QRX003 4% lotion for people with Netherton syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label expanded access protocol gives QRX003 4% lotion to participants with Netherton syndrome, applied topically to affected skin (excluding the scalp) twice daily for three months. Participants visit the clinic every 4–6 weeks for clinical exams, safety monitoring, and to review dosing diaries. Outcomes include changes in diseased skin area, clinician and patient itch/discomfort scores, safety events, and the proportion needing rescue therapy. Genetic confirmation of SPINK5 is required if not already available, and subjects must be on a stable topical regimen before enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is a male or non-pregnant female at least 14 years of age.
2. 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.
3. 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.
4. 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.
5. Subject is on a stable treatment regimen including topical therapy for NS prior to baseline that is expected to remain stable for the duration of the study

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. 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.
3. Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
4. Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
5. Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
6. Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
7. Subject has used ultraviolet phototherapy within the Treatment Area within 10 weeks prior to Visit 2/Baseline.
8. Subject has used topical prescription treatment in the Treatment Area within 10 weeks prior to Visit 2/Baseline.
9. Subject has used any topical steroid prescription treatments in the Treatment Area within 10 weeks prior to Visit 2/Baseline.
10. Subject is currently enrolled in an investigational drug, biologic, or device study.
11. Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: TI Clinical Research
• Email: clinicalresearch@therapeuticsinc.com
• Phone: 858-571-1800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 4% QRX003 lotion for Netherton syndrome skin

  This trial will test whether applying 4% QRX003 lotion twice daily for 12 weeks improves skin symptoms in people aged 4 and older with Netherton syndrome.

  Recruiting at 7 sites Phase 2/3 Quoin Pharmaceuticals · Fremont, California and 7 other locations · NCT07538583

• Skin and gut microbiome study in Netherton syndrome

  This study tests whether the skin, gut, and oral microbiomes differ in people with Netherton syndrome compared to those without the condition.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT07280091

• Evaluating QRX003 lotion for treating Netherton Syndrome

  This study is testing a new lotion called QRX003 to see if it can help people with Netherton Syndrome feel better when used with their regular treatments.

  Recruiting at 3 sites Phase 2/3 Quoin Pharmaceuticals · San Diego, California and 3 other locations · NCT05789056

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.