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

Phase 2

Recruiting

• Conditions: COPD
• Interventions: Other: Placebo

• Registration Number: NCT06496620
• Lead Sponsor: Uniquity One (UNI)

Brief Summary

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 (COPD).

Detailed Description

This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD.

Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.

Study Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Study Start: 2024-08-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• 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.
• At Screening FEV1/FVC ratio must be <0.70, and Post-bronchodilator FEV1 must be ≥40% to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
• Symptomatic (COPD Assessment Test [CAT] Score ≥10) at Screening Visit 1.
• Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.

Exclusion Criteria

• Female participant who is pregnant or breastfeeding.
• Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
• Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
• Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
• Undergone major lung surgery, within 1 year of Screening Visit 1.
• Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in blood eosinophil counts	Through week 12	To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo

Secondary Outcome Measures

Name	Time	Method
Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)	Through week 12 To week 28	To assess the safety and tolerability of multiple doses of solrikitug

Trial Locations

Locations (48)

Research Site 051; 🇺🇸 Surprise, Arizona, United States

Research Site 033; 🇺🇸 Tempe, Arizona, United States

Research Site 032; 🇺🇸 Los Angeles, California, United States

Research Site 041; 🇺🇸 Oxnard, California, United States

Research Site 049; 🇺🇸 Clearwater, Florida, United States

Research Site 052; 🇺🇸 Miami, Florida, United States

Research Site 042; 🇺🇸 Lexington, Kentucky, United States

Research Site 037; 🇺🇸 Farmington Hills, Michigan, United States

Research Site 062; 🇺🇸 Missoula, Montana, United States

Research Site 044; 🇺🇸 Cortland, New York, United States

Scroll for more (38 remaining)