AsthmaPhase 2RAINIERNCT06496607
A Study to Evaluate Solriktug in Adult Participants With Asthma
A Phase 2 study testing NSI-8226 in people with Asthma, run by Uniquity One (UNI) at 69 sites in United States.
Trial summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- NSI-8226
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 69 sitesUnited States
- Study dates
- 26 Jul 2024to 26 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be aged 18 to 75 years of age.
- Documented diagnosis of asthma at least 12 months prior to Screening.
- Participants must be on maintenance asthma medications, for at least 3 months prior to screening: inhaled corticosteroid (ICS) in combination with long-acting beta agonist (LABA), or as part of an approved triple therapy for asthma (ICS/LABA/long-acting muscarinic antagonist [LAMA]).
- Participant has an ACQ-6 score ≥1.5 at Screening Visit.
- Participant has FEV1 of ≥50% to 90%, inclusive, of predicted normal value at Screening Visit 1.
- Evidence of asthma as documented by reversibility in FEV1 of ≥12% and ≥200 mL over the pre-salbutamol FEV1 at Screening Visit.
Who cannot join
- Female participant who is pregnant or breastfeeding.
- Participant is a current smoker, or former smoker with a smoking history of ≥10 pack-years.
- 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 (risks factors of pneumonia) that in the opinion of the Investigator might obfuscate the study data.
- Participant has an exacerbation of asthma requiring use of OCS or hospitalization in the 6 weeks prior to Screening or during the Screening Period.
- Participant has history or evidence of any clinically significant pulmonary condition, other than asthma.
- Lower respiratory tract infection within the 6 weeks prior to Screening.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Asheville Clinical Research
Asheville, North Carolina, 28803
TTS Research
Boerne, Texas, 78006
NexGen Research
Boise, Idaho, 83706
Treasure Valley Medical Research
Boise, Idaho, 83706
Proactive RGV
Brownsville, Texas, 78520
Ten20 Clinical Research, LLC
Carrollton, Texas, 75010
Javarra Research
Conroe, Texas, 77384
National Clinical Trials
Cordele, Georgia, 31015
JY Research Institute
Cutler Bay, Florida, 33189
Dallas Allergy and Asthma Center
Dallas, Texas, 75231
IntraCare Health Center
Dallas, Texas, 75254
Midwest Clinical Research
Dayton, Ohio, 45417
Deerborn Clinic
Dearborn, Michigan, 48126
Hillcrest Medical Research, LLC
DeLand, Florida, 32720
Henry Ford Health System
Detroit, Michigan, 48202
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
CPCC - Research, LLC
East Point, Georgia, 30344
OK Clinical Research
Edmond, Oklahoma, 73034
Warren W. Pleskow, M.D.
Encinitas, California, 92024
Velocity Clinical Research - Denver
Englewood, Colorado, 80110
Pulmonary Research Institute of SE Michigan
Farmington Hills, Michigan, 48336
US Allergy & Asthma
Frisco, Texas, 75035
IntraCare Clinical
Greenville, Texas, 75401
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666
Henderson Trials
Henderson, Nevada, 89052
Premier Research Center, LLC
Hendersonville, Tennessee, 37075
Axsendo Clinical Research
Houston, Texas, 77002
Gulf Coast Clinical Research
Houston, Texas, 77070
Beach Physicians Clinical Research Corp.
Huntington Beach, California, 92647
New Phase Research & Development
Knoxville, Tennessee, 37909
Biosolutions Clinical Research Center
La Mesa, California, 91942
Velocity Clinical Research
Lafayette, Louisiana, 70508
Allergy & Asthma Diagnostic Treatment Center
Lancaster, Pennsylvania, 17601
Clinical Site Partners LLC dba-Leesburg
Leesburg, Florida, 34748
Orso Health
Long Beach, California, 90808
Downtown LA Research Center
Los Angeles, California, 90017
Care Access - Mauldin
Mauldin, South Carolina, 29662
Velocity Clinical Research
Medford, Oregon, 97504
Pharmax Research of South Florida
Miami, Florida, 33126
Coral Research Clinic Corp.
Miami, Florida, 33186
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014
Montana Medical Research, Inc.
Missoula, Montana, 59808
Velocity Clinical Research
Mobile, Alabama, 36608
Allergy, Asthma & Sinus Center, LLC
Myrtle Beach, South Carolina, 29588
Newport Native MD, Inc.
Newport Beach, California, 92663
MBR - Charleston
North Charleston, South Carolina, 29406
Phoenix Medical Group
Peoria, Arizona, 85381
Temple University - Shenoy
Philadelphia, Pennsylvania, 19140
Northwest Research Center
Portland, Oregon, 97202
A1 Clinical
Queens Village, New York, 11428
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, 95117
San Jose Clinical Trials
San Jose, California, 95128
North Bay Clinical Research
Santa Rosa, California, 95405
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406
Velocity Clinical Research - Sioux City
Sioux City, Iowa, 51106
Mayflower Clinical
South Dartmouth, Massachusetts, 02747
Revive Research Institute, Inc.
Southfield, Michigan, 48075
Ogden Clinical Canyon View
Tallahassee, Florida, 32308
Care Access, Tamarac
Tamarac, Florida, 33321
TBC Research
Tamarac, Florida, 33321
Toledo Institute of Clinical Research Inc.
Toledo, Ohio, 43617
Providere Research
West Covina, California, 91790
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
Accellacare - Duly
Winfield, Illinois, 60190
Southeastern Research Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Adult Participants With Asthma (RAINIER)
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Read the detailed description
This is a 12-week randomized, double-blind, placebo-controlled Phase 2 clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with asthma.
Approximately 140 adult participants with asthma will be randomized. 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
- Asthma
- Being tested
- NSI-8226, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSI-8226Biological
Solrikitug
NSI-8226Biological
Solrikitug
NSI-8226Biological
Solrikitug
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Solrikitug low dose subcutaneous injection | Experimental | Solrikitug Receives: Biological: NSI-8226 |
| Solrikitug mid dose subcutaneous injection | Experimental | Solrikitug Receives: Biological: NSI-8226 |
| Solrikitug high dose subcutaneous injection | Experimental | Solrikitug Receives: Biological: NSI-8226 |
| Placebo subcutaneous injection | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Change from baseline in blood eosinophil counts evaluated over Weeks 8 to 12
Measured: Over weeks 8 and 12
Secondary outcomes (1)
To assess the safety and tolerability of multiple doses of solrikitug
Adverse events (AEs) and serious adverse events (SAEs)
Measured: To week 12
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 start26 Jul 2024
- Primary completion6 Jul 2026
- Study completion26 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 145 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
- NCT06496607
- Sponsor's protocol ID
- NSI-8226-204
- Acronym
- RAINIER
- 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 Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Adult Participants With Asthma (RAINIER)
- ClinicalTrials.gov ID
- NCT06496607
- Acronym / sponsor ID
- RAINIER / NSI-8226-204
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Uniquity One (UNI)Industry (pharma, biotech, devices)
- Collaborators
- DevPro Biopharma
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 26 Oct 2026 (actual)
- 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.
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Detailed description
This is a 12-week randomized, double-blind, placebo-controlled Phase 2 clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with asthma.
Approximately 140 adult participants with asthma will be randomized. 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Solrikitug low dose subcutaneous injection | Experimental | Biological: NSI-8226Solrikitug |
| Solrikitug mid dose subcutaneous injection | Experimental | Biological: NSI-8226Solrikitug |
| Solrikitug high dose subcutaneous injection | Experimental | Biological: NSI-8226Solrikitug |
| Placebo subcutaneous injection | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be aged 18 to 75 years of age.
- Documented diagnosis of asthma at least 12 months prior to Screening.
- Participants must be on maintenance asthma medications, for at least 3 months prior to screening: inhaled corticosteroid (ICS) in combination with long-acting beta agonist (LABA), or as part of an approved triple therapy for asthma (ICS/LABA/long-acting muscarinic antagonist [LAMA]).
- Participant has an ACQ-6 score ≥1.5 at Screening Visit.
- Participant has FEV1 of ≥50% to 90%, inclusive, of predicted normal value at Screening Visit 1.
Key exclusion criteria (7 listed)
- Female participant who is pregnant or breastfeeding.
- Participant is a current smoker, or former smoker with a smoking history of ≥10 pack-years.
- 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 (risks factors of pneumonia) that in the opinion of the Investigator might obfuscate the study data.
- Participant has an exacerbation of asthma requiring use of OCS or hospitalization in the 6 weeks prior to Screening or during the Screening Period.
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 |
|---|---|---|
| NSI-8226Solrikitug | Biological | Solrikitug low dose subcutaneous injection |
| NSI-8226Solrikitug | Biological | Solrikitug mid dose subcutaneous injection |
| NSI-8226Solrikitug | Biological | Solrikitug high dose subcutaneous injection |
| PlaceboPlacebo | Biological | Placebo subcutaneous injection |
Primary outcome
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Time frame: Over weeks 8 and 12
Change from baseline in blood eosinophil counts evaluated over Weeks 8 to 12
1 secondary outcome
To assess the safety and tolerability of multiple doses of solrikitug
Time frame: To week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NSI-8226 in people with Asthma, run by Uniquity One (UNI) at 69 sites in United States.
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 6 inclusion and 7 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: finished, 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 69 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo (time frame: Over weeks 8 and 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.