Study to assess Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (ZION)
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (ZION)
IRAS ID
1012059
Contact name
Andrew Lee
Contact email
Sponsor organisation
NI One Inc. (doing business as Uniquity One)
Clinicaltrials.gov Identifier
Research summary
The sponsor has begun a study of an investigational drug called Solrikitug (NSI-8226) as a potential treatment for Chronic Obstructive Pulmonary Disease (COPD). Solrikitug is what is known as a monoclonal antibody (proteins that affect immune response) which is given as an injection in hopes of improving COPD symptoms. The main purpose of this study is to evaluate whether solrikitug lowers the amount of a type of blood cell called an eosinophil that can be increased in people with COPD. In addition, this study will compare the safety of two different doses of solrikitug to placebo (a product without real medicine included). Approximately 171 participants will take part in this study at approximately 90 study site(s) around the world. Participation in this study will last approximately 32 weeks and include approximately 11 visits to the study site. This study is called double-blind because neither the participant nor the study site personnel will know if they receive the placebo or the active study drug. However, in case of a medical emergency, the study doctor(s) can find out which study treatment the participant is receiving if that is needed for appropriate medical treatment or to continue in the study. The study will involve a screening timeframe up to 4 weeks; 12 weeks of study treatment period and 16 weeks of follow-up. In this study, some participants will receive a subcutaneous dose of solrikitug (375 mg) while others will receive subcutaneous placebo. Placebo will look like the study drug but will not contain active drug.
Participants will receive the same number of injections, 2 injections on each dosing day, for a total of 6 injections of solrikitug or placebo in the arm. The study treatment group receiving active study drug will only be given to the participant during the participation of the study and not after the study is over. Participants must be male or female at least 40 years of age and no older than 75 years at Screening Visit 1.REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0548
Date of REC Opinion
9 Sep 2025
REC opinion
Further Information Favourable Opinion