Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06137157

Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome

Led by Azitra Inc. · Updated on 2026-02-05

12

Participants Needed

2

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objectives of this clinical trial are to evaluate the safety and tolerability of topically applied ATR12-351, to understand what the body does to ATR12-351, and to observe treatment benefits of the drug in approximately 12 adult patients with Netherton Syndrome (NS). ATR12-351 will be applied to skin lesions on one side of the body, while the vehicle control will be applied to similar lesion on the other side of the body twice daily for 2 weeks.

CONDITIONS

Official Title

Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Confirmed mutation of the SPINK5 gene
  • Skin changes consistent with Netherton syndrome affecting 20% or more of body surface area
Not Eligible

You will not qualify if you...

  • Use of biologic therapies, antibiotics, antihistamines, corticosteroids, retinoids, DMARDs, immunosuppressive agents, PDE4 inhibitors, topical calcineurin inhibitors, or topical JAK inhibitors
  • Presence of open wounds or extensive excoriation preventing proper ointment application
  • Participation in another clinical study or expanded access program with investigational drug/device within 30 days before screening
  • Living with an immunocompromised person from baseline through 2 weeks after treatment
  • History of ultraviolet phototherapy in the planned treatment area within 4 weeks before baseline

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

2

Yale University

New Haven, Connecticut, United States, 06519

Completed

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Research Team

T

Travis Whitfill

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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