Home › Trials › NCT06063967

Assessing the safety and effectiveness of risankizumab for Crohn's disease

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

Phase 3 Interventional AbbVie · NCT06063967

This study is testing if a new injection called risankizumab can help adults with moderate to severe Crohn's disease feel better and manage their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment276 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsrisankizumab
Locations177 sites (Sun City, Arizona and 176 other locations)
Trial IDNCT06063967 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of risankizumab, a subcutaneous treatment, for adults with moderately to severely active Crohn's disease. Participants will be assigned to receive either risankizumab or a placebo in a structured approach over three periods, with adjustments based on their response to treatment. The study aims to determine how well risankizumab can improve disease activity and manage symptoms associated with Crohn's disease.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of Crohn's disease who have not responded adequately to previous therapies.

Not a fit: Patients with ulcerative colitis, unstable therapy doses, or prior exposure to specific treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Crohn's disease symptoms and enhance the quality of life for patients.

How similar studies have performed: Previous studies have shown promising results with similar biologic treatments for Crohn's disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Participant meets the following disease activity criteria:

  1. Moderate to severe CD as assessed by CDAI
  2. 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.

Exclusion Criteria:

* 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 this trial is running

Sun City, Arizona and 176 other locations

+127 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseRisankizumab, Skyrizi, Crohn's Disease, ABBV-066
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.