A Study to Evaluate Solriktug in Adult Participants With Asthma

Phase 2

Recruiting

• Conditions: Asthma
• Interventions: Biological: NSI-8226; Biological: Placebo

• Registration Number: NCT06496607
• Lead Sponsor: Uniquity One (UNI)

Brief 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 124 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.

Study Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-11
• Study Start: 2024-07-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solrikitug low dose subcutaneous injection	NSI-8226	Solrikitug
Solrikitug mid dose subcutaneous injection	NSI-8226	Solrikitug
Solrikitug high dose subcutaneous injection	NSI-8226	Solrikitug
Placebo subcutaneous injection	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo	Over weeks 8 and 12	Change from baseline in blood eosinophil counts evaluated over Weeks 8 to 12

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple doses of solrikitug	To week 12	Adverse events (AEs) and serious adverse events (SAEs)

Trial Locations

Locations (28)

Research Site 006; 🇺🇸 Mobile, Alabama, United States

Research Site 021; 🇺🇸 Huntington Beach, California, United States

Research Site 031; 🇺🇸 Los Angeles, California, United States

Research Site 020; 🇺🇸 Newport Beach, California, United States

Research Site 024; 🇺🇸 Englewood, Colorado, United States

Research Site 001; 🇺🇸 Clearwater, Florida, United States

Research Site 026; 🇺🇸 Cutler Bay, Florida, United States

Research Site 025; 🇺🇸 Leesburg, Florida, United States

Research Site 003; 🇺🇸 Miami, Florida, United States

Research Site 022; 🇺🇸 Meridian, Idaho, United States

Research Site 018; 🇺🇸 Winfield, Illinois, United States

Research Site 019; 🇺🇸 Merrillville, Indiana, United States

Research Site 011; 🇺🇸 Sioux City, Iowa, United States

Research Site 005; 🇺🇸 Lafayette, Louisiana, United States

Research Site 016; 🇺🇸 Dartmouth, Massachusetts, United States

Research Site 033; 🇺🇸 Farmington Hills, Michigan, United States

Research Site 032; 🇺🇸 Missoula, Montana, United States

Research Site 014; 🇺🇸 Henderson, Nevada, United States

Research Site 004; 🇺🇸 Gastonia, North Carolina, United States

Research 013; 🇺🇸 Winston-Salem, North Carolina, United States

Research Site 007; 🇺🇸 Edmond, Oklahoma, United States

Research Site 009; 🇺🇸 Medford, Oregon, United States

Research Site 008; 🇺🇸 Rock Hill, South Carolina, United States

Research Site 028; 🇺🇸 Knoxville, Tennessee, United States

Research Site 017; 🇺🇸 Boerne, Texas, United States

Research Site 015; 🇺🇸 Houston, Texas, United States

Research Site 010; 🇺🇸 McKinney, Texas, United States

Research Site 023; 🇺🇸 Hampton, Virginia, United States