TrialPath
← Back to searchRecruiting

A Study to Evaluate Solriktug in Adult Participants With Asthma

NCT06496607 · Uniquity One (UNI)
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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)
About this study
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.
Eligibility criteria
Key inclusion criteria: * 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. Key exclusion criteria: * 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.
Study design
Enrollment target: 140 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-07-26
Estimated completion: 2026-09-30
Last updated: 2026-02-27
Interventions
Biological: NSI-8226Biological: NSI-8226Biological: NSI-8226Biological: Placebo
Primary outcomes
  • To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo (Over weeks 8 and 12)
Sponsor
Uniquity One (UNI) · industry
With: DevPro Biopharma
Contacts & investigators
ContactUniquity One Clinical Trials · contact · ClinicalTrials@uniquity.com · 484-267-2500
ContactAnushri Walsh · contact · awalsh@devprobiopharma.com · 973-983-3700
InvestigatorAndrew W Lee, MD · study_director, Vice President, Clinical Research
All locations (74)
Velocity Clinical ResearchRecruiting
Mobile, Alabama, United States
Phoenix Medical GroupRecruiting
Peoria, Arizona, United States
Warren W. Pleskow, M.D.Recruiting
Encinitas, California, United States
Beach Physicians Clinical Research Corp.Recruiting
Huntington Beach, California, United States
Biosolutions Clinical Research CenterRecruiting
La Mesa, California, United States
Orso HealthRecruiting
Long Beach, California, United States
Downtown LA Research CenterRecruiting
Los Angeles, California, United States
Newport Native MD, Inc.Recruiting
Newport Beach, California, United States
Prospective Research Innovations Inc.Recruiting
Rancho Cucamonga, California, United States
Allergy & Asthma Medical Group and Research CenterRecruiting
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara ValleyRecruiting
San Jose, California, United States
San Jose Clinical TrialsRecruiting
San Jose, California, United States
North Bay Clinical ResearchRecruiting
Santa Rosa, California, United States
Providere ResearchRecruiting
West Covina, California, United States
Velocity Clinical Research - DenverRecruiting
Englewood, Colorado, United States
Clinical Research of West FloridaWithdrawn
Clearwater, Florida, United States
JY Research InstituteRecruiting
Cutler Bay, Florida, United States
Hillcrest Medical Research, LLCRecruiting
DeLand, Florida, United States
Clinical Site Partners LLC dba-LeesburgRecruiting
Leesburg, Florida, United States
Pharmax Research of South FloridaRecruiting
Miami, Florida, United States
Coral Research Clinic Corp.Recruiting
Miami, Florida, United States
Pro-Care Research Center, Corp.Recruiting
Miami Gardens, Florida, United States
Ogden Clinical Canyon ViewRecruiting
Tallahassee, Florida, United States
Care Access, TamaracRecruiting
Tamarac, Florida, United States
TBC ResearchRecruiting
Tamarac, Florida, United States
National Clinical TrialsRecruiting
Cordele, Georgia, United States
CPCC - Research, LLCRecruiting
East Point, Georgia, United States
Aeroallergy Research Laboratories of Savannah, Inc.Recruiting
Savannah, Georgia, United States
NexGen ResearchRecruiting
Boise, Idaho, United States
Treasure Valley Medical ResearchRecruiting
Boise, Idaho, United States
Velocity Clinical Research - BoiseWithdrawn
Meridian, Idaho, United States
Accellacare - DulyRecruiting
Winfield, Illinois, United States
Indiana Medical Research InstituteWithdrawn
Merrillville, Indiana, United States
Velocity Clinical Research - Sioux CityRecruiting
Sioux City, Iowa, United States
Velocity Clinical ResearchRecruiting
Lafayette, Louisiana, United States
Chesapeake Clinical Research, Inc.Recruiting
White Marsh, Maryland, United States
Mayflower ClinicalRecruiting
South Dartmouth, Massachusetts, United States
Deerborn ClinicRecruiting
Dearborn, Michigan, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Pulmonary Research Institute of SE MichiganRecruiting
Farmington Hills, Michigan, United States
Revive Research Institute, Inc.Recruiting
Southfield, Michigan, United States
Montana Medical Research, Inc.Recruiting
Missoula, Montana, United States
Henderson TrialsRecruiting
Henderson, Nevada, United States
A1 ClinicalRecruiting
Queens Village, New York, United States
Asheville Clinical ResearchRecruiting
Asheville, North Carolina, United States
Clinical Research of GastoniaWithdrawn
Gastonia, North Carolina, United States
North Carolina Clinical ResearchRecruiting
Raleigh, North Carolina, United States
Southeastern Research CenterRecruiting
Winston-Salem, North Carolina, United States
Midwest Clinical ResearchRecruiting
Dayton, Ohio, United States
Toledo Institute of Clinical Research Inc.Recruiting
Toledo, Ohio, United States
OK Clinical ResearchRecruiting
Edmond, Oklahoma, United States
Velocity Clinical ResearchRecruiting
Medford, Oregon, United States
Northwest Research CenterRecruiting
Portland, Oregon, United States
Clinical Research Associates of Central PARecruiting
DuBois, Pennsylvania, United States
Allergy & Asthma Diagnostic Treatment CenterRecruiting
Lancaster, Pennsylvania, United States
Temple University - ShenoyRecruiting
Philadelphia, Pennsylvania, United States
Care Access - MauldinRecruiting
Mauldin, South Carolina, United States
Allergy, Asthma & Sinus Center, LLCRecruiting
Myrtle Beach, South Carolina, United States
MBR - CharlestonRecruiting
North Charleston, South Carolina, United States
Clinical Research of Rock HillRecruiting
Rock Hill, South Carolina, United States
Premier Research Center, LLCRecruiting
Hendersonville, Tennessee, United States
New Phase Research & DevelopmentRecruiting
Knoxville, Tennessee, United States
TTS ResearchRecruiting
Boerne, Texas, United States
Proactive RGVRecruiting
Brownsville, Texas, United States
Ten20 Clinical Research, LLCRecruiting
Carrollton, Texas, United States
Javarra ResearchRecruiting
Conroe, Texas, United States
Dallas Allergy and Asthma CenterRecruiting
Dallas, Texas, United States
IntraCare Health CenterRecruiting
Dallas, Texas, United States
US Allergy & AsthmaRecruiting
Frisco, Texas, United States
IntraCare ClinicalRecruiting
Greenville, Texas, United States
Axsendo Clinical ResearchRecruiting
Houston, Texas, United States
Gulf Coast Clinical ResearchRecruiting
Houston, Texas, United States
Baylor Scott & White HealthWithdrawn
Temple, Texas, United States
Velocity Clinical Research - HamptonRecruiting
Hampton, Virginia, United States
A Study to Evaluate Solriktug in Adult Participants With Asthma · TrialPath