NCT06496620

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: Uniquity One (UNI) · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
BIOLOGICAL	Biological: Solrikitug low dose	Solrikitug subcutaneous injection
BIOLOGICAL	Biological: Solrikitug high dose	Solrikitug subcutaneous injection
OTHER	Placebo	Placebo subcutaneous injection

Timeline

• Start date: 2024-08-14
• Primary completion: 2026-06-30
• Completion: 2026-10-31
• First posted: 2024-07-11
• Last updated: 2026-03-23

Locations

118 sites across 5 countries: United States, Australia, Canada, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study