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

Last updated: January 12, 2026
Sponsor: Uniquity One (UNI)
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Biological: Solrikitug low dose

Placebo

Biological: Solrikitug high dose

Clinical Study ID

NCT06496620
NSI-8226-205
  • Ages 40-75
  • All Genders

Study 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 Criteria

Inclusion

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 bythe 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 oftheir COPD, for at least 3 months prior to screening.

Exclusion

Exclusion Criteria:

  • Female participant who is pregnant or breastfeeding.

  • Participant has a known hypersensitivity to any component of the formulation ofsolrikitug, including any of the excipients, or a history of anaphylactic reactionto 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 conditionthat in the opinion of the Investigator or Medical Monitor might obfuscate the studydata.

  • Any other pulmonary disease than COPD that in the opinion of the Investigator, theseverity 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 Design

Total Participants: 171
Treatment Group(s): 5
Primary Treatment: Biological: Solrikitug low dose
Phase: 2
Study Start date:
August 14, 2024
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Research Site 090

    Tarragindi 2147336, Queensland 2152274 4121
    Australia

    Active - Recruiting

  • Research Site 094

    Waikanae 2180320, 5036
    New Zealand

    Active - Recruiting

  • Research Site 096

    High Wycombe 2646914, HP11 2QW
    United Kingdom

    Active - Recruiting

  • Research Site 034

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Active - Recruiting

  • Research Site 051

    Surprise, Arizona 85378
    United States

    Site Not Available

  • Research Site 033

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Research Site 099

    Peoria 5308480, Arizona 5551752 85381
    United States

    Active - Recruiting

  • Research Site 051

    Sun City 5316201, Arizona 5551752 85351
    United States

    Active - Recruiting

  • Research Site 051

    Surprise 5316428, Arizona 5551752 85378
    United States

    Site Not Available

  • Research Site 033

    Tempe 5317058, Arizona 5551752 85281
    United States

    Active - Recruiting

  • Research Site 095

    Tucson 5318313, Arizona 5551752 85741
    United States

    Active - Recruiting

  • Research Site 031

    Lancaster, California 93534
    United States

    Site Not Available

  • Research Site 032

    Los Angeles, California 90017
    United States

    Site Not Available

  • Research Site 018

    Newport Beach, California 92663
    United States

    Site Not Available

  • Research Site 041

    Oxnard, California 93036
    United States

    Site Not Available

  • Research Site 056

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Research Site 031

    Lancaster 5364940, California 5332921 93534
    United States

    Active - Recruiting

  • Research Site 107

    Long Beach 5367929, California 5332921 90815
    United States

    Active - Recruiting

  • Research Site 032

    Los Angeles 5368361, California 5332921 90017
    United States

    Active - Recruiting

  • Research Site 018

    Newport Beach 5376890, California 5332921 92663
    United States

    Active - Recruiting

  • Research Site 041

    Oxnard 5380184, California 5332921 93036
    United States

    Active - Recruiting

  • Research Site 056

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Active - Recruiting

  • Research Site 020

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Research Site 020

    Englewood 5421250, Colorado 5417618 80110
    United States

    Active - Recruiting

  • Research Site 002

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Research Site 049

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Research Site 035

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Research Site 064

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Research Site 057

    Homestead, Florida 33033
    United States

    Site Not Available

  • Research Site 004

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Research Site 052

    Miami, Florida 33184
    United States

    Active - Recruiting

  • Research Site 059

    Miami, Florida 33165
    United States

    Site Not Available

  • Research Site 038

    Miami Gardens, Florida 33014
    United States

    Site Not Available

  • Research Site 055

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Research Site 013

    Orlando, Florida 32825
    United States

    Site Not Available

  • Research Site 007

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Research Site 001

    Tampa, Florida 33606
    United States

    Site Not Available

  • Research Site 070

    Brooksville 4148986, Florida 4155751 34613
    United States

    Active - Recruiting

  • Research Site 002

    Clearwater 4151316, Florida 4155751 33765
    United States

    Active - Recruiting

  • Research Site 049

    Clearwater 4151316, Florida 4155751 33756
    United States

    Active - Recruiting

  • Research Site 035

    Cutler Bay 6332309, Florida 4155751 33189
    United States

    Active - Recruiting

  • Research Site 077

    DeLand 4152890, Florida 4155751 32720
    United States

    Active - Recruiting

  • Research Site 064

    Hialeah 4158476, Florida 4155751 33012
    United States

    Active - Recruiting

  • Research Site 057

    Homestead 4159050, Florida 4155751 33033
    United States

    Active - Recruiting

  • Research Site 004

    Miami 4164138, Florida 4155751 33186
    United States

    Active - Recruiting

  • Research Site 052

    Miami 4164138, Florida 4155751 33184
    United States

    Active - Recruiting

  • Research Site 059

    Miami 4164138, Florida 4155751 33165
    United States

    Active - Recruiting

  • Research Site 098

    Miami 4164138, Florida 4155751 33174
    United States

    Active - Recruiting

  • Research Site 101

    Miami 4164138, Florida 4155751 33144
    United States

    Active - Recruiting

  • Research Site 111

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Research Site 038

    Miami Gardens 4164167, Florida 4155751 33014
    United States

    Active - Recruiting

  • Research Site 055

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Active - Recruiting

  • Research Site 013

    Orlando 4167147, Florida 4155751 32825
    United States

    Active - Recruiting

  • Research Site 007

    Sarasota 4172131, Florida 4155751 34239
    United States

    Active - Recruiting

  • Research Site 067

    Tamarac 4174738, Florida 4155751 33321
    United States

    Active - Recruiting

  • Research Site 001

    Tampa 4174757, Florida 4155751 33606
    United States

    Active - Recruiting

  • Research Site 046

    Dublin, Georgia 31021
    United States

    Site Not Available

  • Research Site 003

    Rincon, Georgia 31326
    United States

    Site Not Available

  • Research Site 108

    Adairsville 4179094, Georgia 4197000 30103
    United States

    Active - Recruiting

  • Research Site 046

    Dublin 4192205, Georgia 4197000 31021
    United States

    Active - Recruiting

  • Research Site 110

    East Point 4192674, Georgia 4197000 30344
    United States

    Active - Recruiting

  • Research Site 003

    Rincon 4218882, Georgia 4197000 31326
    United States

    Active - Recruiting

  • Research Site 021

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Research Site 021

    Meridian 5600685, Idaho 5596512 83642
    United States

    Active - Recruiting

  • Research Site 079

    Peoria 4905687, Illinois 4896861 61606
    United States

    Active - Recruiting

  • Research Site 022

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • Research Site 022

    Merrillville 4923482, Indiana 4921868 46410
    United States

    Active - Recruiting

  • Research Site 042

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Research Site 042

    Lexington 4297983, Kentucky 6254925 40503
    United States

    Active - Recruiting

  • Research Site 026

    Metairie 4333177, Louisiana 4331987 70006
    United States

    Active - Recruiting

  • Research Site 097

    Shreveport 4341513, Louisiana 4331987 71105
    United States

    Active - Recruiting

  • Research Site 017

    Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Research Site 017

    South Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Research Site 017

    Russells Mills 4949233, Massachusetts 6254926 02747
    United States

    Site Not Available

  • Research Site 017

    South Dartmouth 4951356, Massachusetts 6254926 02747
    United States

    Active - Recruiting

  • Research Site 037

    Farmington Hills, Michigan 48336
    United States

    Site Not Available

  • Research Site 114

    Dearborn 4990510, Michigan 5001836 48126
    United States

    Active - Recruiting

  • Research Site 037

    Farmington Hills 4992523, Michigan 5001836 48336
    United States

    Active - Recruiting

  • Research Site 085

    Southfield 5010636, Michigan 5001836 48075
    United States

    Active - Recruiting

  • Research Site 009

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Research Site 009

    Saint Charles 4406831, Missouri 4398678 63301
    United States

    Site Not Available

  • Research Site 062

    Missoula, Montana 59808
    United States

    Site Not Available

  • Research Site 062

    Missoula 5666639, Montana 5667009 59808
    United States

    Active - Recruiting

  • Research Site 015

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Research Site 015

    Henderson 5505411, Nevada 5509151 89052
    United States

    Active - Recruiting

  • Research Site 044

    Cortland, New York 13045
    United States

    Site Not Available

  • Research Site 043

    Horseheads, New York 14845
    United States

    Site Not Available

  • Research 044

    Cortland 5113790, New York 5128638 13045
    United States

    Active - Recruiting

  • Research Site 044

    Cortland 5113790, New York 5128638 13045
    United States

    Active - Recruiting

  • Research Site 043

    Horseheads 5121309, New York 5128638 14845
    United States

    Active - Recruiting

  • Research Site 050

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Research Site 005

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Research Site 008

    High Point, North Carolina 27260
    United States

    Site Not Available

  • Research Site 039

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Research Site 006

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Research Site 014

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Research Site 050

    Charlotte 4460243, North Carolina 4482348 28277
    United States

    Active - Recruiting

  • Research Site 005

    Gastonia 4467732, North Carolina 4482348 28054
    United States

    Active - Recruiting

  • Research Site 104

    Greensboro 4469146, North Carolina 4482348 27410
    United States

    Active - Recruiting

  • Research Site 008

    High Point 4471025, North Carolina 4482348 27260
    United States

    Active - Recruiting

  • Research Site 039

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • Research Site 006

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Active - Recruiting

  • Research Site 014

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Active - Recruiting

  • Research Site 036

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Research Site 036

    Columbus 4509177, Ohio 5165418 43215
    United States

    Active - Recruiting

  • Research Site 086

    Lima 5160783, Ohio 5165418 45801
    United States

    Active - Recruiting

  • Research Site 115

    Edmond 4535740, Oklahoma 4544379 73034
    United States

    Active - Recruiting

  • Research Site 047

    Grants Pass, Oregon 97257
    United States

    Site Not Available

  • Research Site 011

    Medford, Oregon 97504
    United States

    Site Not Available

  • Research Site 047

    Grants Pass 5729080, Oregon 5744337 97257
    United States

    Active - Recruiting

  • Research Site 011

    Medford 5740099, Oregon 5744337 97504
    United States

    Active - Recruiting

  • Research Site 053

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Research Site 083

    DuBois 5187432, Pennsylvania 6254927 15801
    United States

    Active - Recruiting

  • Research Site 053

    Pittsburgh 5206379, Pennsylvania 6254927 15241
    United States

    Active - Recruiting

  • Research Site 023

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Research Site 028

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Research Site 027

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Research Site 010

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Research Site 024

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Research Site 029

    Union, South Carolina 29379
    United States

    Site Not Available

  • Research Site 023

    Anderson 4569298, South Carolina 4597040 29621
    United States

    Active - Recruiting

  • Research Site 028

    Columbia 4575352, South Carolina 4597040 29204
    United States

    Active - Recruiting

  • Research Site 030

    Gaffney 4579418, South Carolina 4597040 29340
    United States

    Active - Recruiting

  • Research Site 027

    Greenville 4580543, South Carolina 4597040 29615
    United States

    Active - Recruiting

  • Research Site 010

    Rock Hill 4593142, South Carolina 4597040 29732
    United States

    Active - Recruiting

  • Research Site 024

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

    Active - Recruiting

  • Research Site 029

    Union 4599214, South Carolina 4597040 29379
    United States

    Active - Recruiting

  • Research Site 040

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • Research Site 048

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Research Site 040

    Hendersonville 4628735, Tennessee 4662168 37075
    United States

    Active - Recruiting

  • Research Site 048

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Active - Recruiting

  • Research Site 016

    Boerne, Texas 78006
    United States

    Site Not Available

  • Research Site 025

    Houston, Texas 77070
    United States

    Active - Recruiting

  • Research Site 060

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site 012

    McKinney, Texas 75071
    United States

    Site Not Available

  • Research Site 016

    Boerne 4675373, Texas 4736286 78006
    United States

    Site Not Available

  • Research Site 076

    Brownsville 4676740, Texas 4736286 78520
    United States

    Active - Recruiting

  • Research Site 112

    Carrollton 4679195, Texas 4736286 75010
    United States

    Active - Recruiting

  • Research Site 012

    Dallas 4684888, Texas 4736286 75254
    United States

    Active - Recruiting

  • Research Site 089

    Greenville 4695066, Texas 4736286 75401
    United States

    Active - Recruiting

  • Research Site 025

    Houston 4699066, Texas 4736286 77070
    United States

    Active - Recruiting

  • Research Site 051

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Research Site 060

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Research Site 087

    Katy 4702732, Texas 4736286 77494
    United States

    Active - Recruiting

  • Research Site 012

    McKinney 4710178, Texas 4736286 75071
    United States

    Active - Recruiting

  • Research Site 084

    Mesquite 4710826, Texas 4736286 75149
    United States

    Active - Recruiting

  • Research Site 109

    Splendora 4733593, Texas 4736286 77372
    United States

    Active - Recruiting

  • Research Site 088

    Layton 5777107, Utah 5549030 84041
    United States

    Active - Recruiting

  • Research Site 019

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Research Site 019

    Hampton 4762894, Virginia 6254928 23666
    United States

    Active - Recruiting

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