Netherton Syndrome Clinical Trial
Official title:
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Maintenance Dosing Period to Evaluate the Efficacy and Safety of Secukinumab in Patients With Ichthyoses
Verified date | August 2021 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation. There are no therapies based on growing understanding of what causes the disease. However, there have been recent discoveries of marked elevations in expression of interleukin-17A (IL-17A) and IL-17-related cytokines in the skin of individuals with ichthyosis, which may explain the inflammation. Investigators propose that IL-17-targeting therapeutics will safely suppress the inflammation and possibly the other features of ichthyosis, improving quality of life.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject has provided informed consent - Subjects are at least 18 years of age or older at the time of screening - Female subjects must not be pregnant or breast-feeding - Female subjects of child-bearing potential with a negative urine pregnancy test and using at least one form of contraception (abstinence allowed) - Subjects must have a confirmed diagnosis of ARCI (divided phenotypically into ARCI-LI or ARCI-CIE), EI or NS (by genotype or willingness to be genotyped) - Subjects must be clinically judged to be immunocompetent. - Subjects will have no allergy to secukinumab or components of the product. - Subjects will have normal baseline laboratory testing (CMP, CBC, HIV negative, hepatitis B, C negative, QuantiFERON®-TB gold negative) - Subjects must have an erythema score of at least 18 on IASI and an IASI-E score of 12 (at least moderate severity of erythema) at baseline Exclusion Criteria: - Subjects who are unable to give informed consent or assent. - Subjects without a confirmed diagnosis ARCI, EI, or NS. - Subjects who have a known allergy to secukinumab. - Female subjects who are pregnant, considering becoming pregnant, or will breastfeed. - Subjects who have prior biologic use targeting IL-17A/IL-17 receptor A or IL-12/IL-23 or who have prior use of TNF-alpha blockers. - Subjects who have used a systemic retinoid within one month prior to initiation. - Subjects who have used topical retinoids or keratolytics within one week prior to initiation. - Subjects who have used emollient on the area to be biopsied in the previous 24 hours |
Country | Name | City | State |
---|---|---|---|
United States | Department of Dermatology, Northwestern University Feinberg School of Medicine | Chicago | Illinois |
United States | Department of Dermatology Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI) | Primary Efficacy Endpoint. The IASI score was modelled after the Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI), commonly used in clinical trials for atopic dermatitis and psoriasis, respectively. This scale measures erythema and scaling and has a range of 0-48 (sum of a max score of 24 for erythema and 24 for scaling). A higher score means worse clinical severity. Mean difference IASI total score at Baseline was compared to IASI total score at Week 16. | 16 Weeks | |
Primary | Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16 | Primary Safety Endpoint | 16 weeks of secukinumab/placebo double blind followed by 32 week open label treatment |
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