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

Phase 2

Recruiting

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

• Registration Number: 2024-510849-34-00
• Lead Sponsor: NI One Inc.

Brief Summary

Part A: To assess the efficacy of solrikitug, compared with placebo, on tissue inflammation and dysphagia symptoms in participants with EoE.

Part B: To assess the long-term safety and tolerability of solrikitug

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.

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: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-12
• Primary Completion: 2027-04-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

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
1_Part A: _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 6 eos/HPF at Week 24 _Change in DSQ total score from baseline to Week 24		1_Part A: _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 6 eos/HPF at Week 24 _Change in DSQ total score from baseline to Week 24
2_Part B: _Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability		2_Part B: _Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability

Secondary Outcome Measures

Name	Time	Method
1_ Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability		1_ Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability
2_PartA: _Peak eosinophil count per HPF in biopsy specimens as measured by the proportion of participants with <=15 eos/HPF at Week 24 _Percent change in peak eosinophil count from baseline to Week 24		2_PartA: _Peak eosinophil count per HPF in biopsy specimens as measured by the proportion of participants with <=15 eos/HPF at Week 24 _Percent change in peak eosinophil count from baseline to Week 24
3_Various Patient Reported Outcomes and Quality of Life Measures for EoE at different timepoint during Part A and Part B)		3_Various Patient Reported Outcomes and Quality of Life Measures for EoE at different timepoint during Part A and Part B)
4_PartA: __Summaries of concentration time data for each treatment/dose level _Summaries of ADA titers and ADA and NAb incidence		4_PartA: __Summaries of concentration time data for each treatment/dose level _Summaries of ADA titers and ADA and NAb incidence
6_PartB: _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 6 eos/HPF and the change in DSQ total score from Week 24 to Week 52 _Percent change in peak eosinophil count from Week 24 to Week 52 _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 15 eos/HPF from Week 24 to Week 52		6_PartB: _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 6 eos/HPF and the change in DSQ total score from Week 24 to Week 52 _Percent change in peak eosinophil count from Week 24 to Week 52 _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 15 eos/HPF from Week 24 to Week 52
7_PartB: __Listings and summary of concentration time data _Summaries of ADA titers and ADA and NAb incidence		7_PartB: __Listings and summary of concentration time data _Summaries of ADA titers and ADA and NAb incidence

Trial Locations

Locations (51)

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

Research Site 1037; 🇺🇸 Scottsdale, Arizona, United States

Research Site 1018; 🇺🇸 Peoria, Arizona, United States

Research Site 1003; 🇺🇸 Tucson, Arizona, United States

Research Site 1023; 🇺🇸 Englewood, California, United States

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

Research Site 1027; 🇺🇸 Cromwell, Connecticut, United States

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

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

Research Site 1007; 🇺🇸 Boise, Idaho, United States

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