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New biologic drug solrikitug aims to tame COPD inflammation

NCT ID NCT06496620

Disease control Sponsor: Uniquity One (UNI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This Phase 2 trial tests solrikitug, a biologic drug given as a shot, in 171 adults with moderate-to-severe COPD and high eosinophil levels. The study compares two doses of solrikitug against a placebo to see if it safely reduces inflammation and improves lung function over time. Researchers will measure changes in blood eosinophil counts and breathing tests to determine if the drug helps control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Solrikitug (a biologic drug given as a shot under the skin)
What this could lead to
If it works, solrikitug could become a new treatment option to help control COPD by reducing inflammation and improving lung function.
What could go wrong
This is an early Phase 2 trial with only 171 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

182 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD

Contacts and locations

Locations

  • ADP Clinical Research

    Splendora, Texas, 77372, United States

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401, United States

  • Access Research Institute

    Brooksville, Florida, 34613, United States

  • Advanced Respiratory and Sleep Medicine

    Huntersville, North Carolina, 28078, United States

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85281, United States

  • Alpine Research Organization, Inc.

    Layton, Utah, 84041, United States

  • AnMed Health

    Anderson, South Carolina, 29621, United States

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534, United States

  • Appalachian Clinical Research, LLC

    Adairsville, Georgia, 30103, United States

  • AppleMed Research Group, LLC

    Miami, Florida, 33126, United States

  • Ark Clinical Research - Ballinger

    Long Beach, California, 90815, United States

  • Axsendo Clinical Research

    Houston, Texas, 77030, United States

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, BD9 6RJ, United Kingdom

  • CPCC - Research, LLC

    East Point, Georgia, 30344, United States

  • Care Access - Shreveport

    Shreveport, Louisiana, 71105, United States

  • Centricity Research

    Rincon, Georgia, 31326, United States

  • Certified Research Associates Finger Lakes Medical Research, LLC

    Cortland, New York, 13045, United States

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801, United States

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054, United States

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Clinical Research of West Florida - Clearwater

    Clearwater, Florida, 33765, United States

  • Clinical Research of West Florida - Tampa

    Tampa, Florida, 33606, United States

  • Coral Research Clinic Corporation

    Miami, Florida, 33186, United States

  • Corning Center for Clinical Research Smith Allergy & Asthma Specialists

    Horseheads, New York, 14845, United States

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184, United States

  • Direct Helper Research Center

    Hialeah, Florida, 33012, United States

  • Downtown LA Research Center, Inc.

    Los Angeles, California, 90017, United States

  • Epic Medical Research-Surprise

    Sun City, Arizona, 85351, United States

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825, United States

  • Gulf Coast Clinical Research

    Houston, Texas, 77070, United States

  • Henderson Trials

    Henderson, Nevada, 89052, United States

  • Henry Ford Health System

    Detroit, Michigan, 48207, United States

  • Hillcrest Medical Research, LLC

    DeLand, Florida, 32720, United States

  • Homestead Associates in Research Inc.

    Homestead, Florida, 33033, United States

  • Indiana Medical Research Institute

    Merrillville, Indiana, 46410, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • IntraCare Clinical

    Greenville, Texas, 75401, United States

  • IntraCare Health Center

    Dallas, Texas, 75254, United States

  • IntraCare Health Center

    McKinney, Texas, 75071, United States

  • JY Research Institute

    Cutler Bay, Florida, 33189, United States

  • Mayflower Clinical

    South Dartmouth, Massachusetts, 02747, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29245, United States

  • Midwest Chest Consultants

    Saint Charles, Missouri, 63301, United States

  • Momentum Hawke's Bay

    Hastings, 4122, New Zealand

  • Momentum Kapiti

    Waikanae, 5036, New Zealand

  • Momentum St. Leonards

    Sydney, New South Wales, 2065, Australia

  • Momentum Taringa

    Taringa, Brisbane, QLD 4068, Australia

  • Momentum Tauranga

    Tauranga, 3110, New Zealand

  • Momentum Wellers Hill

    Tarragindi, Queensland, 4121, Australia

  • Momentum Wellington

    Mount Cook, Wellington Region, 6021, New Zealand

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808, United States

  • New Phase Research & Development

    Knoxville, Tennessee, 37909, United States

  • New Zealand Respiratory & Sleep Institute (NZRSI)

    Auckland, 1051, New Zealand

  • Newport Native MD, Inc.

    Newport Beach, California, 92663, United States

  • NexGen Research

    Lima, Ohio, 45801, United States

  • Northside Health

    Coffs Harbour, New South Wales, 2450, Australia

  • Novak Clinical Research

    Tucson, Arizona, 85741, United States

  • OK Clinical Research

    Edmond, Oklahoma, 73034, United States

  • OM Research

    Oxnard, California, 93036, United States

  • OSF HealthCare Saint Francis Medical Center

    Peoria, Illinois, 61606, United States

  • OnSite Clinical Solutions

    Charlotte, North Carolina, 28277, United States

  • Pacific Clinical Research Network Auckland - PCRN Auckland

    Auckland, 1024, New Zealand

  • Pacific Clinical Research Network Auckland - PCRN West Auckland

    New Lynn, Auckland, 0600, New Zealand

  • Peters Medical Research

    High Point, North Carolina, 27260, United States

  • Phoenix Medical Group

    Peoria, Arizona, 85381, United States

  • Premier Research Center, LLC

    Hendersonville, Tennessee, 37075, United States

  • Pro-Care Research Center, Corp.

    Miami Gardens, Florida, 33014, United States

  • Proactive RGV

    Brownsville, Texas, 78520, United States

  • Prospective Research Innovations, Inc.

    Rancho Cucamonga, California, 91730, United States

  • Pulmonary & Sleep Specialists

    Dickson, Tennessee, 37055, United States

  • Pulmonary Research Institute of SE Michigan

    Farmington Hills, Michigan, 48336, United States

  • Pulmonology, Sleep, Asthma, and Allergy Center - Dublin

    Dublin, Georgia, 31021, United States

  • Queen Anne Street Medical Centre

    London, W1T 6AH, United Kingdom

  • R & H Clinical Research

    Katy, Texas, 77494, United States

  • Reliant Medical Research LLC

    Miami, Florida, 33165, United States

  • Remington Davis

    Columbus, Ohio, 43215, United States

  • Revival Research Institute, LLC

    Dearborn, Michigan, 48126, United States

  • Revive Research Institute

    Southfield, Michigan, 48075, United States

  • Rutgers, The State University of New Jersy

    New Brunswick, New Jersey, 08901, United States

  • SMS Clinical Research

    Mesquite, Texas, 75149, United States

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014, United States

  • Sarasota Clinical Research

    Sarasota, Florida, 34239, United States

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • Syed Research Consultants

    Sheffield, Alabama, 35660, United States

  • TBC Research

    Tamarac, Florida, 33321, United States

  • TTS Research

    Boerne, Texas, 78006, United States

  • Tandem Clinical Research

    Metairie, Louisiana, 70006, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Ten20 Clinical Research, LLC

    Carrollton, Texas, 75010, United States

  • The Medicines Evaluation Unit, an IQVIA business

    Wythenshawe, Manchester, M23 9QZGB, United Kingdom

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503, United States

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410, United States

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35294, United States

  • University of Pittsburgh/UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Valencia Medical & Research Center

    Miami, Florida, 33174, United States

  • Velocity Clinical Research - Anderson

    Anderson, South Carolina, 29621, United States

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Bristol

    London, N12 8BU, United Kingdom

  • Velocity Clinical Research - Columbia

    Columbia, South Carolina, 29204, United States

  • Velocity Clinical Research - Denver

    Englewood, Colorado, 80110, United States

  • Velocity Clinical Research - Gaffney

    Gaffney, South Carolina, 29340, United States

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon, 97257, United States

  • Velocity Clinical Research - Greenville

    Greenville, South Carolina, 29615, United States

  • Velocity Clinical Research - Hampton

    Hampton, Virginia, 23666, United States

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29303, United States

  • Velocity Clinical Research - Union

    Union, South Carolina, 29379, United States

  • Velocity Clinical Research High Wycombe

    High Wycombe, HP11 2QW, United Kingdom

  • Y&L Advanced Health Care, Inc.

    Miami, Florida, 33144, United States

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