A Study to Evaluate Solriktug in Adult Participants With Asthma
RAINIER
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)
1 other identifier
interventional
145
1 country
69
Brief Summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Jul 2024
Typical duration for phase_2 asthma
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedStudy Start
First participant enrolled
July 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 1, 2026
April 1, 2026
1.9 years
July 3, 2024
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Over weeks 8 and 12
Secondary Outcomes (1)
To assess the safety and tolerability of multiple doses of solrikitug
To week 12
Study Arms (4)
Solrikitug low dose subcutaneous injection
EXPERIMENTALSolrikitug
Solrikitug mid dose subcutaneous injection
EXPERIMENTALSolrikitug
Solrikitug high dose subcutaneous injection
EXPERIMENTALSolrikitug
Placebo subcutaneous injection
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uniquity One (UNI)lead
- DevPro Biopharmacollaborator
Study Sites (69)
Velocity Clinical Research
Mobile, Alabama, 36608, United States
Phoenix Medical Group
Peoria, Arizona, 85381, United States
Warren W. Pleskow, M.D.
Encinitas, California, 92024, United States
Beach Physicians Clinical Research Corp.
Huntington Beach, California, 92647, United States
Biosolutions Clinical Research Center
La Mesa, California, 91942, United States
Orso Health
Long Beach, California, 90808, United States
Downtown LA Research Center
Los Angeles, California, 90017, United States
Newport Native MD, Inc.
Newport Beach, California, 92663, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, 95117, United States
San Jose Clinical Trials
San Jose, California, 95128, United States
North Bay Clinical Research
Santa Rosa, California, 95405, United States
Providere Research
West Covina, California, 91790, United States
Velocity Clinical Research - Denver
Englewood, Colorado, 80110, United States
JY Research Institute
Cutler Bay, Florida, 33189, United States
Hillcrest Medical Research, LLC
DeLand, Florida, 32720, United States
Clinical Site Partners LLC dba-Leesburg
Leesburg, Florida, 34748, United States
Pharmax Research of South Florida
Miami, Florida, 33126, United States
Coral Research Clinic Corp.
Miami, Florida, 33186, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014, United States
Ogden Clinical Canyon View
Tallahassee, Florida, 32308, United States
Care Access, Tamarac
Tamarac, Florida, 33321, United States
TBC Research
Tamarac, Florida, 33321, United States
National Clinical Trials
Cordele, Georgia, 31015, United States
CPCC - Research, LLC
East Point, Georgia, 30344, United States
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406, United States
NexGen Research
Boise, Idaho, 83706, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Accellacare - Duly
Winfield, Illinois, 60190, United States
Velocity Clinical Research - Sioux City
Sioux City, Iowa, 51106, United States
Velocity Clinical Research
Lafayette, Louisiana, 70508, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162, United States
Mayflower Clinical
South Dartmouth, Massachusetts, 02747, United States
Deerborn Clinic
Dearborn, Michigan, 48126, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Pulmonary Research Institute of SE Michigan
Farmington Hills, Michigan, 48336, United States
Revive Research Institute, Inc.
Southfield, Michigan, 48075, United States
Montana Medical Research, Inc.
Missoula, Montana, 59808, United States
Henderson Trials
Henderson, Nevada, 89052, United States
A1 Clinical
Queens Village, New York, 11428, United States
Asheville Clinical Research
Asheville, North Carolina, 28803, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
Midwest Clinical Research
Dayton, Ohio, 45417, United States
Toledo Institute of Clinical Research Inc.
Toledo, Ohio, 43617, United States
OK Clinical Research
Edmond, Oklahoma, 73034, United States
Velocity Clinical Research
Medford, Oregon, 97504, United States
Northwest Research Center
Portland, Oregon, 97202, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801, United States
Allergy & Asthma Diagnostic Treatment Center
Lancaster, Pennsylvania, 17601, United States
Temple University - Shenoy
Philadelphia, Pennsylvania, 19140, United States
Care Access - Mauldin
Mauldin, South Carolina, 29662, United States
Allergy, Asthma & Sinus Center, LLC
Myrtle Beach, South Carolina, 29588, United States
MBR - Charleston
North Charleston, South Carolina, 29406, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732, 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
Javarra Research
Conroe, Texas, 77384, United States
Dallas Allergy and Asthma Center
Dallas, Texas, 75231, United States
IntraCare Health Center
Dallas, Texas, 75254, United States
US Allergy & Asthma
Frisco, Texas, 75035, United States
IntraCare Clinical
Greenville, Texas, 75401, United States
Axsendo Clinical Research
Houston, Texas, 77002, United States
Gulf Coast Clinical Research
Houston, Texas, 77070, United States
Velocity Clinical Research - Hampton
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrew W Lee, MD
Vice President, Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 11, 2024
Study Start
July 26, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04