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A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
NCT03398135 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03398135 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03398135?
The interventions under investigation include: risankizumab (DRUG), placebo for risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03398135?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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