Status:
RECRUITING
Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome
Lead Sponsor:
Azitra Inc.
Conditions:
Netherton Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
Netherton syndrome (NS) is a rare but severe autosomal recessive disease that affects the skin, hair, and immune system. NS presents at birth with red skin covered by fine scales, a specific hair shaf...
Eligibility Criteria
Inclusion
- Adults ≥18 years of age
- Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene
- Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome
Exclusion
- Use of biologic therapies, antibiotics, antihistamines, corticosteroids, retinoids, disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, phosphodiesterase-4 (PDE4) inhibitors, topical calcineurin inhibitors, or topical Janus kinase (JAK) inhibitors
- Open wounds or extensive areas of excoriation precluding identification of appropriate application sites in the Investigator's judgment
- Concurrent involvement in any other clinical study/expanded access program with an investigational drug or device or has participated in a clinical study within 30 days prior to the screening visit
- Residing with an immunocompromised person in the same dwelling from the baseline visit through 2 weeks after the treatment period
- History of ultraviolet phototherapy within the planned treatment area 4 weeks prior to baseline
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06137157
Start Date
June 19 2024
End Date
August 1 2026
Last Update
December 23 2025
Active Locations (2)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Yale University
New Haven, Connecticut, United States, 06519