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A Study to Evaluate Solriktug in Adult Participants With Asthma

Active Not RecruitingPhase 2

Sponsor: Uniquity One (UNI)

Conditions: Asthma

Interventions: NSI-8226, NSI-8226, NSI-8226, Placebo

Countries: United States

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (69)

Mobile, Alabama, United States
Peoria, Arizona, United States
Encinitas, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Rancho Cucamonga, California, United States
San Diego, California, United States
San Jose, California, United States
San Jose, California, United States
Santa Rosa, California, United States
West Covina, California, United States
Englewood, Colorado, United States
Cutler Bay, Florida, United States
DeLand, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Gardens, Florida, United States
Tallahassee, Florida, United States
Tamarac, Florida, United States
Tamarac, Florida, United States
Cordele, Georgia, United States
East Point, Georgia, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Boise, Idaho, United States
Winfield, Illinois, United States
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