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)
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178 — Sun City, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (179 Sites)
Showing the first 25 of 179 sites.
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178 — Sun City, Arizona
- Kindred Medical Institute - Corona /ID# 262075 — Corona, California
- Southern California Res. Ctr. /ID# 256612 — Coronado, California
- Valley Clinical Trials, LLC dba Flourish Research /ID# 256610 — Covina, California
- Newport Huntington Medical Group /ID# 256622 — Huntington Beach, California
- Om Research LLC /ID# 259645 — Lancaster, California
- Om Research LLC /ID# 267523 — Lancaster, California
- Clinnova Research - Orange /ID# 270138 — Orange, California
- University of California, Irvine Medical Center /ID# 259677 — Orange, California
- Prospective Research Innovations Inc. /ID# 267856 — Rancho Cucamonga, California
- University of California San Francisco - Mission Bay /ID# 267529 — San Francisco, California
- Amicis Research Center - Valencia /ID# 269158 — Valencia, California
- OM Research LLC /ID# 268735 — Victorville, California
- Danbury Hospital, Western Connecticut Health Network /ID# 261851 — Danbury, Connecticut
- Novum Research /ID# 269223 — Clermont, Florida
- Research Associates of South Florida, LLC /ID# 261627 — Coral Gables, Florida
- University of Florida College of Medicine /ID# 261248 — Gainesville, Florida
- Auzmer Research /ID# 261437 — Lakeland, Florida
- Cfagi Llc /Id# 262005 — Maitland, Florida
- Atlantic Medical Research /ID# 256471 — Margate, Florida
- Homestead Associates in Research /ID# 259643 — Miami, Florida
- University of Miami /ID# 256587 — Miami, Florida
- JD Medical Group, LLC /ID# 262185 — Miami, Florida
- Gastroenterology Group Naples /ID# 256566 — Naples, Florida
- Sarkis Clinical Trials - Ocala /ID# 267840 — Ocala, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) — Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease — Birmingham, Alabama
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. — Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients — San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis — Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.