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Evaluating Solrikitug for COPD treatment

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)

Phase 2 Interventional Uniquity One (UNI) · NCT06496620

This study is testing a new treatment called Solrikitug to see if it helps people with COPD breathe better when added to their usual care.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment171 (estimated)
Ages40 Years to 75 Years
SexAll
SponsorUniquity One (UNI) Industry-sponsored
Locations118 sites (Birmingham, Alabama and 117 other locations)
Trial IDNCT06496620 on ClinicalTrials.gov

What this trial studies

This clinical trial is a 12-week randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Solrikitug in participants with Chronic Obstructive Pulmonary Disease (COPD). Approximately 171 eligible participants will be randomized across 60-90 sites to receive either Solrikitug at two different dose levels or a placebo, administered via subcutaneous injection. The study aims to determine the effectiveness of Solrikitug on top of standard care, with a follow-up period of 16 weeks after treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 75 with a documented diagnosis of COPD and elevated blood eosinophils.

Not a fit: Patients who are pregnant, breastfeeding, or have a known hypersensitivity to Solrikitug or its components may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the management of COPD symptoms and enhance the quality of life for patients.

How similar studies have performed: Other studies have shown promise in using similar biologic approaches for treating COPD, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 117 other locations

+68 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions COPD
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.