Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Netherton Syndrome

In brief

This study has been designed to determine the safety, tolerability and efficacy of QRX003 lotion 2%, 4% QAM or 4% BID in subjects with Netherton Syndrome (NS) in comparison to vehicle

Key facts

Study ID

NCT05521438

Run by

Quoin Pharmaceuticals

People needed

30

Starts

2022-06-23

Expected to finish

2026-12-31

Last updated by the study team

2026-03-16

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is a male or non-pregnant female at least 14 years of age.
• Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
• Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation.
• Subject has NS lesions in the Treatment Area (i.e., arms or lower legs).
• Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation.

You may not qualify if…

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
• Subject has Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females
• Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
• Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
• Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
• Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
• Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline.
• Subject has used systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline.
• Subject has used systemic biologic therapy for NS.
• Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
• Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline.
• Subject is currently enrolled in an investigational drug, biologic, or device study.
• Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Where it is running

• Site #1 — San Diego, California, United States
• Site #4 — Indianapolis, Indiana, United States
• Site #5 — Quincy, Massachusetts, United States
• Site #3 — Charleston, South Carolina, United States
• Site #2 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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