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A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
NCT06063967 · View on ClinicalTrials.gov ↗
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 |
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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. 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 289 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 2 interventions — of which 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: NCT06063967 reports 20 study locations spanning 4 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06063967?
The interventions under investigation include: Risankizumab SC (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 NCT06063967?
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 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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