A Phase II study of Vixarelimab in patients with moderate to severe UC

• Research type

  Research Study

• Full title

  A Phase II, multicenter induction study with an active treatment extension to evaluate the efficacy, safety, and pharmacokinetics of Vixarelimab in patients with moderate to severe Ulcerative Colitis

• IRAS ID

  1009306

• Contact name

  Jenn Pangilinan

• Contact email

  pabustan@gene.com

• Sponsor organisation

  Genentech, Inc.

• Clinicaltrials.gov Identifier

  NCT06137183

• Research summary

  Ulcerative Colitis (UC) is a Chronic inflammatory disease affecting the rectum and colon, commonly presents with bloody diarrhea.
  There are advanced therapies available to treat Ulcerative Colitis, however the remission rates is only 20%-30% and these advanced therapies have been associated with serious infections, infusion reactions, cardiovascular events, thrombosis, and malignancies.
  There remains an unmet need for additional safe UC treatments that are both well tolerated and have durable efficacy.

  Vixarelimab is a first-in-class, fully human, monoclonal antibody.
  Study GA44839 is the first study of vixarelimab in patients with UC

  This is a Phase II, multicenter, randomised, parallel-group, double-blind, placebo-controlled, dose-ranging study study will evaluate the efficacy, safety, and pharmacokinetics of vixarelimab compared with placebo in patients with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

  The study consists of a screening period (up to 35 days), treatment period (48-week), and a safety follow-up period for 10 weeks following the final dose of study treatment.

  Treatment period (48 weeks) consists of The induction period (Weeks 0-12) and an optional active treatment extension (ATE) period (Weeks 12-48). After completion of the induction period, irrespective of clinical response or remission, all patients will receive vixarelimab, including patients who received placebo during the induction period.
  The total duration of study participation is expected to be approximately 25 weeks for patients who complete the induction treatment period, and 61 weeks for patients who complete the optional ATE.

  In this study participants will undergo assessments which include physical exams, Hepatitis B and C, HIV and TB screen, blood, urine, screening endoscopy and colonic biopsies, ECG, and Clinical outcome assessments.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  24/SC/0029

• Date of REC Opinion

  2 May 2024

• REC opinion

  Further Information Favourable Opinion