BridgeMD
A study to test whether spesolimab helps people with skin disease called Netherton syndrome
EU CTIS ID: 2022-501104-10-00
What this study is testing
Evaluate the treatment response of spesolimab
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients, aged 12 years and older (weight minimum is 35kg).
- Confirmed diagnosis of NS (SPINK5 causative mutations) at baseline
- At least moderate severity of erythema at baseline (IASI score ≥ 16 and IASI-E score ≥8) and ≥ 3 on IGA score
- Signed and dated written informed consent and assent in accordance with ICH-GCP and local legislation prior to admission in the trial
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the Clinical Trial Protocol (CTP) as well as in the patient information.
You likely can't join if
- Patients who have used topical corticosteroids (medium to high, US class I-V), topical retinoids, topical calcineurin inhibitors or keratolytics within 1 week prior to randomisation
- Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis at the time of randomisation. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- Further criteria apply
- Patients who have used emollient on the area to be biopsied in the previous 24 hours
- Patients who have used systemic retinoids, other systemic immunosuppressants, systemic corticosteroids or phototherapy within 4 weeks prior to randomisation
- Patients who have used systemic antibiotics within 2 weeks prior to randomisation
See the full eligibility criteria
- Male or female patients, aged 12 years and older (weight minimum is 35kg).
- Confirmed diagnosis of NS (SPINK5 causative mutations) at baseline
- At least moderate severity of erythema at baseline (IASI score ≥ 16 and IASI-E score ≥8) and ≥ 3 on IGA score
- Signed and dated written informed consent and assent in accordance with ICH-GCP and local legislation prior to admission in the trial
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the Clinical Trial Protocol (CTP) as well as in the patient information.
- Patients who have used topical corticosteroids (medium to high, US class I-V), topical retinoids, topical calcineurin inhibitors or keratolytics within 1 week prior to randomisation
- Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis at the time of randomisation. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- Further criteria apply
- Patients who have used emollient on the area to be biopsied in the previous 24 hours
- Patients who have used systemic retinoids, other systemic immunosuppressants, systemic corticosteroids or phototherapy within 4 weeks prior to randomisation
- Patients who have used systemic antibiotics within 2 weeks prior to randomisation
- Patients who have received live vaccines within 4 weeks prior to randomisation
- Patients who have received investigational products, biologics or immunoglobulins within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
- Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
- Patients who have any prior exposure to BI 655130 or another IL-36R inhibitor biologics.
- Increased risk of infectious complications (e.g., recent pyogenic infection, any congenital or acquired immunodeficiency (e.g., HIV), past organ or stem cell transplantation), as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Australia
- United Kingdom
- China
- Israel
- Japan
- United States
- Malaysia
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Australia; United Kingdom; China; Israel; Japan and 2 more location(s). 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 EU CTIS; the study team decides eligibility.