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New treatment option for Netherton Syndrome
Official title Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
ClinicalTrials.gov ID: NCT07538583
What this study is testing
What is QRX003?
QRX003 is an investigational medicine, given as an once-daily, 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
- This is a multicenter, open-label study to evaluate the safety, tolerability, and efficacy of 4% QRX003 lotion applied twice daily (BID) for 12 weeks to Netherton syndrome (NS) diseased skin in all affected areas of the body excluding the scalp (the Treatment Area), totaling approximately 50% Body Surface Area (BSA) or more.
- 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 4 and older
You may be able to join if
- Participant is male or female and at least 4 years of age.
- Participant has provided written informed consent/assent. Based on the participant's age and local regulations , a participant under legal age of...
- Female participants must either not have experienced menarche, be postmenopausal , or be surgically sterile , or use a highly effective method of...
- Participant has a genetically confirmed diagnosis of NS prior to Visit 2/Baseline. Participants without existing results must undergo genetic testing...
You likely can't join if
- Participant is pregnant, lactating, or is planning to become pregnant during the study.
- Participant has active cancer of any type excluding melanoma skin cancer outside of the Treatment Area.
- Participant has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled, in the opinion of the...
- Participant has evidence of active infection during Screening, or serious infection within 30 days prior to Visit 2/Baseline.
- Participant has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
- Participant has ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the opinion...
See the full eligibility criteria
- Participant is male or female and at least 4 years of age.
- Participant has provided written informed consent/assent. Based on the participant's age and local regulations , a participant under legal age of consent must provide written informed assent and be accompanied by the...
- Female participants must either not have experienced menarche, be postmenopausal , or be surgically sterile , or use a highly effective method of birth control , for the duration of the study and for 3 months following...
- Participant has a genetically confirmed diagnosis of NS prior to Visit 2/Baseline. Participants without existing results must undergo genetic testing at Visit 1/Screening, which must confirm the diagnosis of NS in order...
- Participant is pregnant, lactating, or is planning to become pregnant during the study.
- Participant has active cancer of any type excluding melanoma skin cancer outside of the Treatment Area.
- Participant has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled, in the opinion of the investigator.
- Participant has evidence of active infection during Screening, or serious infection within 30 days prior to Visit 2/Baseline.
- Participant has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
- Participant has ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the opinion of the investigator, should exclude participation in the study.
- Participant has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline.
- Participant has used systemic non-biologics prescription treatment for NS or that in the opinion of the investigator may affect the participant's NS (examples include, but are not limited to antibiotics, retinoids...
- Participant has used systemic biologic therapy for NS or that in the opinion of the investigator may affect the participant's NS within 5 half-lives of the biologic therapy prior to Visit 2/Baseline. Published or...
- Participant has used topical prescription treatments, including steroids (examples include, but are not limited to keratolytics, steroids, retinoids, etc.) in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
- Participant has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline.
- Participant is currently enrolled in an investigational drug, biologic, or device study.
The study team makes the final eligibility decision.
Where it's taking place
- Fremont, California, United States
- New Haven, Connecticut, 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, 4 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fremont, California, United States; New Haven, Connecticut, 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.