Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03041038
Other study ID # CAIN457AUS05T
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2016
Est. completion date August 31, 2020

Study information

Verified date August 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation. The vast majority are orphan disorders and are associated with extremely poor quality of life related to social ostracism from altered appearance, associated itchiness and discomfort, and functional limitations from the skin disease. Among the most common of these orphan disorders are autosomal recessive congenital ichthyosis (ARCI) with its phenotypic subsets of lamellar ichthyosis (ARCI-LI) and congenital ichthyosiform erythroderma (ARCI-CIE), epidermolytic ichthyosis (EI) and Netherton syndrome (NS). Therapy is time-consuming for patients or parents and is supportive, focusing on clearance of the scaling. There are no therapies based on growing understanding of what causes the disease. 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. Psoriasis, another inflammatory skin disorder with redness and scaling, has now been shown to result from IL-17 pathway activation and IL-17A inhibition is the most effective therapy known to treat psoriasis. Investigators propose that IL-17-targeting therapeutics will safely suppress the inflammation and possibly the other features of ichthyosis, improving quality of life. In this long-term, open-label extension, Investigators propose to treat adults with ichthyosis and at least moderate erythema with subcutaneously administered anti-IL-17 antibody (secukinumab) and to serially assess clinical response to this therapy and its safety.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Secukinumab
Anti IL-17A antibody
Placebo


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05979831 - A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome Phase 1/Phase 2
Completed NCT00208026 - Safety Study of Elidel (Pimecrolimus) 1% Cream to Treat Netherton Syndrome Phase 1/Phase 2
Completed NCT05583669 - A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects Phase 1
Completed NCT01428297 - A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome Phase 1
Recruiting NCT05856526 - A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome Phase 2/Phase 3
Recruiting NCT05789056 - Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome Phase 2/Phase 3
Recruiting NCT05521438 - Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome Phase 2/Phase 3
Completed NCT05388903 - A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects Phase 1
Recruiting NCT06137157 - Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome Phase 1
Not yet recruiting NCT05902663 - Natural History of Netherton Syndrome
Recruiting NCT04244006 - A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome Phase 2/Phase 3
Recruiting NCT03417856 - Defining the Skin and Blood Biomarkers of Ichthyosis
Completed NCT02113904 - Clinical Trial Using Humira in Netherton Syndrome Phase 2
Recruiting NCT05211830 - A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome Phase 1/Phase 2
Recruiting NCT01545323 - Gene Therapy for Netherton Syndrome Phase 1
Recruiting NCT02081313 - Natural History and Biological Study of Netherton Syndrome N/A