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Topical ATR12-351 for Netherton Syndrome

Phase 1
Recruiting
Research Sponsored by Azitra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome
Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effects of a drug, ATR12-351, for adult patients with Netherton Syndrome (NS). The drug will be applied to skin lesions on one side of the body, compared to a control on the other side.

Who is the study for?
Adults over 18 with Netherton Syndrome, affecting at least 20% of their body and confirmed SPINK5 gene mutation. Participants should not be using certain medications like biologics, antibiotics, or steroids, nor have had recent phototherapy or other clinical trials within the last month.
What is being tested?
The trial tests ATR12-351's safety and effects when applied to skin lesions in adults with Netherton Syndrome. One side of the body receives ATR12-351 while the other gets a control treatment for comparison, twice daily for two weeks.
What are the potential side effects?
While specific side effects are not listed here, they may include typical reactions to topical treatments such as redness, itching, irritation at the application site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Over 20% of my skin is affected by Netherton syndrome.
Select...
My condition involves a SPINK5 gene mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently in any clinical trials or have been in one within the last 30 days.
Select...
I am not currently using any immune system affecting drugs like steroids or biologics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Secondary study objectives
Investigator's Global Assessment (IGA)
NS-modified SCORAD
Patient's Global Assessment (PGA)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Internal controlled armExperimental Treatment1 Intervention
ATR12-351 on left side of body, vehicle on right side of body in one group; vehicle on left side of body, ATR12-351 on right side of body.

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Who is running the clinical trial?

Azitra Inc.Lead Sponsor
2 Previous Clinical Trials
81 Total Patients Enrolled
Mary Spellman, MDStudy DirectorAzitra Inc.
7 Previous Clinical Trials
964 Total Patients Enrolled
~6 spots leftby Aug 2025
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