Efficacy and Safety of Verekitug (UPB-101) in Adult Participants with Severe Asthma (VALIANT)
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study to Evaluate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants with Severe Asthma (VALIANT)
IRAS ID
1009019
Contact name
James Lee
Contact email
Sponsor organisation
Upstream Bio Inc
Eudract number
2023-507410-27
Research summary
The sponsor has begun a study of an investigational drug called verekitug (UPB-101) as a potential treatment for severe asthma. Verekitug (UPB-101) is thought to work by reducing inflammation, which is a main characteristic of severe asthma. Verekitug (UPB-101) targets a protein that controls the immune system’s response to inflammation. The main purpose of this study is to learn more about verekitug (UPB-101) by comparing it with placebo. A placebo looks exactly like verekitug (UPB-101) but does not have any verekitug (UPB-101) in it. It only has safe ingredients that do not have any medicinal effects on the body. Researchers use a placebo to see if verekitug (UPB-101) works better or is safer than taking nothing. Another purpose of this study is to learn the effect of verekitug (UPB-101) on participants who also have chronic rhinosinusitis with nasal polyps and/or atopic dermatitis in addition to severe asthma. Chronic rhinosinusitis is the medical term for inflammation (swelling) of the lining of the sinuses and nose which lasts a long time or comes back. Nasal polyps are benign growths inside the nose near the openings to the sinuses. Atopic dermatitis is a skin condition that causes dry, itchy, and inflamed patches of skin.
The study will take place at approximately 150 centres globally with about 436 people recruited who have severe asthma. Study participation is expected to last around 70 weeks with up to 19 clinic visits per participant. Participants will be randomised into one of the following groups: 100 mg verekitug (UPB-101) every 12 weeks, 400 mg verekitug (UPB-101) every 24 weeks, 100 mg verekitug (UPB-101) every 24 weeks, or placebo every 12 weeks. Participants who consent to the study will undergo a range of study procedures including blood tests, lung function tests, and questionnaires completed on an electronic device at various time points, in addition to the study drug or placebo, and will be closely monitored by the study doctor.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0012
Date of REC Opinion
7 Feb 2024
REC opinion
Further Information Favourable Opinion