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)
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.