PEGASUS
Research type
Research Study
Full title
Master Protocol: A Phase 1b, non-randomized, open-label, repeat-dose, single center study utilizing a master protocol to investigate the safety and tolerability of multiple study interventions in advanced therapy naïve participants with moderate to severe ulcerative colitis Sub Protocol: A Phase 1b, non-randomized, open-label, repeat-dose, single center study to investigate the safety and tolerability of aletekitug in advanced therapy naïve participants with moderate to severe ulcerative colitis
IRAS ID
1013278
Contact name
n/a n/a
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
PEGASUS is a clinical trial designed to test the safety and tolerability of new treatments for people with moderate to severe ulcerative colitis (UC). UC is a chronic condition that causes inflammation and sores in the digestive tract, leading to symptoms like stomach pain, diarrhea, and lack of energy. Current treatments for UC often have limited effectiveness, and many patients struggle to achieve long-term relief. This study aims to explore innovative therapies that target different mechanisms of the disease to improve treatment outcomes. The study focuses on participants who have not previously received advanced therapies for UC. It is being conducted at a single center and involves testing of multiple treatments under a master protocol. Each treatment has its own sub-protocol, which outlines specific details about the medication being tested. The first treatment being studied is aletekitug (GSK1070806), which targets IL-18, a protein linked to inflammation in UC. Participants will undergo screening to ensure they meet the eligibility criteria, which include being between 18 and 75 years old and having moderate to severe UC. Once enrolled, participants will receive one study medication periodically over a 12-week period, followed by a safety monitoring period of up to 22 weeks after the last dose. Researchers will closely monitor participants for any side effects or changes in their health, including blood tests, heart monitoring, and other assessments. The study also includes tests to measure how the treatment affects the immune system and gut inflammation. Additional medications may be added, and the goal of the PEGASUS study is to better understand the safety and biological effects of these new treatments.
REC name
London - City & East Research Ethics Committee
REC reference
26/LO/0268
Date of REC Opinion
30 Apr 2026
REC opinion
Further Information Favourable Opinion