- Enrollment target
- 20
- Study locations
NCT03398135 is a Phase 3 study of Ulcerative Colitis (UC) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 1,242 participants, above the 692-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT03398135, a Phase 3 study of Ulcerative Colitis (UC), is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,242 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Conditions Studied
Interventions
- DRUG risankizumab
- DRUG placebo for risankizumab
Study Locations (20)
Florida
- South Lake Pain Institute, Inc /ID# 162859 - Clermont
- Ctr for Advanced Gastroenterol /ID# 202820 - Maitland
- University of Miami /ID# 160456 - Miami
- Coral Research Clinic /ID# 158608 - Miami
- South Florida Research Ph I-IV, Inc. /ID# 161844 - Miami
- Gastroenterology Group Naples /ID# 165210 - Naples
- Advanced Research Institute, Inc /ID# 161945 - New Port Richey
- Advent Health /ID# 160393 - Orlando
- Endoscopic Research, Inc. /ID# 206709 - Orlando
California
- Southern California Res. Ctr. /ID# 169659 - Coronado
- Hoag Memorial Hosp Presbyterian /ID# 218347 - Irvine
- UC San Diego Health System /ID# 160430 - La Jolla
- United Medical Doctors /ID# 158574 - Los Alamitos
- Cedars-Sinai Medical Center /ID# 163848 - Los Angeles
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934 - Los Angeles
- UCSF Medical Center - Mount Zion /ID# 201209 - San Francisco
Colorado
- Peak Gastroenterology Associates, PC /ID# 165838 - Colorado Springs
- Rocky Mountain Pediatric Gastroenterology /ID# 207173 - Lone Tree
Connecticut
- Duplicate_Medical Research Center of CT /ID# 160287 - Hamden
- Yale Univ Digestive Diseases /ID# 213265 - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,242 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2029-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03398135
The ClinicalTrials.gov registry entry for NCT03398135 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,242 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 692-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (79% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ulcerative Colitis (UC) appearing as the primary indexed condition, and to 2 interventions - of which risankizumab is the first listed.
NCT03398135 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03398135 about?
NCT03398135 is a clinical study titled "A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis". The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous T...
What is the current status of trial NCT03398135?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,242 participants. The study started on 2018-08-28. Estimated completion is 2029-02.
What conditions does trial NCT03398135 study?
This clinical trial studies the following conditions: Ulcerative Colitis (UC).
What interventions are being tested in trial NCT03398135?
The interventions under investigation include: risankizumab (DRUG), placebo for risankizumab (DRUG).
Who is sponsoring clinical trial NCT03398135?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03398135 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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