A Study to Evaluate Solriktug in Adult Participants With Asthma
Phase 2 – studying effectiveness and dosage
Conditions:
Asthma
Sponsor: Uniquity One (UNI)
trial.available_in:
БГ
Overview
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
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.
Who can participate
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.
Interventions
NSI-8226
BIOLOGICAL
NSI-8226
BIOLOGICAL
NSI-8226
BIOLOGICAL
Placebo
BIOLOGICAL
Locations
69
United States (69)
Asheville Clinical Research
Asheville , North Carolina
TTS Research
Boerne , Texas
NexGen Research
Boise , Idaho
Treasure Valley Medical Research
Boise , Idaho
Proactive RGV
Brownsville , Texas
Ten20 Clinical Research, LLC
Carrollton , Texas
Javarra Research
Conroe , Texas
National Clinical Trials
Cordele , Georgia
JY Research Institute
Cutler Bay , Florida
Dallas Allergy and Asthma Center
Dallas , Texas
IntraCare Health Center
Dallas , Texas
Midwest Clinical Research
Dayton , Ohio
Deerborn Clinic
Dearborn , Michigan
Hillcrest Medical Research, LLC
DeLand , Florida
Henry Ford Health System
Detroit , Michigan
Clinical Research Associates of Central PA
DuBois , Pennsylvania
CPCC - Research, LLC
East Point , Georgia
OK Clinical Research
Edmond , Oklahoma
Warren W. Pleskow, M.D.
Encinitas , California
Velocity Clinical Research - Denver
Englewood , Colorado
Pulmonary Research Institute of SE Michigan
Farmington Hills , Michigan
US Allergy & Asthma
Frisco , Texas
IntraCare Clinical
Greenville , Texas
Velocity Clinical Research - Hampton
Hampton , Virginia
Henderson Trials
Henderson , Nevada
Premier Research Center, LLC
Hendersonville , Tennessee
Axsendo Clinical Research
Houston , Texas
Gulf Coast Clinical Research
Houston , Texas
Beach Physicians Clinical Research Corp.
Huntington Beach , California
New Phase Research & Development
Knoxville , Tennessee
Biosolutions Clinical Research Center
La Mesa , California
Velocity Clinical Research
Lafayette , Louisiana
Allergy & Asthma Diagnostic Treatment Center
Lancaster , Pennsylvania
Clinical Site Partners LLC dba-Leesburg
Leesburg , Florida
Orso Health
Long Beach , California
Downtown LA Research Center
Los Angeles , California
Care Access - Mauldin
Mauldin , South Carolina
Velocity Clinical Research
Medford , Oregon
Pharmax Research of South Florida
Miami , Florida
Coral Research Clinic Corp.
Miami , Florida
Pro-Care Research Center, Corp.
Miami Gardens , Florida
Montana Medical Research, Inc.
Missoula , Montana
Velocity Clinical Research
Mobile , Alabama
Allergy, Asthma & Sinus Center, LLC
Myrtle Beach , South Carolina
Newport Native MD, Inc.
Newport Beach , California
MBR - Charleston
North Charleston , South Carolina
Phoenix Medical Group
Peoria , Arizona
Temple University - Shenoy
Philadelphia , Pennsylvania
Northwest Research Center
Portland , Oregon
A1 Clinical
Queens Village , New York
North Carolina Clinical Research
Raleigh , North Carolina
Prospective Research Innovations Inc.
Rancho Cucamonga , California
Clinical Research of Rock Hill
Rock Hill , South Carolina
Allergy & Asthma Medical Group and Research Center
San Diego , California
Allergy & Asthma Associates of Santa Clara Valley
San Jose , California
San Jose Clinical Trials
San Jose , California
North Bay Clinical Research
Santa Rosa , California
Aeroallergy Research Laboratories of Savannah, Inc.
БГ