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

March 19, 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

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 (Estimated)

171

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 Contact

Study Contact Backup

Study Locations

  • Australia
    • Brisbane
      • Taringa, Brisbane, Australia, QLD 4068
        • Recruiting
        • Momentum Taringa
        • Contact:
          • Research Site 106
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Recruiting
        • Northside Health
        • Contact:
          • Research Site 078
      • Sydney, New South Wales, Australia, 2065
        • Recruiting
        • Momentum St. Leonards
        • Contact:
          • Research Site 103
    • Queensland
      • Tarragindi, Queensland, Australia, 4121
        • Completed
        • Momentum Wellers Hill
  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8X 5A6
        • Withdrawn
        • Dr. Syed Anees Medicine Professional Corporation
  • New Zealand
      • Auckland, New Zealand, 1024
        • Recruiting
        • Pacific Clinical Research Network Auckland - PCRN Auckland
        • Contact:
          • Research Site 091
      • Auckland, New Zealand, 1051
        • Recruiting
        • New Zealand Respiratory & Sleep Institute (NZRSI)
        • Contact:
          • Research Site 071
      • Hastings, New Zealand, 4122
        • Completed
        • Momentum Hawke's Bay
      • Tauranga, New Zealand, 3110
        • Recruiting
        • Momentum Tauranga
        • Contact:
          • Research Site 116
      • Waikanae, New Zealand, 5036
        • Recruiting
        • Momentum Kapiti
        • Contact:
          • Research Site 094
    • Auckland
      • New Lynn, Auckland, New Zealand, 0600
        • Recruiting
        • Pacific Clinical Research Network Auckland - PCRN West Auckland
        • Contact:
          • Research Site 092
    • Wellington Region
      • Mount Cook, Wellington Region, New Zealand, 6021
        • Recruiting
        • Momentum Wellington
        • Contact:
          • Research Site 093
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Recruiting
        • Bradford Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Research Site 080
      • High Wycombe, United Kingdom, HP11 2QW
        • Recruiting
        • Velocity Clinical Research High Wycombe
        • Contact:
          • Research Site 096
      • London, United Kingdom, W1T 6AH
        • Recruiting
        • Queen Anne Street Medical Centre
        • Contact:
          • Research Site 074
      • London, United Kingdom, N12 8BU
        • Recruiting
        • Velocity Clinical Research - Bristol
        • Contact:
          • Research Site 081
    • Manchester
      • Wythenshawe, Manchester, United Kingdom, M23 9QZGB
        • Recruiting
        • The Medicines Evaluation Unit, an IQVIA business
        • Contact:
          • Research Site 073
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama At Birmingham Hospital
        • Contact:
          • Research Site 034
      • Sheffield, Alabama, United States, 35660
        • Recruiting
        • Syed Research Consultants
        • Contact:
          • Research Site 066
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Phoenix Medical Group
        • Contact:
          • Research Site 099
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Epic Medical Research-Surprise
        • Contact:
          • Research Site 051
      • Tempe, Arizona, United States, 85281
        • Recruiting
        • Alliance for Multispecialty Research
        • Contact:
          • Research Site 033
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Novak Clinical Research
        • Contact:
          • Research Site 095
    • California
      • Lancaster, California, United States, 93534
        • Recruiting
        • Antelope Valley Clinical Trials
        • Contact:
          • Research Site 031
      • Long Beach, California, United States, 90815
        • Recruiting
        • Ark Clinical Research - Ballinger
        • Contact:
          • Research Site 107
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Downtown LA Research Center, Inc.
        • Contact:
          • Research Site 032
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Newport Native Md, Inc.
        • Contact:
          • Research Site 018
      • Oxnard, California, United States, 93036
        • Recruiting
        • Om Research
        • Contact:
          • Research Site 041
      • Rancho Cucamonga, California, United States, 91730
        • Recruiting
        • Prospective Research Innovations, Inc.
        • Contact:
          • Research Site 056
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Recruiting
        • Velocity Clinical Research - Denver
        • Contact:
          • Research Site 020
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Withdrawn
        • Yale University School of Medicine
    • Florida
      • Brooksville, Florida, United States, 34613
        • Recruiting
        • Access Research Institute
        • Contact:
          • Research Site 070
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Innovative Research of West Florida, Inc.
        • Contact:
          • Research Site 049
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida - Clearwater
        • Contact:
          • Research Site 002
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • JY Research Institute
        • Contact:
          • Research Site 035
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Hillcrest Medical Research, LLC
        • Contact:
          • Research Site 077
      • Gainesville, Florida, United States, 32608
        • Withdrawn
        • North Florida Foundation for Research and Education
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helper Research Center
        • Contact:
          • Research Site 064
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Homestead Associates in Research Inc.
        • Contact:
          • Research Site 057
      • Miami, Florida, United States, 33126
        • Recruiting
        • AppleMed Research Group, LLC
        • Contact:
          • Research Site 111
      • Miami, Florida, United States, 33165
        • Recruiting
        • Reliant Medical Research LLC
        • Contact:
          • Research Site 059
      • Miami, Florida, United States, 33184
        • Recruiting
        • De La Cruz Research Center, LLC
        • Contact:
          • Researcg Site 052
      • Miami, Florida, United States, 33174
        • Recruiting
        • Valencia Medical & Research Center
        • Contact:
          • Research Site 098
      • Miami, Florida, United States, 33144
        • Recruiting
        • Y&L Advanced Health Care, Inc.
        • Contact:
          • Research Site 101
      • Miami, Florida, United States, 33186
        • Recruiting
        • Coral Research Clinic Corporation
        • Contact:
          • Research Site 004
      • Miami Gardens, Florida, United States, 33014
        • Recruiting
        • Pro-Care Research Center, Corp.
        • Contact:
          • Research Site 038
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • San Marcus Research Clinic, Inc.
        • Contact:
          • Research Site 055
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Florida Institute for Clinical Research
        • Contact:
          • Research Site 013
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Clinical Research
        • Contact:
          • Research Site 007
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • TBC Research
        • Contact:
          • Research Site 067
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida - Tampa
        • Contact:
          • Research Site 001
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Recruiting
        • Appalachian Clinical Research, LLC
        • Contact:
          • Research Site 108
      • Dublin, Georgia, United States, 31021
        • Completed
        • Pulmonology, Sleep, Asthma, and Allergy Center - Dublin
      • East Point, Georgia, United States, 30344
        • Recruiting
        • CPCC - Research, LLC
        • Contact:
          • Research Site 110
      • Rincon, Georgia, United States, 31326
        • Recruiting
        • Centricity Research
        • Contact:
          • Research Site 003
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Completed
        • Velocity Clinical Research - Boise
    • Illinois
      • Peoria, Illinois, United States, 61606
        • Recruiting
        • OSF HealthCare Saint Francis Medical Center
        • Contact:
          • Research Site 079
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Completed
        • Indiana Medical Research Institute
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Withdrawn
        • The University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Completed
        • The Research Group of Lexington, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Tandem Clinical Research
        • Contact:
          • Research Site 026
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Care Access - Shreveport
        • Contact:
          • Research Site 097
    • Massachusetts
      • South Dartmouth, Massachusetts, United States, 02747
        • Recruiting
        • Mayflower Clinical
        • Contact:
          • Research Site 017
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Revival Research Institute, LLC
        • Contact:
          • Research Site 114
      • Detroit, Michigan, United States, 48207
        • Recruiting
        • Henry Ford Health System
        • Contact:
          • Research Site 065
      • Farmington Hills, Michigan, United States, 48336
        • Recruiting
        • Pulmonary Research Institute of SE Michigan
        • Contact:
          • Research Site 037
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Revive Research Institute
        • Contact:
          • Research Site 085
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Not yet recruiting
        • Midwest Chest Consultants
        • Contact:
          • Resarch Site 009
    • Montana
      • Missoula, Montana, United States, 59808
        • Recruiting
        • Montana Medical Research, Inc.
        • Contact:
          • Research Site 062
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Henderson Trials
        • Contact:
          • Research Site 015
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers, The State University of New Jersy
        • Contact:
          • Research Site 105
    • New York
      • Cortland, New York, United States, 13045
        • Recruiting
        • Certified Research Associates Finger Lakes Medical Research, LLC
        • Contact:
          • Research Site 044
      • Horseheads, New York, United States, 14845
        • Recruiting
        • Corning Center for Clinical Research Smith Allergy & Asthma Specialists
        • Contact:
          • Research Site 043
      • New Hyde Park, New York, United States, 11042
        • Withdrawn
        • Northwell Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Onsite Clinical Solutions
        • Contact:
          • Research Site 050
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
        • Contact:
          • Research Site 005
      • Greensboro, North Carolina, United States, 27410
        • Recruiting
        • Triad Clinical Trials
        • Contact:
          • Research Site 104
      • High Point, North Carolina, United States, 27260
        • Recruiting
        • Peters Medical Research
        • Contact:
          • Research Site 008
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Advanced Respiratory and Sleep Medicine
        • Contact:
          • Research Site 039
      • Wilmington, North Carolina, United States, 28401
        • Completed
        • Accellacare Wilmington
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Southeastern Research Center
        • Contact:
          • Research Site 014
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Withdrawn
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Remington Davis
        • Contact:
          • Research Site 036
      • Lima, Ohio, United States, 45801
        • Recruiting
        • Nexgen Research
        • Contact:
          • Research Site 086
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • OK Clinical Research
        • Contact:
          • Research Site 115
    • Oregon
      • Grants Pass, Oregon, United States, 97257
        • Completed
        • Velocity Clinical Research - Grants Pass
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Velocity Clinical Research - Medford
        • Contact:
          • Research Site 011
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • Clinical Research Associates of Central PA
        • Contact:
          • Research Site 083
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
        • Contact:
          • Research Site 063
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy and Clinical Immunology Associates
        • Contact:
          • Research Site 053
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh/UPMC
        • Contact:
          • Research Site 061
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health
        • Contact:
          • Research Site 117
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • Velocity Clinical Research - Anderson
        • Contact:
          • Research Site 023
      • Charleston, South Carolina, United States, 29245
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Research Site 069
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • Velocity Clinical Research - Columbia
        • Contact:
          • Research Site 028
      • Gaffney, South Carolina, United States, 29340
        • Recruiting
        • Velocity Clinical Research - Gaffney
        • Contact:
          • Research Site 030
      • Greenville, South Carolina, United States, 29615
        • Completed
        • Velocity Clinical Research - Greenville
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
        • Contact:
          • Research Site 010
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Velocity Clinical Research - Spartanburg
        • Contact:
          • Research Site 024
      • Union, South Carolina, United States, 29379
        • Recruiting
        • Velocity Clinical Research - Union
        • Contact:
          • Research Site 029
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • Completed
        • Pulmonary & Sleep Specialists
      • Hendersonville, Tennessee, United States, 37075
        • Recruiting
        • Premier Research Center, LLC
        • Contact:
          • Research Site 040
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • New Phase Research & Development
        • Contact:
          • Research Site 048
    • Texas
      • Boerne, Texas, United States, 78006
        • Not yet recruiting
        • TTS Research
        • Contact:
          • Research Site 016
      • Brownsville, Texas, United States, 78520
        • Recruiting
        • Proactive RGV
        • Contact:
          • Research Site 076
      • Carrollton, Texas, United States, 75010
        • Recruiting
        • Ten20 Clinical Research, LLC
        • Contact:
          • Research Site 112
      • Dallas, Texas, United States, 75254
        • Recruiting
        • IntraCare Health Center
        • Contact:
          • Research Site 012
      • Greenville, Texas, United States, 75401
        • Recruiting
        • IntraCare Clinical
        • Contact:
          • Research Site 089
      • Houston, Texas, United States, 77070
        • Recruiting
        • Gulf Coast Clinical Research
        • Contact:
          • Research Site 025
      • Houston, Texas, United States, 77030
        • Completed
        • Axsendo Clinical Research
      • Katy, Texas, United States, 77494
        • Recruiting
        • R & H Clinical Research
        • Contact:
          • Research Site 087
      • McKinney, Texas, United States, 75071
        • Recruiting
        • IntraCare Health Center
        • Contact:
          • Research Site 012
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • SMS Clinical Research
        • Contact:
          • Research Site 084
      • Splendora, Texas, United States, 77372
        • Recruiting
        • ADP Clinical Research
        • Contact:
          • Research Site 109
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • Alpine Research Organization, Inc.
        • Contact:
          • Research Site 088
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Recruiting
        • Velocity Clinical Research - Hampton
        • Contact:
          • Research Site 019
    • Washington
      • Everett, Washington, United States, 98201
        • Withdrawn
        • Core Clinical
      • Wenatchee, Washington, United States, 98801
        • Withdrawn
        • Confluence Health

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)

June 30, 2026

Study Completion (Estimated)

October 31, 2026

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)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 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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