RecruitingPhase 2NCT06496620

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


Sponsor

Uniquity One (UNI)

Enrollment

171 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (called ZION) is testing whether a new drug called solrikitug can reduce flare-ups and improve breathing in people with COPD (chronic obstructive pulmonary disease) who have elevated levels of a certain immune cell (eosinophils) in their blood. **You may be eligible if...** - You are between 40 and 75 years old with a confirmed COPD diagnosis for at least 12 months - Your breathing test (FEV1/FVC) shows airflow obstruction, and lung function is between 40–80% of normal - You have had at least one COPD flare-up (exacerbation) in the past year - Your blood eosinophil count is elevated at screening - Your COPD symptom score (CAT) is above a certain level **You may NOT be eligible if...** - You have asthma or another significant lung condition - You are a current smoker above a certain level or have recently quit - You have serious heart, liver, or immune system problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBiological: Solrikitug low dose

Solrikitug subcutaneous injection

BIOLOGICALBiological: Solrikitug high dose

Solrikitug subcutaneous injection

OTHERPlacebo

Placebo subcutaneous injection


Locations(118)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Syed Research Consultants

Sheffield, Alabama, United States

Phoenix Medical Group

Peoria, Arizona, United States

Epic Medical Research-Surprise

Sun City, Arizona, United States

Alliance for Multispecialty Research

Tempe, Arizona, United States

Novak Clinical Research

Tucson, Arizona, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Ark Clinical Research - Ballinger

Long Beach, California, United States

Downtown LA Research Center, Inc.

Los Angeles, California, United States

Newport Native MD, Inc.

Newport Beach, California, United States

OM Research

Oxnard, California, United States

Prospective Research Innovations, Inc.

Rancho Cucamonga, California, United States

Velocity Clinical Research - Denver

Englewood, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Access Research Institute

Brooksville, Florida, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Clinical Research of West Florida - Clearwater

Clearwater, Florida, United States

JY Research Institute

Cutler Bay, Florida, United States

Hillcrest Medical Research, LLC

DeLand, Florida, United States

North Florida Foundation for Research and Education

Gainesville, Florida, United States

Direct Helper Research Center

Hialeah, Florida, United States

Homestead Associates in Research Inc.

Homestead, Florida, United States

AppleMed Research Group, LLC

Miami, Florida, United States

Y&L Advanced Health Care, Inc.

Miami, Florida, United States

Reliant Medical Research LLC

Miami, Florida, United States

Valencia Medical & Research Center

Miami, Florida, United States

De La Cruz Research Center, LLC

Miami, Florida, United States

Coral Research Clinic Corporation

Miami, Florida, United States

Pro-Care Research Center, Corp.

Miami Gardens, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Florida Institute for Clinical Research

Orlando, Florida, United States

Sarasota Clinical Research

Sarasota, Florida, United States

TBC Research

Tamarac, Florida, United States

Clinical Research of West Florida - Tampa

Tampa, Florida, United States

Appalachian Clinical Research, LLC

Adairsville, Georgia, United States

Pulmonology, Sleep, Asthma, and Allergy Center - Dublin

Dublin, Georgia, United States

CPCC - Research, LLC

East Point, Georgia, United States

Centricity Research

Rincon, Georgia, United States

Velocity Clinical Research - Boise

Meridian, Idaho, United States

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, United States

Indiana Medical Research Institute

Merrillville, Indiana, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

The Research Group of Lexington, LLC

Lexington, Kentucky, United States

Tandem Clinical Research

Metairie, Louisiana, United States

Care Access - Shreveport

Shreveport, Louisiana, United States

Mayflower Clinical

South Dartmouth, Massachusetts, United States

Revival Research Institute, LLC

Dearborn, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Pulmonary Research Institute of SE Michigan

Farmington Hills, Michigan, United States

Revive Research Institute

Southfield, Michigan, United States

Midwest Chest Consultants

Saint Charles, Missouri, United States

Montana Medical Research, Inc.

Missoula, Montana, United States

Henderson Trials

Henderson, Nevada, United States

Rutgers, The State University of New Jersy

New Brunswick, New Jersey, United States

Certified Research Associates Finger Lakes Medical Research, LLC

Cortland, New York, United States

Corning Center for Clinical Research Smith Allergy & Asthma Specialists

Horseheads, New York, United States

Northwell Health

New Hyde Park, New York, United States

OnSite Clinical Solutions

Charlotte, North Carolina, United States

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Triad Clinical Trials

Greensboro, North Carolina, United States

Peters Medical Research

High Point, North Carolina, United States

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, United States

Accellacare Wilmington

Wilmington, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Remington Davis

Columbus, Ohio, United States

NexGen Research

Lima, Ohio, United States

OK Clinical Research

Edmond, Oklahoma, United States

Velocity Clinical Research - Grants Pass

Grants Pass, Oregon, United States

Velocity Clinical Research - Medford

Medford, Oregon, United States

Clinical Research Associates of Central PA

DuBois, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh/UPMC

Pittsburgh, Pennsylvania, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

Velocity Clinical Research - Anderson

Anderson, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Velocity Clinical Research - Columbia

Columbia, South Carolina, United States

Velocity Clinical Research - Gaffney

Gaffney, South Carolina, United States

Velocity Clinical Research - Greenville

Greenville, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

Velocity Clinical Research - Union

Union, South Carolina, United States

Pulmonary & Sleep Specialists

Dickson, Tennessee, United States

Premier Research Center, LLC

Hendersonville, Tennessee, United States

New Phase Research & Development

Knoxville, Tennessee, United States

TTS Research

Boerne, Texas, United States

Proactive RGV

Brownsville, Texas, United States

Ten20 Clinical Research, LLC

Carrollton, Texas, United States

IntraCare Health Center

Dallas, Texas, United States

IntraCare Clinical

Greenville, Texas, United States

Axsendo Clinical Research

Houston, Texas, United States

Gulf Coast Clinical Research

Houston, Texas, United States

R & H Clinical Research

Katy, Texas, United States

IntraCare Health Center

McKinney, Texas, United States

SMS Clinical Research

Mesquite, Texas, United States

ADP Clinical Research

Splendora, Texas, United States

Alpine Research Organization, Inc.

Layton, Utah, United States

Velocity Clinical Research - Hampton

Hampton, Virginia, United States

Core Clinical

Everett, Washington, United States

Confluence Health

Wenatchee, Washington, United States

Momentum Taringa

Taringa, Brisbane, Australia

Northside Health

Coffs Harbour, New South Wales, Australia

Momentum St. Leonards

Sydney, New South Wales, Australia

Momentum Wellers Hill

Tarragindi, Queensland, Australia

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, Canada

Pacific Clinical Research Network Auckland - PCRN West Auckland

New Lynn, Auckland, New Zealand

Momentum Wellington

Mount Cook, Wellington Region, New Zealand

Pacific Clinical Research Network Auckland - PCRN Auckland

Auckland, New Zealand

New Zealand Respiratory & Sleep Institute (NZRSI)

Auckland, New Zealand

Momentum Hawke's Bay

Hastings, New Zealand

Momentum Tauranga

Tauranga, New Zealand

Momentum Kapiti

Waikanae, New Zealand

The Medicines Evaluation Unit, an IQVIA business

Wythenshawe, Manchester, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

Velocity Clinical Research High Wycombe

High Wycombe, United Kingdom

Velocity Clinical Research - Bristol

London, United Kingdom

Queen Anne Street Medical Centre

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06496620


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