NCT06598462

A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study With an Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (ALAMERE)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• 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 solrikitug in adult participants with eosinophilic esophagitis.

Detailed description

This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension 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 EoE. Approximately 180 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period. The study also includes a post-treatment follow-up period of 16 weeks.

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
BIOLOGICAL	Solrikitug Low Dose	Solrikitug low dose subcutaneous injection
BIOLOGICAL	Solrikitug Mid Dose	Solrikitug mid dose subcutaneous injection
BIOLOGICAL	Solrikitug High Dose	Solrikitug high dose subcutaneous injection
OTHER	Placebo	Placebo subcutaneous injection

Timeline

• Start date: 2024-10-16
• Primary completion: 2027-04-30
• Completion: 2027-08-31
• First posted: 2024-09-19
• Last updated: 2026-03-20

Locations

73 sites across 9 countries: United States, Australia, Belgium, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study