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Tests treatment safety and results for Netherton Syndrome
Official title Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome
ClinicalTrials.gov ID: NCT05789056
What this study is testing
What is QRX003, 4% Lotion?
QRX003, 4% Lotion is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for netherton syndrome.
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
- To assess the safety, tolerability, and efficacy of QRX003 lotion (4%) when added to standard of care treatment regimen, including systemic therapy in subjects with Netherton syndrome
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join 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...
- 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...
- 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...
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- Subject is on a stable treatment regimen including systemic therapy for NS prior to baseline that is expected to remain stable for the duration of the study
- 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 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Indianapolis, Indiana, United States
- Quincy, Massachusetts, United States
- San Antonio, Texas, 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, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Indianapolis, Indiana, United States; Quincy, Massachusetts, United States; San Antonio, Texas, 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.