RECRUITINGPhase 2INTERVENTIONAL
A Study to Evaluate Solriktug in Adult Participants With Asthma
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 Trial
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
NSI-8226
Solrikitug
BIOLOGICAL
NSI-8226
Solrikitug
BIOLOGICAL
NSI-8226
Solrikitug
BIOLOGICAL
Placebo
Placebo
Locations (20)
Velocity Clinical Research
Mobile, Alabama, United States
Phoenix Medical Group
Peoria, Arizona, United States
Warren W. Pleskow, M.D.
Encinitas, California, United States
Beach Physicians Clinical Research Corp.
Huntington Beach, California, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Orso Health
Long Beach, California, United States
Downtown LA Research Center
Los Angeles, California, United States
Newport Native MD, Inc.
Newport Beach, California, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, United States
San Jose Clinical Trials
San Jose, California, United States
North Bay Clinical Research
Santa Rosa, California, United States
Providere Research
West Covina, California, United States
Velocity Clinical Research - Denver
Englewood, Colorado, United States
Clinical Research of West Florida
Clearwater, Florida, United States
JY Research Institute
Cutler Bay, Florida, United States
Hillcrest Medical Research, LLC
DeLand, Florida, United States
Clinical Site Partners LLC dba-Leesburg
Leesburg, Florida, United States
Pharmax Research of South Florida
Miami, Florida, United States