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NCT03105102 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 1,336
- Enrollment target
- 20
- Study locations
NCT03105102: Active Phase 3 study of Crohn's Disease, sponsored by AbbVie.
NCT03105102 is a Phase 3 study of Crohn's Disease that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 1,336 participants, below the 2,382-participant average among 105 other Crohn's Disease trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03105102, a Phase 3 study of Crohn's Disease, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,336 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150.
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 |
What the registry record for NCT03105102 still lists
NCT03105102 is an interventional study that assigns participants to a tested intervention. Its 1,336 participants enrollment target places it among the larger protocols in the corpus, below the 2,382-participant average among 105 other Crohn's Disease trials with a reported enrollment target (44% lower).
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.
NCT03105102 names 20 study sites across 6 states, led by California, Florida, Arizona.
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.
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).
Who is sponsoring clinical trial NCT03105102?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03105102's enrollment target sits among peer trials
1,336 6th of 105 higher than 100 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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.
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