NCT06496607

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Uniquity One (UNI) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	NSI-8226	Solrikitug
BIOLOGICAL	NSI-8226	Solrikitug
BIOLOGICAL	NSI-8226	Solrikitug
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2024-07-26
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2024-07-11
• Last updated: 2026-02-27

Locations

74 sites across 1 country: United States

Regulatory

• FDA-regulated drug study