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

NCT06598462 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-03-20

No results posted yet for this study

Summary

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.

Conditions

  • Eosinophilic Esophagitis (EoE)

Interventions

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

Sponsors & Collaborators

  • Uniquity One (UNI)

    lead INDUSTRY

Principal Investigators

  • Andrew W Lee, MD · Vice President, Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2027-04-30
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598462 on ClinicalTrials.gov