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A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
NCT03105102 · View on ClinicalTrials.gov ↗
Study Summary
The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
Conditions Studied
Interventions
- DRUG Placebo for Risankizumab SC
- DRUG Risankizumab IV
- DRUG Placebo for Risankizumab IV
- DRUG Risankizumab SC
- DRUG Risankizumab On-Body Injector (OBI)
Study Locations (20)
California
- Southern California Res. Ctr. /ID# 211991 — Coronado
- Duplicate_Newport Huntington Medical Group /ID# 213035 — Huntington Beach
- UC San Diego Health Systems /ID# 155555 — La Jolla
- United Medical Doctors /ID# 207888 — Los Alamitos
- TLC Clinical Research Inc /ID# 212719 — Los Angeles
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657 — Los Angeles
- United Medical Doctors - Murrieta /ID# 158300 — Murrieta
- University of California San Francisco - Mission Bay /ID# 157127 — San Francisco
- Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839 — West Hollywood
Florida
- Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262 — Brandon
- South Lake Pain Institute, Inc /ID# 162808 — Clermont
- Omega Research Maitland, LLC /ID# 171082 — DeBary
- Universal Axon Clinical Research /ID# 165428 — Doral
Arizona
- Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884 — Mesa
- Phoenix VA Health Care System /ID# 162264 — Phoenix
- Banner - University Medical Center Tucson /ID# 158502 — Tucson
Colorado
- Peak Gastroenterology Associates, PC /ID# 165843 — Colorado Springs
- Rocky Mountain Pediatric Gastroenterology /ID# 207170 — Lone Tree
Arkansas
- Atria Clinical Research /ID# 164505 — Little Rock
Connecticut
- Duplicate_Western Connecticut Medical Group /ID# 165879 — Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,336 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2026-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03105102
The ClinicalTrials.gov registry entry for NCT03105102 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 1,336 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 Crohn's Disease appearing as the primary indexed condition, and to 5 interventions — of which Placebo for Risankizumab SC 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: NCT03105102 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT03105102 about?
NCT03105102 is a clinical study titled "A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease". The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intr...
What is the current status of trial NCT03105102?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,336 participants. The study started on 2018-04-09. Estimated completion is 2026-05.
What conditions does trial NCT03105102 study?
This clinical trial studies the following conditions: Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03105102?
The interventions under investigation include: Placebo for Risankizumab SC (DRUG), Risankizumab IV (DRUG), Placebo for Risankizumab IV (DRUG), Risankizumab SC (DRUG), Risankizumab On-Body Injector (OBI) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03105102?
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 NCT03105102 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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