NCT06469385

Topical ENS-002 for Atopic Dermatitis in Adults

Phase 1 First in Human Dose Escalation and Safety Study of Topical ENS-002 for Atopic Dermatitis in Adults

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Concerto Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine the safety and effects of ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria in participants with atopic dermatitis.

Detailed description

This is a Phase 1, open-label, non-randomized, study investigating ENS-002, a live biotherapeutic product (LBP) consisting of commensal, clonal non-pathogenic bacteria The purpose of this dose escalation study is to determine the recommended Phase 2 dose (RP2D) of ENS-002 in participants with mild, moderate or severe atopic dermatitis. Participation in this study will continue until dose limiting toxicity or therapy intolerance, or participant withdrawal.

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
BIOLOGICAL	ENS-002	Live biotherapeutic product (LBP) consisting of commensal, clonal, non-pathogenic bacteria. Low Dose ENS-002 High Dose ENS-002

Timeline

• Start date: 2024-09-18
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2024-06-21
• Last updated: 2025-08-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study