RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Risankizumab for Crohn's Disease

Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss.

Official registry: https://clinicaltrials.gov/study/NCT07697456 · AbbVie · enrollment listed as 2,000

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Risankizumab, Trosunilimab, or ABBV-701. The registry lists allocation as randomized. Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract.

They plan to enroll about 2,000 people at 66 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Interventions: Risankizumab, Trosunilimab, ABBV-701

Primary outcome (registry wording): Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
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
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

Who the registry excludes

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
Participants with \>3 prior bowel resections
Participants with previous small bowel resection(s) of combined length \>100 cm
Participants with prior colectomy (total or subtotal)

Public study contact (from the registry)

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

66 listed

Digestive Health Specialists /ID# 280827 — Dothan, Alabama (recruiting)
Elite Clinical Studies /ID# 280477 — Phoenix, Arizona (recruiting)
Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084 — Sun City, Arizona (recruiting)
Clinnova Research /ID# 280509 — Anaheim, California (recruiting)
Southern California Res. Ctr /ID# 280476 — Coronado, California (recruiting)
Gastro Care Institute /ID# 281071 — Lancaster, California (recruiting)
United Medical Doctors - Los Alamitos /ID# 281125 — Los Alamitos, California (recruiting)
Inland Empire Liver Foundation - Rialto /ID# 280775 — Rialto, California (recruiting)
Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507 — Colorado Springs, Colorado (recruiting)
Synergy Healthcare - Bradenton /ID# 284157 — Bradenton, Florida (recruiting)
Clinical Research of Osceola /ID# 280593 — Kissimmee, Florida (recruiting)
Florida Center For Gastroenterology - Largo /ID# 281059 — Largo, Florida (recruiting)

+ 5 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07697456 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07697456?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07697456?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary