COPDPhase 2ZIONNCT06496620
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
A Phase 2 study testing Biological: Solrikitug low dose and Biological: Solrikitug high dose in people with COPD, run by Uniquity One (UNI) at 110 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Biological: Solrikitug low dose and Biological: Solrikitug high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 110 sitesin 4 countries
- Study dates
- 14 Aug 2024to 1 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
110 sites in 4 countries.
110 sites in 4 countries
United States94 sites
Appalachian Clinical Research, LLC
Adairsville, Georgia, 30103
AnMed Health
Anderson, South Carolina, 29621
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294
TTS Research
Boerne, Texas, 78006
Access Research Institute
Brooksville, Florida, 34613
Proactive RGV
Brownsville, Texas, 78520
Ten20 Clinical Research, LLC
Carrollton, Texas, 75010
Medical University of South Carolina
Charleston, South Carolina, 29245
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Clinical Research of West Florida - Clearwater
Clearwater, Florida, 33765
Velocity Clinical Research - Columbia
Columbia, South Carolina, 29204
Remington Davis
Columbus, Ohio, 43215
Certified Research Associates Finger Lakes Medical Research, LLC
Cortland, New York, 13045
JY Research Institute
Cutler Bay, Florida, 33189
IntraCare Health Center
Dallas, Texas, 75254
Revival Research Institute, LLC
Dearborn, Michigan, 48126
Hillcrest Medical Research, LLC
DeLand, Florida, 32720
Henry Ford Health System
Detroit, Michigan, 48207
Pulmonary & Sleep Specialists
Dickson, Tennessee, 37055
Pulmonology, Sleep, Asthma, and Allergy Center - Dublin
Dublin, Georgia, 31021
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
CPCC - Research, LLC
East Point, Georgia, 30344
OK Clinical Research
Edmond, Oklahoma, 73034
Velocity Clinical Research - Denver
Englewood, Colorado, 80110
Pulmonary Research Institute of SE Michigan
Farmington Hills, Michigan, 48336
Velocity Clinical Research - Gaffney
Gaffney, South Carolina, 29340
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97257
Triad Clinical Trials
Greensboro, North Carolina, 27410
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615
IntraCare Clinical
Greenville, Texas, 75401
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666
Henderson Trials
Henderson, Nevada, 89052
Premier Research Center, LLC
Hendersonville, Tennessee, 37075
Direct Helper Research Center
Hialeah, Florida, 33012
Peters Medical Research
High Point, North Carolina, 27260
Homestead Associates in Research Inc.
Homestead, Florida, 33033
Corning Center for Clinical Research Smith Allergy & Asthma Specialists
Horseheads, New York, 14845
Axsendo Clinical Research
Houston, Texas, 77030
Gulf Coast Clinical Research
Houston, Texas, 77070
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078
R & H Clinical Research
Katy, Texas, 77494
New Phase Research & Development
Knoxville, Tennessee, 37909
Antelope Valley Clinical Trials
Lancaster, California, 93534
Alpine Research Organization, Inc.
Layton, Utah, 84041
The Research Group of Lexington, LLC
Lexington, Kentucky, 40503
NexGen Research
Lima, Ohio, 45801
Ark Clinical Research - Ballinger
Long Beach, California, 90815
Downtown LA Research Center, Inc.
Los Angeles, California, 90017
IntraCare Health Center
McKinney, Texas, 75071
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Indiana Medical Research Institute
Merrillville, Indiana, 46410
SMS Clinical Research
Mesquite, Texas, 75149
Tandem Clinical Research
Metairie, Louisiana, 70006
AppleMed Research Group, LLC
Miami, Florida, 33126
Y&L Advanced Health Care, Inc.
Miami, Florida, 33144
Reliant Medical Research LLC
Miami, Florida, 33165
Valencia Medical & Research Center
Miami, Florida, 33174
De La Cruz Research Center, LLC
Miami, Florida, 33184
Coral Research Clinic Corporation
Miami, Florida, 33186
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Montana Medical Research, Inc.
Missoula, Montana, 59808
Rutgers, The State University of New Jersy
New Brunswick, New Jersey, 08901
Newport Native MD, Inc.
Newport Beach, California, 92663
Florida Institute for Clinical Research
Orlando, Florida, 32825
OM Research
Oxnard, California, 93036
Phoenix Medical Group
Peoria, Arizona, 85381
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61606
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh/UPMC
Pittsburgh, Pennsylvania, 15213
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Prospective Research Innovations, Inc.
Rancho Cucamonga, California, 91730
Centricity Research
Rincon, Georgia, 31326
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Midwest Chest Consultants
Saint Charles, Missouri, 63301
Sarasota Clinical Research
Sarasota, Florida, 34239
Syed Research Consultants
Sheffield, Alabama, 35660
Care Access - Shreveport
Shreveport, Louisiana, 71105
Mayflower Clinical
South Dartmouth, Massachusetts, 02747
Revive Research Institute
Southfield, Michigan, 48075
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303
ADP Clinical Research
Splendora, Texas, 77372
Epic Medical Research-Surprise
Sun City, Arizona, 85351
TBC Research
Tamarac, Florida, 33321
Clinical Research of West Florida - Tampa
Tampa, Florida, 33606
Alliance for Multispecialty Research
Tempe, Arizona, 85281
Novak Clinical Research
Tucson, Arizona, 85741
Velocity Clinical Research - Union
Union, South Carolina, 29379
Accellacare Wilmington
Wilmington, North Carolina, 28401
Southeastern Research Center
Winston-Salem, North Carolina, 27103
New Zealand7 sites
Pacific Clinical Research Network Auckland - PCRN Auckland
Auckland, 1024
New Zealand Respiratory & Sleep Institute (NZRSI)
Auckland, 1051
Momentum Hawke's Bay
Hastings, 4122
Momentum Wellington
Mount Cook, Wellington Region, 6021
Pacific Clinical Research Network Auckland - PCRN West Auckland
New Lynn, Auckland, 0600
Momentum Tauranga
Tauranga, 3110
Momentum Kapiti
Waikanae, 5036
United Kingdom5 sites
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
Velocity Clinical Research High Wycombe
High Wycombe, HP11 2QW
Velocity Clinical Research - Bristol
London, N12 8BU
Queen Anne Street Medical Centre
London, W1T 6AH
The Medicines Evaluation Unit, an IQVIA business
Wythenshawe, Manchester, M23 9QZGB
Australia4 sites
Northside Health
Coffs Harbour, New South Wales, 2450
Momentum St. Leonards
Sydney, New South Wales, 2065
Momentum Taringa
Taringa, Brisbane, QLD 4068
Momentum Wellers Hill
Tarragindi, Queensland, 4121
About this study
Official title: 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)
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).
Read the 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.
- Conditions
- COPD
- Being tested
- Biological: Solrikitug low dose, Biological: Solrikitug high dose, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: Solrikitug low doseBiological
Solrikitug subcutaneous injection
Biological: Solrikitug high doseBiological
Solrikitug subcutaneous injection
PlaceboOther
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Biological: Solrikitug High Dose | Experimental | Solrikitug Receives: Biological: Biological: Solrikitug high dose |
| Placebo | Other | Placebo Receives: Other: Placebo |
| Biological: Solrikitug Low Dose | Experimental | Solrikitug Receives: Biological: Biological: Solrikitug low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood eosinophil counts
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Measured: Through week 12
Secondary outcomes (1)
Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of multiple doses of solrikitug
Measured: Through week 12 To week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start14 Aug 2024
- Primary completion23 Sep 2026
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniquity One (UNI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DevPro Biopharma
- Responsible party
- Sponsor
- Investigators
- Andrew W Lee, MD, Study director, Vice President, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496620
- Sponsor's protocol ID
- NSI-8226-205
- Acronym
- ZION
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06496620
- Acronym / sponsor ID
- ZION / NSI-8226-205
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Uniquity One (UNI)Industry (pharma, biotech, devices)
- Collaborators
- DevPro Biopharma
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biological: Solrikitug High Dose | Experimental | Biological: Biological: Solrikitug high doseSolrikitug |
| Placebo | Other | Other: PlaceboPlacebo |
| Biological: Solrikitug Low Dose | Experimental | Biological: Biological: Solrikitug low doseSolrikitug |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: Solrikitug low doseSolrikitug subcutaneous injection | Biological | Biological: Solrikitug Low Dose |
| Biological: Solrikitug high doseSolrikitug subcutaneous injection | Biological | Biological: Solrikitug High Dose |
| PlaceboPlacebo subcutaneous injection | Other | Placebo |
Primary outcome
Change from baseline in blood eosinophil counts
Time frame: Through week 12
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
1 secondary outcome
Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Through week 12 To week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew W Lee, MD study director
Vice President, Clinical Research
110 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological: Solrikitug low dose and Biological: Solrikitug high dose in people with COPD, run by Uniquity One (UNI) at 110 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, New Zealand, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood eosinophil counts (time frame: Through week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.