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NCT06496620PHASE2Recruiting

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

Uniquity One (UNI)

Start Date

8/14/2024

Completion Date

10/31/2026

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).

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.

Eligibility Criteria

Age Range: 40 years to 75 years

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.

Interventions

BIOLOGICAL

Biological: Solrikitug low dose

BIOLOGICAL

Biological: Solrikitug high dose

OTHER

Placebo

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Conditions

COPD

Locations

University of Alabama at Birmingham Hospital

Birmingham, Alabama 35294

United States

Syed Research Consultants

Sheffield, Alabama 35660

United States

Phoenix Medical Group

Peoria, Arizona 85381

United States

Epic Medical Research-Surprise

Sun City, Arizona 85351

United States

Alliance for Multispecialty Research

Tempe, Arizona 85281

United States

Novak Clinical Research

Tucson, Arizona 85741

United States

Antelope Valley Clinical Trials

Lancaster, California 93534

United States

Ark Clinical Research - Ballinger

Long Beach, California 90815

United States

Downtown LA Research Center, Inc.

Los Angeles, California 90017

United States

Newport Native MD, Inc.

Newport Beach, California 92663

United States

OM Research

Oxnard, California 93036

United States

Prospective Research Innovations, Inc.

Rancho Cucamonga, California 91730

United States

Velocity Clinical Research - Denver

Englewood, Colorado 80110

United States

Yale University School of Medicine

New Haven, Connecticut 06510

United States

Access Research Institute

Brooksville, Florida 34613

United States

Innovative Research of West Florida, Inc.

Clearwater, Florida 33756

United States

Clinical Research of West Florida - Clearwater

Clearwater, Florida 33765

United States

JY Research Institute

Cutler Bay, Florida 33189

United States

Hillcrest Medical Research, LLC

DeLand, Florida 32720

United States

North Florida Foundation for Research and Education

Gainesville, Florida 32608

United States

Direct Helper Research Center

Hialeah, Florida 33012

United States

Homestead Associates in Research Inc.

Homestead, Florida 33033

United States

AppleMed Research Group, LLC

Miami, Florida 33126

United States

Y&L Advanced Health Care, Inc.

Miami, Florida 33144

United States

Reliant Medical Research LLC

Miami, Florida 33165

United States

Valencia Medical & Research Center

Miami, Florida 33174

United States

De La Cruz Research Center, LLC

Miami, Florida 33184

United States

Coral Research Clinic Corporation

Miami, Florida 33186

United States

Pro-Care Research Center, Corp.

Miami Gardens, Florida 33014

United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida 33014

United States

Florida Institute for Clinical Research

Orlando, Florida 32825

United States

Sarasota Clinical Research

Sarasota, Florida 34239

United States

TBC Research

Tamarac, Florida 33321

United States

Clinical Research of West Florida - Tampa

Tampa, Florida 33606

United States

Appalachian Clinical Research, LLC

Adairsville, Georgia 30103

United States

Pulmonology, Sleep, Asthma, and Allergy Center - Dublin

Dublin, Georgia 31021

United States

CPCC - Research, LLC

East Point, Georgia 30344

United States

Centricity Research

Rincon, Georgia 31326

United States

Velocity Clinical Research - Boise

Meridian, Idaho 83642

United States

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois 61606

United States

Indiana Medical Research Institute

Merrillville, Indiana 46410

United States

The University of Kansas Medical Center

Kansas City, Kansas 66160

United States

The Research Group of Lexington, LLC

Lexington, Kentucky 40503

United States

Tandem Clinical Research

Metairie, Louisiana 70006

United States

Care Access - Shreveport

Shreveport, Louisiana 71105

United States

Mayflower Clinical

South Dartmouth, Massachusetts 02747

United States

Revival Research Institute, LLC

Dearborn, Michigan 48126

United States

Henry Ford Health System

Detroit, Michigan 48207

United States

Pulmonary Research Institute of SE Michigan

Farmington Hills, Michigan 48336

United States

Revive Research Institute

Southfield, Michigan 48075

United States

Midwest Chest Consultants

Saint Charles, Missouri 63301

United States

Montana Medical Research, Inc.

Missoula, Montana 59808

United States

Henderson Trials

Henderson, Nevada 89052

United States

Rutgers, The State University of New Jersy

New Brunswick, New Jersey 08901

United States

Certified Research Associates Finger Lakes Medical Research, LLC

Cortland, New York 13045

United States

Corning Center for Clinical Research Smith Allergy & Asthma Specialists

Horseheads, New York 14845

United States

Northwell Health

New Hyde Park, New York 11042

United States

OnSite Clinical Solutions

Charlotte, North Carolina 28277

United States

Clinical Research of Gastonia

Gastonia, North Carolina 28054

United States

Triad Clinical Trials

Greensboro, North Carolina 27410

United States

Peters Medical Research

High Point, North Carolina 27260

United States

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina 28078

United States

Accellacare Wilmington

Wilmington, North Carolina 28401

United States

Southeastern Research Center

Winston-Salem, North Carolina 27103

United States

MetroHealth Medical Center

Cleveland, Ohio 44109

United States

Remington Davis

Columbus, Ohio 43215

United States

NexGen Research

Lima, Ohio 45801

United States

OK Clinical Research

Edmond, Oklahoma 73034

United States

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon 97257

United States

Velocity Clinical Research - Medford

Medford, Oregon 97504

United States

Clinical Research Associates of Central PA

DuBois, Pennsylvania 15801

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

University of Pittsburgh/UPMC

Pittsburgh, Pennsylvania 15213

United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania 15241

United States

AnMed Health

Anderson, South Carolina 29621

United States

Velocity Clinical Research - Anderson

Anderson, South Carolina 29621

United States

Medical University of South Carolina

Charleston, South Carolina 29245

United States

Velocity Clinical Research - Columbia

Columbia, South Carolina 29204

United States

Velocity Clinical Research - Gaffney

Gaffney, South Carolina 29340

United States

Velocity Clinical Research - Greenville

Greenville, South Carolina 29615

United States

Clinical Research of Rock Hill

Rock Hill, South Carolina 29732

United States

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina 29303

United States

Velocity Clinical Research - Union

Union, South Carolina 29379

United States

Pulmonary & Sleep Specialists

Dickson, Tennessee 37055

United States

Premier Research Center, LLC

Hendersonville, Tennessee 37075

United States

New Phase Research & Development

Knoxville, Tennessee 37909

United States

TTS Research

Boerne, Texas 78006

United States

Proactive RGV

Brownsville, Texas 78520

United States

Ten20 Clinical Research, LLC

Carrollton, Texas 75010

United States

IntraCare Health Center

Dallas, Texas 75254

United States

IntraCare Clinical

Greenville, Texas 75401

United States

Axsendo Clinical Research

Houston, Texas 77030

United States

Gulf Coast Clinical Research

Houston, Texas 77070

United States

R & H Clinical Research

Katy, Texas 77494

United States

IntraCare Health Center

McKinney, Texas 75071

United States

SMS Clinical Research

Mesquite, Texas 75149

United States

ADP Clinical Research

Splendora, Texas 77372

United States

Alpine Research Organization, Inc.

Layton, Utah 84041

United States

Velocity Clinical Research - Hampton

Hampton, Virginia 23666

United States

Core Clinical

Everett, Washington 98201

United States

Confluence Health

Wenatchee, Washington 98801

United States

Momentum Taringa

Taringa, Brisbane QLD 4068

Australia

Northside Health

Coffs Harbour, New South Wales 2450

Australia

Momentum St. Leonards

Sydney, New South Wales 2065

Australia

Momentum Wellers Hill

Tarragindi, Queensland 4121

Australia

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario N8X 5A6

Canada

Pacific Clinical Research Network Auckland - PCRN West Auckland

New Lynn, Auckland 0600

New Zealand

Momentum Wellington

Mount Cook, Wellington Region 6021

New Zealand

Pacific Clinical Research Network Auckland - PCRN Auckland

Auckland, 1024

New Zealand

New Zealand Respiratory & Sleep Institute (NZRSI)

Auckland, 1051

New Zealand

Momentum Hawke's Bay

Hastings, 4122

New Zealand

Momentum Tauranga

Tauranga, 3110

New Zealand

Momentum Kapiti

Waikanae, 5036

New Zealand

The Medicines Evaluation Unit, an IQVIA business

Wythenshawe, Manchester M23 9QZGB

United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6RJ

United Kingdom

Velocity Clinical Research High Wycombe

High Wycombe, HP11 2QW

United Kingdom

Velocity Clinical Research - Bristol

London, N12 8BU

United Kingdom

Queen Anne Street Medical Centre

London, W1T 6AH

United Kingdom