What is solrikitug studying for COPD?

Solrikitug is being studied to evaluate its safety, tolerability, and how it works in the body for people with COPD. Researchers want to understand if different doses of solrikitug affect blood eosinophil levels and lung function. The study is sponsored by Uniquity One (UNI) and compares solrikitug to a placebo alongside standard COPD treatments.

Who may be eligible for this COPD clinical trial?

Adults aged 40 to 75 years with a COPD diagnosis for at least one year may qualify. Participants must have elevated blood eosinophils, be symptomatic with a COPD Assessment Test score of 10 or more, and be using at least two inhaled maintenance medications. Please review eligibility criteria for more details.

Is there any cost to participate in this COPD clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 40Years - 75Years

All Genders

ID06496620

A 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

Led by Uniquity One (UNI) · Updated on 2026-03-23

171

Participants Needed

118

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease COPD to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

CONDITIONS

Brief Title

A Study to Evaluate Solrikitug in Participants With COPD (ZION)

Who Can Participate

Age: 40Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

At least 40 years of age and no older than 75 years.
Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
FEV1/FVC ratio less than 0.70, and post-bronchodilator FEV1 between 40% and less than 80% predicted normal value.
Symptomatic with a COPD Assessment Test (CAT) score of 10 or higher at Screening.
Using two or more inhaled maintenance medications for COPD for at least 3 months before screening.

You will not qualify if you...

Female participants who are pregnant or breastfeeding.
Known hypersensitivity to solrikitug components or history of anaphylactic reaction to any therapeutic monoclonal antibody.
History or evidence of significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal, or other major diseases or malignancies.
Any pulmonary disease other than COPD that may impact study conduct.
Major lung surgery within 1 year prior to screening.
Lower respiratory tract infection requiring antibiotics within 6 weeks prior to screening.

Research Team

Uniquity One Clinical Trials

Anushri Walsh

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