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

Purpose

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).

Condition

  • COPD

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Biological: Solrikitug High Dose 		Solrikitug
  • Biological: Biological: Solrikitug high dose
    Solrikitug subcutaneous injection
Other
Placebo 		Placebo
  • Other: Placebo
    Placebo subcutaneous injection
Experimental
Biological: Solrikitug Low Dose 		Solrikitug
  • Biological: Biological: Solrikitug low dose
    Solrikitug subcutaneous injection

Recruiting Locations

University of Alabama at Birmingham Hospital
Birmingham, Alabama 35294
Contact:
Research Site 034

More Details

Status
Recruiting
Sponsor
Uniquity One (UNI)

Study Contact

Uniquity One Clinical Trials
484-267-2500
ClinicalTrials@uniquity.com

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.