Targeted therapies for treating moderate to severe Crohn's disease 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 study evaluates the effectiveness and safety of targeted therapies for adults suffering from moderate to severe Crohn's disease. Participants will be randomized into treatment groups receiving either risankizumab, ABBV-382, or lutikizumab, administered through injections or infusions. The study aims to enroll around 500 participants across approximately 300 sites worldwide, focusing on those who have not responded adequately to existing treatments. The primary goal is to assess the impact of these therapies on disease symptoms and inflammation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants' body weight must be \>= 40 kg at Baseline.
* Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
* CDAI \>= 220 at Baseline.
* Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
* Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.

Exclusion Criteria:

* Participant with history of intolerance to p19 inhibitors, including risankizumab.
* Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.

Where it's running

• Digestive Health Specialists /ID# 266216
  Dothan, Alabama, United States Recruiting
• East View Medical Research /ID# 270377
  Mobile, Alabama, United States Recruiting
• Southern California Res. Ctr /ID# 265549
  Coronado, California, United States Recruiting
• UC San Diego Health System /ID# 265565
  La Jolla, California, United States Recruiting
• uc davis medical center - patient support services building /ID# 265554
  Sacramento, California, United States Recruiting
• Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557
  Colorado Springs, Colorado, United States Recruiting

+205 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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

Similar studies

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.