A Study to Evaluate Solrikitug in Participants With COPD (ZION)
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
Interventions
Biological: Solrikitug low dose
Biological: Solrikitug high dose
Placebo
Conditions
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