Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, platform basket trial evaluating safety and efficacy of advanced therapies in adults with moderately to severely active Crohn's disease or ulcerative colitis. Substudy 1 assesses risankizumab plus trosunilimab (ABBV-466); Substudy 2 assesses risankizumab plus ABBV-701 (ABBV-7066). Participants may undergo enrollment across multiple substudies, with criteria based on disease activity scores and prior therapy failure. Eligible participants will receive combination therapy and be monitored for responses and adverse events. The sponsor is AbbVie, with participating sites in Arizona and Alabama.

Why it matters

Who can join: the full rules

Inclusion Criteria:

CD specific:

* Crohn's Disease Activity Index (CDAI) score of ≥ 220
* Confirmed diagnosis of CD at least 90 days prior to Baseline
* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
* Demonstrated failure of 1 or more therapy for CD

UC specific:

* Confirmed diagnosis of UC at least 90 days prior to Baseline
* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
* Demonstrated failure of 1 or more therapy for UC

Exclusion Criteria:

* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
* Participants with surgical bowel resection within the past 3 months prior to Baseline

CD specific:

* Participants with \>3 prior bowel resections
* Participants with previous small bowel resection(s) of combined length \>100 cm

UC specific:

* Participants with prior colectomy (total or subtotal)
* Participants with extent of disease limited to \< 10 cm of rectum

Where it's running

• Digestive Health Specialists /ID# 280827
  Dothan, Alabama, United States Recruiting
• Elite Clinical Studies /ID# 280477
  Phoenix, Arizona, United States Recruiting
• Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
  Sun City, Arizona, United States Recruiting
• Clinnova Research /ID# 280509
  Anaheim, California, United States Recruiting
• Southern California Res. Ctr /ID# 280476
  Coronado, California, United States Recruiting
• Gastro Care Institute /ID# 281071
  Lancaster, California, United States Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.