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PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Risankizumab-800CW 4.5 mg for Ulcerative Colitis (UC)

Crohn\'s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor.

Official registry: https://clinicaltrials.gov/study/NCT06606808 · University Medical Center Groningen · enrollment listed as 18

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-800CW 4.5 mg, Risankizumab-800CW 15 mg, or Risankizumab-800CW 25 mg. The registry lists allocation as randomized. Crohn\'s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD).

They plan to enroll about 18 people at Groningen. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease

Interventions: Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg, Risankizumab-800CW 25 mg, Risankizumab-800CW optimal dose

Primary outcome (registry wording): Determine the safety of risankizumab-800CW in IBD

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Established IBD diagnosis
  • Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \> 60 μg/g
  • Patients must be eligible for risankizumab therapy
  • Minimum age of 18 years
  • Clinical indication for an endoscopic procedure
  • who can join for part B:
  • Patients must be on risankizumab therapy for at least 14 weeks

Public study contact (from the registry)

Wouter B Nagengast, MD, PharmD, PhD

+31(0)503612620

w.b.nagengast@umcg.nl

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

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT06606808 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 NCT06606808?

Phase 1 / 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 NCT06606808?

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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