The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03041038
Phase
PHASE2
Status
Completed

Conditions

  • Autosomal Recessive Congenital Ichthyosis
  • Congenital Ichthyosiform Erythroderma
  • Epidermolytic Ichthyosis
  • Ichthyosis
  • Lamellar Ichthyosis
  • Netherton Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    Anti IL-17A antibody
  • Placebo — DRUG

Study Details

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.

Key Dates

Start date
Dec 31, 2016
Status verified
Aug 2021
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab
    Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
  • Placebo Comparator: Placebo
    Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial

Primary Outcome Measure

Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI) [ Time Frame: 16 Weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Department of Dermatology, Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Department of Dermatology Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in Chicago, IL

By research site
Department of Dermatology, Northwestern University Feinberg School of Medicine· Chicago, ILDepartment of Dermatology Icahn School of Medicine at Mount Sinai· New York, NY

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