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

NCT ID: NCT06496620

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-14

Study Completion Date

2026-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Biological: Solrikitug High Dose

Solrikitug

Group Type EXPERIMENTAL

Biological: Solrikitug high dose

Intervention Type BIOLOGICAL

Solrikitug subcutaneous injection

Placebo

Placebo

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo subcutaneous injection

Biological: Solrikitug Low Dose

Solrikitug

Group Type EXPERIMENTAL

Biological: Solrikitug low dose

Intervention Type BIOLOGICAL

Solrikitug subcutaneous injection

Interventions

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Biological: Solrikitug low dose

Solrikitug subcutaneous injection

Intervention Type BIOLOGICAL

Biological: Solrikitug high dose

Solrikitug subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Placebo subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DevPro Biopharma

INDUSTRY

Sponsor Role collaborator

Uniquity One (UNI)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew W Lee, MD

Role: STUDY_DIRECTOR

Vice President, Clinical Research

Locations

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Research Site 034

Birmingham, Alabama, United States

Site Status RECRUITING

Research Site 099

Peoria, Arizona, United States

Site Status RECRUITING

Research Site 051

Surprise, Arizona, United States

Site Status RECRUITING

Research Site 033

Tempe, Arizona, United States

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Research Site 095

Tucson, Arizona, United States

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Research Site 031

Lancaster, California, United States

Site Status RECRUITING

Research Site 107

Long Beach, California, United States

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Research Site 032

Los Angeles, California, United States

Site Status RECRUITING

Research Site 018

Newport Beach, California, United States

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Research Site 041

Oxnard, California, United States

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Research Site 056

Rancho Cucamonga, California, United States

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Research Site 020

Englewood, Colorado, United States

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Research Site 070

Brooksville, Florida, United States

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Research Site 049

Clearwater, Florida, United States

Site Status RECRUITING

Research Site 002

Clearwater, Florida, United States

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Research Site 035

Cutler Bay, Florida, United States

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Research Site 064

Hialeah, Florida, United States

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Research Site 057

Homestead, Florida, United States

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Research Site 111

Miami, Florida, United States

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Research Site 101

Miami, Florida, United States

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Research Site 059

Miami, Florida, United States

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Research Site 098

Miami, Florida, United States

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Research Site 052

Miami, Florida, United States

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Research Site 004

Miami, Florida, United States

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Research Site 038

Miami Gardens, Florida, United States

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Research Site 055

Miami Lakes, Florida, United States

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Research Site 013

Orlando, Florida, United States

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Research Site 007

Sarasota, Florida, United States

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Research Site 067

Tamarac, Florida, United States

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Research Site 001

Tampa, Florida, United States

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Research Site 108

Adairsville, Georgia, United States

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Research Site 046

Dublin, Georgia, United States

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Research Site 110

East Point, Georgia, United States

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Research Site 003

Rincon, Georgia, United States

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Research Site 021

Meridian, Idaho, United States

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Research Site 079

Peoria, Illinois, United States

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Research Site 022

Merrillville, Indiana, United States

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Research Site 042

Lexington, Kentucky, United States

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Research Site 097

Shreveport, Louisiana, United States

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Research Site 017

Russells Mills, Massachusetts, United States

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Research Site 114

Dearborn, Michigan, United States

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Research Site 037

Farmington Hills, Michigan, United States

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Research Site 085

Southfield, Michigan, United States

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Research Site 009

Saint Charles, Missouri, United States

Site Status NOT_YET_RECRUITING

Research Site 062

Missoula, Montana, United States

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Research Site 015

Henderson, Nevada, United States

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Research Site 044

Cortland, New York, United States

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Research Site 043

Horseheads, New York, United States

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Research Site 050

Charlotte, North Carolina, United States

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Research Site 005

Gastonia, North Carolina, United States

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Research Site 104

Greensboro, North Carolina, United States

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Research Site 008

High Point, North Carolina, United States

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Research Site 039

Huntersville, North Carolina, United States

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Research Site 006

Wilmington, North Carolina, United States

Site Status RECRUITING

Research Site 014

Winston-Salem, North Carolina, United States

Site Status NOT_YET_RECRUITING

Research Site 036

Columbus, Ohio, United States

Site Status RECRUITING

Research Site 086

Lima, Ohio, United States

Site Status RECRUITING

Research Site 047

Grants Pass, Oregon, United States

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Research Site 011

Medford, Oregon, United States

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Research Site 083

DuBois, Pennsylvania, United States

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Research Site 053

Pittsburgh, Pennsylvania, United States

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Research Site 023

Anderson, South Carolina, United States

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Research Site 028

Columbia, South Carolina, United States

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Research Site 027

Greenville, South Carolina, United States

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Research Site 010

Rock Hill, South Carolina, United States

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Research Site 024

Spartanburg, South Carolina, United States

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Research Site 029

Union, South Carolina, United States

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Research Site 040

Hendersonville, Tennessee, United States

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Research Site 048

Knoxville, Tennessee, United States

Site Status RECRUITING

Research Site 016

Boerne, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site 076

Brownsville, Texas, United States

Site Status RECRUITING

Research Site 112

Carrollton, Texas, United States

Site Status RECRUITING

Research Site 089

Greenville, Texas, United States

Site Status RECRUITING

Research Site 060

Houston, Texas, United States

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Research Site 025

Houston, Texas, United States

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Research Site 087

Katy, Texas, United States

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Research Site 012

McKinney, Texas, United States

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Research Site 084

Mesquite, Texas, United States

Site Status RECRUITING

Research Site 109

Splendora, Texas, United States

Site Status RECRUITING

Research Site 088

Layton, Utah, United States

Site Status RECRUITING

Research Site 019

Hampton, Virginia, United States

Site Status RECRUITING

Research Site 090

Tarragindi, Queensland, Australia

Site Status RECRUITING

Research Site 094

Waikanae, , New Zealand

Site Status RECRUITING

Research Site 096

High Wycombe, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia New Zealand United Kingdom

Central Contacts

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Uniquity One Clinical Trials

Role: CONTACT

Phone: 484-267-2500

Email: [email protected]

Anushri Walsh

Role: CONTACT

Phone: 973-983-3700

Email: [email protected]

Facility Contacts

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Other Identifiers

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NSI-8226-205

Identifier Type: -

Identifier Source: org_study_id