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

Phase 2

Recruiting

• Conditions: Eosinophilic Esophagitis (EoE)
• Interventions: Drug: Solrikitug High Dose; Other: Placebo; Drug: Solrikitug Low Dose; Drug: Solrikitug Mid Dose

• Registration Number: NCT06598462
• Lead Sponsor: Uniquity One (UNI)

Brief 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 157 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.

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2024-10-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2027-04-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solrikitug high dose	Solrikitug High Dose	Solrikitug
Placebo	Placebo	Placebo
Solrikitug low dose	Solrikitug Low Dose	Solrikitug
Solrikitug mid dose	Solrikitug Mid Dose	Solrikitug

Primary Outcome Measures

Name	Time	Method
Histological response of peak esophageal eosinophil per HPF count of ≤6	Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score	Week 24	The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs) and serious adverse events (SAEs)	To Week 24

Trial Locations

Locations (13)

Research Site 1108; 🇦🇺 New Castle, North South Wales, Australia

Research Site 1103; 🇦🇺 South Brisbane, Queensland, Australia

Research Site 1102; 🇦🇺 Fitzroy, Victoria, Australia

Research Site 1039; 🇺🇸 Dothan, Alabama, United States

Research Site 1015; 🇺🇸 San Diego, California, United States

Research Site 1040; 🇺🇸 Inverness, Florida, United States

Research Site 1001; 🇺🇸 Jacksonville, Florida, United States

Research Site 1004; 🇺🇸 Boston, Massachusetts, United States

Research Site 1006; 🇺🇸 Plymouth, Minnesota, United States

Research Site 1016; 🇺🇸 Reno, Nevada, United States

Research Site 1020; 🇺🇸 Harrisburg, Pennsylvania, United States

Research Site 1002; 🇺🇸 Ogden, Utah, United States

Research Site 1017; 🇺🇸 Sandy, Utah, United States