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The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041038
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date November 23, 2020
Study Start Date  ICMJE December 2016
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Reduction at week 16 in the Ichthyosis Area Severity Index (IASI) [ Time Frame: 16 Weeks ]
    Primary Efficacy Endpoint
  • Occurrence of bacterial or fungal mucocutaneous infection through week 16 [ Time Frame: 16 weeks ]
    Primary Safety Endpoint
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Change in the IASI-E and IASI-S at week 16 [ Time Frame: 16 weeks ]
  • Change in CISI (Congenital Ichthyosis Severity Index) for skin redness/ erythema as well as skin hyperkeratosis/scaling at week 16 [ Time Frame: Week 16 ]
  • A 2-point reduction in CISI for redness/erythema as well as skin hyperkeratosis/scaling at week 16 [ Time Frame: Week 16 ]
  • A 50% reduction in IASI at week 16 [ Time Frame: Week 16 ]
  • A 75% reduction in composite and individual IASIs at week 16 [ Time Frame: Week 16 ]
  • Reduction in Bodemer score at week 16 [ Time Frame: Week 16 ]
  • A 3-point reduction in patient-reported itch and pain at week 16 [ Time Frame: Week 16 ]
  • Improvement in the 5-D itch score [ Time Frame: Week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2017)
  • Reduction in transepidermal water loss (TEWL), a functional measure of barrier, at week 16 [ Time Frame: Week 16 ]
  • Reduction in the Dermatology Life Quality Index (DLQI) at week 16 [ Time Frame: Week 16 ]
  • Reduction in the iQoL-32 index at week 16 [ Time Frame: Week 16 ]
  • Occurrence of any AEs by week 16 [ Time Frame: Week 16 ]
  • Occurrence of infections by week 16 [ Time Frame: Week 16 ]
  • Occurrence of SAEs by week 16 [ Time Frame: Week 16 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
Official Title  ICMJE 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
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ichthyosis
  • Autosomal Recessive Congenital Ichthyosis
  • Lamellar Ichthyosis
  • Congenital Ichthyosiform Erythroderma
  • Epidermolytic Ichthyosis
  • Netherton Syndrome
Intervention  ICMJE
  • Drug: Secukinumab
    Anti IL-17A antibody
    Other Name: Cosentyx
  • Drug: Placebo
    Other Name: Sterile Saline
Study Arms  ICMJE
  • Experimental: Secukinumab
    Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
    Intervention: Drug: Secukinumab
  • Placebo Comparator: Placebo
    Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
36
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041038
Other Study ID Numbers  ICMJE CAIN457AUS05T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy Paller, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Amy Paller, MD Northwestern University Department of Dermatology
Principal Investigator: Emma Guttman-Yassky, MD, PhD Mt. Sinai Hospital Department of Dermatology
PRS Account Northwestern University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP