A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT06063967

Run by

AbbVie

People needed

289

Starts

2023-11-15

Expected to finish

2027-03-01

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
• Participant meets the following disease activity criteria:
• Moderate to severe CD as assessed by CDAI
• Endoscopic evidence of mucosal inflammation as documented by a SES-CD
• Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

You may not qualify if…

• Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
• Participants with unstable doses of concomitant Crohn's disease therapy.
• Participants with prior exposure to p19 inhibitors.
• Participants with complications of Crohn's disease.
• Participants having an ostomy or ileoanal pouch.

Where it is running

• Kindred Medical Institute - Corona /ID# 262075 — Corona, California, United States
• Southern California Res. Ctr. /ID# 256612 — Coronado, California, United States
• Valley Clinical Trials, LLC dba Flourish Research /ID# 256610 — Covina, California, United States
• Newport Huntington Medical Group /ID# 256622 — Huntington Beach, California, United States
• Om Research LLC /ID# 259645 — Lancaster, California, United States
• Om Research LLC /ID# 267523 — Lancaster, California, United States
• Clinnova Research - Orange /ID# 270138 — Orange, California, United States
• University of California, Irvine Medical Center /ID# 259677 — Orange, California, United States
• Prospective Research Innovations Inc. /ID# 267856 — Rancho Cucamonga, California, United States
• University of California San Francisco - Mission Bay /ID# 267529 — San Francisco, California, United States
• Amicis Research Center - Valencia /ID# 269158 — Valencia, California, United States
• OM Research LLC /ID# 268735 — Victorville, California, United States
• Danbury Hospital, Western Connecticut Health Network /ID# 261851 — Danbury, Connecticut, United States
• Novum Research /ID# 269223 — Clermont, Florida, United States
• Research Associates of South Florida, LLC /ID# 261627 — Coral Gables, Florida, United States
• University of Florida College of Medicine /ID# 261248 — Gainesville, Florida, United States
• Auzmer Research /ID# 261437 — Lakeland, Florida, United States
• Cfagi Llc /Id# 262005 — Maitland, Florida, United States
• Atlantic Medical Research /ID# 256471 — Margate, Florida, United States
• Homestead Associates in Research /ID# 259643 — Miami, Florida, United States
• University of Miami /ID# 256587 — Miami, Florida, United States
• JD Medical Group, LLC /ID# 262185 — Miami, Florida, United States
• Gastroenterology Group Naples /ID# 256566 — Naples, Florida, United States
• Sarkis Clinical Trials - Ocala /ID# 267840 — Ocala, Florida, United States
• Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178 — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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