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New treatment option for Netherton Syndrome
Official title Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome
ClinicalTrials.gov ID: NCT06137157
What this study is testing
What is ATR12-351?
ATR12-351 is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for netherton syndrome.
Also referred to as ATR-12.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Use of biologic therapies, antibiotics, antihistamines, corticosteroids, retinoids, disease-modifying antirheumatic drugs (DMARDs), immunosuppressive...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.