Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome
ConditionNetherton Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzitra Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ATR12-351
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov