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

NCT06496620 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NSI-8226-205
• Study Type: interventional
• Target: 171
• Locations: 5 countries
• Sites: 118

Brief 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).

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in blood eosinophil counts

  To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo

  Through week 12

Secondary Outcomes (1)

• Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)

  Through week 12 To week 28

Study Arms (3)

Biological: Solrikitug High Dose

EXPERIMENTAL

Solrikitug

Biological: Biological: Solrikitug high dose

Placebo

OTHER

Placebo

Other: Placebo

Biological: Solrikitug Low Dose

EXPERIMENTAL

Solrikitug

Biological: Biological: Solrikitug low dose

Interventions

Biological: Solrikitug high dose BIOLOGICAL

Solrikitug subcutaneous injection

Biological: Solrikitug High Dose

Placebo OTHER

Placebo subcutaneous injection

Placebo

Biological: Solrikitug low dose BIOLOGICAL

Solrikitug subcutaneous injection

Biological: Solrikitug Low Dose

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uniquity One (UNI): lead
• DevPro Biopharma: collaborator

Study Sites (118)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

Syed Research Consultants

Sheffield, Alabama, 35660, United States

RECRUITING

Phoenix Medical Group

Peoria, Arizona, 85381, United States

RECRUITING

Epic Medical Research-Surprise

Sun City, Arizona, 85351, United States

RECRUITING

Alliance for Multispecialty Research

Tempe, Arizona, 85281, United States

RECRUITING

Novak Clinical Research

Tucson, Arizona, 85741, United States

RECRUITING

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

RECRUITING

Ark Clinical Research - Ballinger

Long Beach, California, 90815, United States

RECRUITING

Downtown LA Research Center, Inc.

Los Angeles, California, 90017, United States

RECRUITING

Newport Native MD, Inc.

Newport Beach, California, 92663, United States

RECRUITING

OM Research

Oxnard, California, 93036, United States

RECRUITING

Prospective Research Innovations, Inc.

Rancho Cucamonga, California, 91730, United States

RECRUITING

Velocity Clinical Research - Denver

Englewood, Colorado, 80110, United States

RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

WITHDRAWN

Access Research Institute

Brooksville, Florida, 34613, United States

RECRUITING

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

RECRUITING

Clinical Research of West Florida - Clearwater

Clearwater, Florida, 33765, United States

RECRUITING

JY Research Institute

Cutler Bay, Florida, 33189, United States

RECRUITING

Hillcrest Medical Research, LLC

DeLand, Florida, 32720, United States

RECRUITING

North Florida Foundation for Research and Education

Gainesville, Florida, 32608, United States

WITHDRAWN

Direct Helper Research Center

Hialeah, Florida, 33012, United States

RECRUITING

Homestead Associates in Research Inc.

Homestead, Florida, 33033, United States

RECRUITING

AppleMed Research Group, LLC

Miami, Florida, 33126, United States

RECRUITING

Y&L Advanced Health Care, Inc.

Miami, Florida, 33144, United States

RECRUITING

Reliant Medical Research LLC

Miami, Florida, 33165, United States

RECRUITING

Valencia Medical & Research Center

Miami, Florida, 33174, United States

RECRUITING

De La Cruz Research Center, LLC

Miami, Florida, 33184, United States

RECRUITING

Coral Research Clinic Corporation

Miami, Florida, 33186, United States

RECRUITING

Pro-Care Research Center, Corp.

Miami Gardens, Florida, 33014, United States

RECRUITING

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

RECRUITING

Florida Institute for Clinical Research

Orlando, Florida, 32825, United States

RECRUITING

Sarasota Clinical Research

Sarasota, Florida, 34239, United States

RECRUITING

TBC Research

Tamarac, Florida, 33321, United States

RECRUITING

Clinical Research of West Florida - Tampa

Tampa, Florida, 33606, United States

RECRUITING

Appalachian Clinical Research, LLC

Adairsville, Georgia, 30103, United States

RECRUITING

Pulmonology, Sleep, Asthma, and Allergy Center - Dublin

Dublin, Georgia, 31021, United States

COMPLETED

CPCC - Research, LLC

East Point, Georgia, 30344, United States

RECRUITING

Centricity Research

Rincon, Georgia, 31326, United States

RECRUITING

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

COMPLETED

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, 61606, United States

RECRUITING

Indiana Medical Research Institute

Merrillville, Indiana, 46410, United States

COMPLETED

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

WITHDRAWN

The Research Group of Lexington, LLC

Lexington, Kentucky, 40503, United States

COMPLETED

Tandem Clinical Research

Metairie, Louisiana, 70006, United States

RECRUITING

Care Access - Shreveport

Shreveport, Louisiana, 71105, United States

RECRUITING

Mayflower Clinical

South Dartmouth, Massachusetts, 02747, United States

RECRUITING

Revival Research Institute, LLC

Dearborn, Michigan, 48126, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48207, United States

RECRUITING

Pulmonary Research Institute of SE Michigan

Farmington Hills, Michigan, 48336, United States

RECRUITING

Revive Research Institute

Southfield, Michigan, 48075, United States

RECRUITING

Midwest Chest Consultants

Saint Charles, Missouri, 63301, United States

NOT YET RECRUITING

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

RECRUITING

Henderson Trials

Henderson, Nevada, 89052, United States

RECRUITING

Rutgers, The State University of New Jersy

New Brunswick, New Jersey, 08901, United States

RECRUITING

Certified Research Associates Finger Lakes Medical Research, LLC

Cortland, New York, 13045, United States

RECRUITING

Corning Center for Clinical Research Smith Allergy & Asthma Specialists

Horseheads, New York, 14845, United States

RECRUITING

Northwell Health

New Hyde Park, New York, 11042, United States

WITHDRAWN

OnSite Clinical Solutions

Charlotte, North Carolina, 28277, United States

RECRUITING

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

RECRUITING

Triad Clinical Trials

Greensboro, North Carolina, 27410, United States

RECRUITING

Peters Medical Research

High Point, North Carolina, 27260, United States

RECRUITING

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, 28078, United States

RECRUITING

Accellacare Wilmington

Wilmington, North Carolina, 28401, United States

COMPLETED

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

WITHDRAWN

Remington Davis

Columbus, Ohio, 43215, United States

RECRUITING

NexGen Research

Lima, Ohio, 45801, United States

RECRUITING

OK Clinical Research

Edmond, Oklahoma, 73034, United States

RECRUITING

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon, 97257, United States

COMPLETED

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

RECRUITING

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Pittsburgh/UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

RECRUITING

AnMed Health

Anderson, South Carolina, 29621, United States

RECRUITING

Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29245, United States

RECRUITING

Velocity Clinical Research - Columbia

Columbia, South Carolina, 29204, United States

RECRUITING

Velocity Clinical Research - Gaffney

Gaffney, South Carolina, 29340, United States

RECRUITING

Velocity Clinical Research - Greenville

Greenville, South Carolina, 29615, United States

COMPLETED

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, 29303, United States

RECRUITING

Velocity Clinical Research - Union

Union, South Carolina, 29379, United States

RECRUITING

Pulmonary & Sleep Specialists

Dickson, Tennessee, 37055, United States

COMPLETED

Premier Research Center, LLC

Hendersonville, Tennessee, 37075, United States

RECRUITING

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

RECRUITING

TTS Research

Boerne, Texas, 78006, United States

NOT YET RECRUITING

Proactive RGV

Brownsville, Texas, 78520, United States

RECRUITING

Ten20 Clinical Research, LLC

Carrollton, Texas, 75010, United States

RECRUITING

IntraCare Health Center

Dallas, Texas, 75254, United States

RECRUITING

IntraCare Clinical

Greenville, Texas, 75401, United States

RECRUITING

Axsendo Clinical Research

Houston, Texas, 77030, United States

COMPLETED

Gulf Coast Clinical Research

Houston, Texas, 77070, United States

RECRUITING

R & H Clinical Research

Katy, Texas, 77494, United States

RECRUITING

IntraCare Health Center

McKinney, Texas, 75071, United States

RECRUITING

SMS Clinical Research

Mesquite, Texas, 75149, United States

RECRUITING

ADP Clinical Research

Splendora, Texas, 77372, United States

RECRUITING

Alpine Research Organization, Inc.

Layton, Utah, 84041, United States

RECRUITING

Velocity Clinical Research - Hampton

Hampton, Virginia, 23666, United States

RECRUITING

Core Clinical

Everett, Washington, 98201, United States

WITHDRAWN

Confluence Health

Wenatchee, Washington, 98801, United States

WITHDRAWN

Momentum Taringa

Taringa, Brisbane, QLD 4068, Australia

RECRUITING

Northside Health

Coffs Harbour, New South Wales, 2450, Australia

RECRUITING

Momentum St. Leonards

Sydney, New South Wales, 2065, Australia

RECRUITING

Momentum Wellers Hill

Tarragindi, Queensland, 4121, Australia

COMPLETED

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 5A6, Canada

WITHDRAWN

Pacific Clinical Research Network Auckland - PCRN West Auckland

New Lynn, Auckland, 0600, New Zealand

RECRUITING

Momentum Wellington

Mount Cook, Wellington Region, 6021, New Zealand

RECRUITING

Pacific Clinical Research Network Auckland - PCRN Auckland

Auckland, 1024, New Zealand

RECRUITING

New Zealand Respiratory & Sleep Institute (NZRSI)

Auckland, 1051, New Zealand

RECRUITING

Momentum Hawke's Bay

Hastings, 4122, New Zealand

COMPLETED

Momentum Tauranga

Tauranga, 3110, New Zealand

RECRUITING

Momentum Kapiti

Waikanae, 5036, New Zealand

RECRUITING

The Medicines Evaluation Unit, an IQVIA business

Wythenshawe, Manchester, M23 9QZGB, United Kingdom

RECRUITING

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Velocity Clinical Research High Wycombe

High Wycombe, HP11 2QW, United Kingdom

RECRUITING

Velocity Clinical Research - Bristol

London, N12 8BU, United Kingdom

RECRUITING

Queen Anne Street Medical Centre

London, W1T 6AH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew W Lee, MD

  Vice President, Clinical Research

  STUDY DIRECTOR

Central Study Contacts

Uniquity One Clinical Trials

CONTACT

484-267-2500; ClinicalTrials@uniquity.com

Anushri Walsh

CONTACT

973-983-3700; awalsh@devprobiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

NZ (7); GB (5); US (101); CA (1); AU (4)