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NCT06063967 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
A Phase 3 study of Crohn's Disease, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 289
- Enrollment target
- 20
- Study locations
NCT06063967 is a Phase 3 study of Crohn's Disease that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 289 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT06063967, 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
- 289 participants
- Enrollment target
- 20
- Study locations
Study Summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Conditions Studied
Interventions
- DRUG Risankizumab SC
- DRUG Placebo for risankizumab
Study Locations (20)
California
- Kindred Medical Institute - Corona /ID# 262075 - Corona
- Southern California Res. Ctr. /ID# 256612 - Coronado
- Valley Clinical Trials, LLC dba Flourish Research /ID# 256610 - Covina
- Newport Huntington Medical Group /ID# 256622 - Huntington Beach
- Om Research LLC /ID# 259645 - Lancaster
- Om Research LLC /ID# 267523 - Lancaster
- Clinnova Research - Orange /ID# 270138 - Orange
- University of California, Irvine Medical Center /ID# 259677 - Orange
- Prospective Research Innovations Inc. /ID# 267856 - Rancho Cucamonga
- University of California San Francisco - Mission Bay /ID# 267529 - San Francisco
- Amicis Research Center - Valencia /ID# 269158 - Valencia
- OM Research LLC /ID# 268735 - Victorville
Florida
- Novum Research /ID# 269223 - Clermont
- Research Associates of South Florida, LLC /ID# 261627 - Coral Gables
- University of Florida College of Medicine /ID# 261248 - Gainesville
- Auzmer Research /ID# 261437 - Lakeland
- Cfagi Llc /Id# 262005 - Maitland
- Atlantic Medical Research /ID# 256471 - Margate
Arizona
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178 - Sun City
Connecticut
- Danbury Hospital, Western Connecticut Health Network /ID# 261851 - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06063967
The ClinicalTrials.gov registry entry for NCT06063967 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (88% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Risankizumab SC is the first listed.
NCT06063967 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06063967 about?
NCT06063967 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.". Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effect...
What is the current status of trial NCT06063967?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 289 participants. The study started on 2023-11-15. Estimated completion is 2027-03.
What conditions does trial NCT06063967 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06063967?
The interventions under investigation include: Risankizumab SC (DRUG), Placebo for risankizumab (DRUG).
Who is sponsoring clinical trial NCT06063967?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06063967 being conducted?
This trial has 20 study locations across Arizona, California, 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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