A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Risankizumab — DRUG
  Intravenous (IV) Infusion
• Risankizumab — DRUG
  Subcutaneous (SC) injection
• Vedolizumab — DRUG
  Intravenous (IV) infusion

Study Details

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs). Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide. For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study. The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Key Dates

Start date

Jun 17, 2025

Status verified

Jun 2026

Primary completion

Aug 31, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

573 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Risankizumab Group
  An induction dose of risankizumab intravenous (IV) will be administered at Baseline and Weeks 4 and 8. Starting at Week 12, participants will then receive either a lower or higher subcutaneous (SC) risankizumab maintenance dose, followed by the same dose every 8 weeks with the last dose at Week 44.
• Active Comparator: Vedolizumab Group
  Vedolizumab IV will be administered at Baseline, Weeks 2 and 6, and every 8 weeks with the last dose of vedolizumab IV at Week 46.

Primary Outcome Measure

Percentage of Risankizumab Group Participants Achieving Endoscopic Improvement As Compared to The Vedolizumab Group [ Time Frame: At Week 48 ]

Locations (74)

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