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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Risankizumab for Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss.

Official registry: https://clinicaltrials.gov/study/NCT06548542 · AbbVie · enrollment listed as 590

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, Lutikizumab, or Trosunilimab. The registry lists allocation as randomized. Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels.

They plan to enroll about 590 people at 255 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Interventions: Risankizumab, Lutikizumab, Trosunilimab, Risankizumab, Trosunilimab, ABBV-8736

Primary outcome (registry wording): Percentage of Participants who Achieve Endoscopic Remission

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • 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

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

255 listed

+ 191 sites outside the US on the same record

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT06548542 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 NCT06548542?

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 NCT06548542?

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

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