Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants with Severe Asthma
Research type
Research Study
Full title
A Long-Term Extension Study to Evaluate Safety and Efficacy of Verekitug (UPB-101) in Adult Participants with Severe Asthma who Completed the VALIANT Trial
IRAS ID
1011475
Contact name
Shea Clingerman
Contact email
Sponsor organisation
Upstream Bio Inc.
Eudract number
2024-519469-23
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This clinical trial is studying an investigational drug called verekitug (also known as UPB-101) as a potential treatment for severe asthma. Verekitug is thought to work by reducing inflammation, which is a main characteristic of severe asthma. Verekitug targets a protein that controls the immune system’s response to inflammation. The main purpose of this study is to learn more about the long-term use of verekitug. All participants in this study will receive verekitug; no participant will receive only placebo (dummy). Another purpose of this study is to learn the effect of long-term use of verekitug 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. This study is divided into a treatment period of 60 weeks and a follow-up period, with end of study (EOS) visit performed 16 weeks after the last dose of study intervention. Participants will be assigned to receive one of the following: 100 mg verekitug every 12 weeks or 400 mg verekitug every 24 weeks administered by injection subcutaneously. No matter the dose, each participant will receive the same number of injections and have the same visit schedule. Participants will also undergo a range of blood tests and other investigations during the study to monitor safety and effects of the study drug on the organs. Each participant is expected to be in the study for about 64 weeks, and must have completed the VALIANT study before entering this one. The study will be conducted at about 150 sites globally with up to 436 participants.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0351
Date of REC Opinion
1 Jul 2025
REC opinion
Further Information Favourable Opinion