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

Description

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).

Conditions

COPD

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
COPD
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Research Site 018, Newport Beach, California, United States, 92663

Englewood

Research Site 020, Englewood, Colorado, United States, 80110

Clearwater

Research Site 002, Clearwater, Florida, United States, 33765

Miami

Research Site 004, Miami, Florida, United States, 33186

Orlando

Research Site 013, Orlando, Florida, United States, 32825

Sarasota

Research Site 007, Sarasota, Florida, United States, 34239

Tampa

Research Site 001, Tampa, Florida, United States, 33606

Rincon

Research Site 003, Rincon, Georgia, United States, 31326

Meridian

Research Site 021, Meridian, Idaho, United States, 83642

Merrillville

Research Site 022, Merrillville, Indiana, United States, 46410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * At least 40 years of age and no older than 70 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.
  • * 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.

Ages Eligible for Study

40 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Uniquity One (UNI),

Andrew W Lee, MD, STUDY_DIRECTOR, Vice President, Clinical Research

Study Record Dates

2025-08-31