Completed Digestion, Kidneys & Other Organs NIHR-supported project

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust Newcastle Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Apr 2025

In plain English

AI plain-English summary

A new antibody treatment, Vixarelimab, is being tested in patients with moderate to severe Ulcerative Colitis who have not responded to existing therapies. Ulcerative Colitis is a chronic inflammatory disease of the rectum and colon that causes bloody diarrhoea. Current advanced therapies only achieve remission in a minority of patients and carry risks of serious infections, cardiovascular events, and other complications. This study addresses the urgent need for safer, more durable treatment options. If Vixarelimab proves effective, it could offer a new therapeutic pathway for patients who have exhausted current options. The drug is a first-in-class, fully human monoclonal antibody, meaning it targets the disease through a novel mechanism. Success could reduce the burden of hospitalisations and invasive procedures for thousands of patients, while also lowering the risk of treatment-related side effects that currently limit long-term disease control. The study includes an active treatment extension, allowing all participants—including those initially on placebo—to receive the drug after the induction period, which may provide real-world insight into sustained response.

View original technical description
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 UCThis 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.

Researchers

Andrew King (Principal Investigator)

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