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

Last updated: February 20, 2025
Sponsor: Uniquity One (UNI)
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Biological: Solrikitug high dose

Biological: Solrikitug low dose

Placebo

Clinical Study ID

NCT06496620
NSI-8226-205
  • Ages 40-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 bythe 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 oftheir COPD, for at least 3 months prior to screening.

Exclusion

Exclusion Criteria:

  • Female participant who is pregnant or breastfeeding.

  • Participant has a known hypersensitivity to any component of the formulation ofsolrikitug, including any of the excipients, or a history of anaphylactic reactionto 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 conditionthat in the opinion of the Investigator or Medical Monitor might obfuscate the studydata.

  • Any other pulmonary disease than COPD that in the opinion of the Investigator, theseverity 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

Total Participants: 171
Treatment Group(s): 3
Primary Treatment: Biological: Solrikitug high dose
Phase: 2
Study Start date:
August 14, 2024
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Research Site 031

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Research Site 018

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Research Site 020

    Englewood, Colorado 80110
    United States

    Active - Recruiting

  • Research Site 002

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Research Site 035

    Cutler Bay, Florida 33189
    United States

    Active - Recruiting

  • Research Site 004

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Research Site 013

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • Research Site 007

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Research Site 001

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Research Site 003

    Rincon, Georgia 31326
    United States

    Active - Recruiting

  • Research Site 021

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Research Site 022

    Merrillville, Indiana 46410
    United States

    Active - Recruiting

  • Research Site 017

    South Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

  • Research Site 009

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Research Site 015

    Henderson, Nevada 89052
    United States

    Active - Recruiting

  • Research Site 005

    Gastonia, North Carolina 28054
    United States

    Active - Recruiting

  • Research Site 008

    High Point, North Carolina 27260
    United States

    Active - Recruiting

  • Research Site 006

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Research Site 014

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Research Site 011

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Research Site 023

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

  • Research Site 028

    Columbia, South Carolina 29204
    United States

    Active - Recruiting

  • Research Site 027

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Research Site 010

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Research Site 024

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Research Site 029

    Union, South Carolina 29379
    United States

    Active - Recruiting

  • Research Site 016

    Boerne, Texas 78006
    United States

    Site Not Available

  • Research Site 025

    Houston, Texas 77070
    United States

    Active - Recruiting

  • Research Site 012

    McKinney, Texas 75071
    United States

    Active - Recruiting

  • Research Site 019

    Hampton, Virginia 23666
    United States

    Active - Recruiting

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