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

Uniquity One (UNI)

Status and phase: Enrolling; Phase 2

Conditions: COPD

Treatments: Other: Placebo; Drug: Biological: Solrikitug high dose; Drug: Biological: Solrikitug low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06496620

NSI-8226-205

Details and patient eligibility

About

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).

Full 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.

Enrollment: 171 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups

Biological: Solrikitug High Dose

Experimental group

Description:

Solrikitug

Treatment:

Drug: Biological: Solrikitug high dose

Placebo

Other group

Description:

Placebo

Treatment:

Other: Placebo

Biological: Solrikitug Low Dose

Experimental group

Description:

Solrikitug

Treatment:

Drug: Biological: Solrikitug low dose