BridgeMD
An early-stage clinical study of a potential new medicine for patients with Netherton Syndrome
EU CTIS ID: 2022-502853-32-00
What this study is testing
The primary objective of this study is to explore the safety and tolerability of DS-2325a in patients with NS.
- Phase I and Phase II (Integrated)- Other
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 18 to 65 years with clinical diagnosis of NS including at least 3 out of the 4 following clinical criteria: 1. Neonatal erythroderma; 2. Bamboo hair and/or alopecia; 3. Chronic atopy specified as food allergy and/or asthma and/or rhino-conjunctivitis and/or eczema for at least 2 years; 4. Ichthyosis linearis circumflexa or scaling erythroderma or equivalent. Eligible participants are those who have received treatment in the past that did not work and so need the further care.
- Immunohistochemistry documentation of absence of lympho-epithelial Kazal-type-related inhibitor (LEKTI) in the skin or confirmed serine peptidase inhibitor of Kazal type 5 (SPINK5) gene mutations.
- NS involvement of ≥20% of Body Surface Area (BSA) at both Screening and Baseline.
- Patients must give written informed consent to participation in the study prior to Screening.
- Patients must be willing to have skin tape harvests collected from lesional and non-lesional skin areas
You likely can't join if
- Any skin disease that may interfere with the diagnosis or evaluation of NS.
- Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before Screening visit.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
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.