RECRUITING

Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome

Conditions

Netherton Syndrome Ichthyosis Skin disease ichthyosis linearis circumflexa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-Blind, Vehicle-Controlled, First-in-Human Safety, Tolerability and Proof-of-Concept Study of Topical ATR12-351 in Adults With Netherton Syndrome

Quick Facts

Study Start:2024-06-19

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06137157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Travis Whitfill

CONTACT

203-646-6446

clinicaltrials@azitrainc.com

Principal Investigator

Mary Spellman, MD

STUDY_DIRECTOR

Azitra Inc.

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Azitra Inc.

Mary Spellman, MD, STUDY_DIRECTOR, Azitra Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-19

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2024-06-19

Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

Ichthyosis
Netherton syndrome
Skin disease
ichthyosis linearis circumflexa

Additional Relevant MeSH Terms

Netherton Syndrome