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

August 9, 2026 updated by: Uniquity One (UNI)

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 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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Brisbane
      • Taringa, Brisbane, Australia, QLD 4068
        • Momentum Taringa
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Northside Health
      • Sydney, New South Wales, Australia, 2065
        • Momentum St. Leonards
    • Queensland
      • Tarragindi, Queensland, Australia, 4121
        • Momentum Wellers Hill
  • New Zealand
      • Auckland, New Zealand, 1024
        • Pacific Clinical Research Network Auckland - PCRN Auckland
      • Auckland, New Zealand, 1051
        • New Zealand Respiratory & Sleep Institute (NZRSI)
      • Hastings, New Zealand, 4122
        • Momentum Hawke's Bay
      • Tauranga, New Zealand, 3110
        • Momentum Tauranga
      • Waikanae, New Zealand, 5036
        • Momentum Kapiti
    • Auckland
      • New Lynn, Auckland, New Zealand, 0600
        • Pacific Clinical Research Network Auckland - PCRN West Auckland
    • Wellington Region
      • Mount Cook, Wellington Region, New Zealand, 6021
        • Momentum Wellington
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals NHS Foundation Trust
      • High Wycombe, United Kingdom, HP11 2QW
        • Velocity Clinical Research High Wycombe
      • London, United Kingdom, W1T 6AH
        • Queen Anne Street Medical Centre
      • London, United Kingdom, N12 8BU
        • Velocity Clinical Research - Bristol
    • Manchester
      • Wythenshawe, Manchester, United Kingdom, M23 9QZGB
        • The Medicines Evaluation Unit, an IQVIA business
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama At Birmingham Hospital
      • Sheffield, Alabama, United States, 35660
        • Syed Research Consultants
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Phoenix Medical Group
      • Sun City, Arizona, United States, 85351
        • Epic Medical Research-Surprise
      • Tempe, Arizona, United States, 85281
        • Alliance for Multispecialty Research
      • Tucson, Arizona, United States, 85741
        • Novak Clinical Research
    • California
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
      • Long Beach, California, United States, 90815
        • Ark Clinical Research - Ballinger
      • Los Angeles, California, United States, 90017
        • Downtown LA Research Center, Inc.
      • Newport Beach, California, United States, 92663
        • Newport Native MD, Inc.
      • Oxnard, California, United States, 93036
        • Om Research
      • Rancho Cucamonga, California, United States, 91730
        • Prospective Research Innovations, Inc.
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Velocity Clinical Research - Denver
    • Florida
      • Brooksville, Florida, United States, 34613
        • Access Research Institute
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida, Inc.
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida - Clearwater
      • Cutler Bay, Florida, United States, 33189
        • JY Research Institute
      • DeLand, Florida, United States, 32720
        • Hillcrest Medical Research, LLC
      • Hialeah, Florida, United States, 33012
        • Direct Helper Research Center
      • Homestead, Florida, United States, 33033
        • Homestead Associates in Research Inc.
      • Miami, Florida, United States, 33184
        • De La Cruz Research Center, LLC
      • Miami, Florida, United States, 33126
        • AppleMed Research Group, LLC
      • Miami, Florida, United States, 33144
        • Y&L Advanced Health Care, Inc.
      • Miami, Florida, United States, 33165
        • Reliant Medical Research LLC
      • Miami, Florida, United States, 33174
        • Valencia Medical & Research Center
      • Miami, Florida, United States, 33186
        • Coral Research Clinic Corporation
      • Miami Gardens, Florida, United States, 33014
        • Pro-Care Research Center, Corp.
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic, Inc.
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical Research
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
      • Tamarac, Florida, United States, 33321
        • TBC Research
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida - Tampa
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Appalachian Clinical Research, LLC
      • Dublin, Georgia, United States, 31021
        • Pulmonology, Sleep, Asthma, and Allergy Center - Dublin
      • East Point, Georgia, United States, 30344
        • CPCC - Research, LLC
      • Rincon, Georgia, United States, 31326
        • Centricity Research
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise
    • Illinois
      • Peoria, Illinois, United States, 61606
        • OSF HealthCare Saint Francis Medical Center
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Indiana Medical Research Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Tandem Clinical Research
      • Shreveport, Louisiana, United States, 71105
        • Care Access - Shreveport
    • Massachusetts
      • South Dartmouth, Massachusetts, United States, 02747
        • Mayflower Clinical
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Revival Research Institute, LLC
      • Detroit, Michigan, United States, 48207
        • Henry Ford Health System
      • Farmington Hills, Michigan, United States, 48336
        • Pulmonary Research Institute of SE Michigan
      • Southfield, Michigan, United States, 48075
        • Revive Research Institute
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Midwest Chest Consultants
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, Inc.
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Henderson Trials
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers, The State University of New Jersy
    • New York
      • Cortland, New York, United States, 13045
        • Certified Research Associates Finger Lakes Medical Research, LLC
      • Horseheads, New York, United States, 14845
        • Corning Center for Clinical Research Smith Allergy & Asthma Specialists
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Onsite Clinical Solutions
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research of Gastonia
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials
      • High Point, North Carolina, United States, 27260
        • Peters Medical Research
      • Huntersville, North Carolina, United States, 28078
        • Advanced Respiratory and Sleep Medicine
      • Wilmington, North Carolina, United States, 28401
        • Accellacare Wilmington
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington Davis
      • Lima, Ohio, United States, 45801
        • Nexgen Research
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • OK Clinical Research
    • Oregon
      • Grants Pass, Oregon, United States, 97257
        • Velocity Clinical Research - Grants Pass
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research - Medford
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh/UPMC
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research - Anderson
      • Charleston, South Carolina, United States, 29245
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29204
        • Velocity Clinical Research - Columbia
      • Gaffney, South Carolina, United States, 29340
        • Velocity Clinical Research - Gaffney
      • Greenville, South Carolina, United States, 29615
        • Velocity Clinical Research - Greenville
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, United States, 29303
        • Velocity Clinical Research - Spartanburg
      • Union, South Carolina, United States, 29379
        • Velocity Clinical Research - Union
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • Pulmonary & Sleep Specialists
      • Hendersonville, Tennessee, United States, 37075
        • Premier Research Center, LLC
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research & Development
    • Texas
      • Boerne, Texas, United States, 78006
        • TTS Research
      • Brownsville, Texas, United States, 78520
        • Proactive RGV
      • Carrollton, Texas, United States, 75010
        • Ten20 Clinical Research, LLC
      • Dallas, Texas, United States, 75254
        • IntraCare Health Center
      • Greenville, Texas, United States, 75401
        • IntraCare Clinical
      • Houston, Texas, United States, 77070
        • Gulf Coast Clinical Research
      • Houston, Texas, United States, 77030
        • Axsendo Clinical Research
      • Katy, Texas, United States, 77494
        • R & H Clinical Research
      • McKinney, Texas, United States, 75071
        • IntraCare Health Center
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research
      • Splendora, Texas, United States, 77372
        • ADP Clinical Research
    • Utah
      • Layton, Utah, United States, 84041
        • Alpine Research Organization, Inc.
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Velocity Clinical Research - Hampton

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo
Other: Placebo
Placebo subcutaneous injection
Experimental: Biological: Solrikitug High Dose
Solrikitug
Biological: Biological: Solrikitug high dose
Solrikitug subcutaneous injection
Experimental: Biological: Solrikitug Low Dose
Solrikitug
Biological: Biological: Solrikitug low dose
Solrikitug subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in blood eosinophil counts
Time Frame: Through week 12
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Through week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Through week 12 To week 28
To assess the safety and tolerability of multiple doses of solrikitug
Through week 12 To week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniquity One (UNI)

Collaborators

DevPro Biopharma

Investigators

  • Study Director: Andrew W Lee, MD, Vice President, Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSI-8226-205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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