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Active Not Recruiting NCT06496607

A Study to Evaluate Solriktug in Adult Participants With Asthma

Conditions: Asthma

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 145
Sponsor: Uniquity One (UNI)

Location: Velocity Clinical Research Mobile Alabama

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06496607). StuddyBuddy aggregates publicly available trial information.