The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

NCT03041038 | Completed Phase 2 Results DMC

• 1 other identifier: CAIN457AUS05T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Secukinumab

EXPERIMENTAL

Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial

Drug: Placebo

Interventions

Secukinumab DRUG

Anti IL-17A antibody

Also known as: Cosentyx

Secukinumab

Placebo DRUG

Also known as: Sterile Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Department of Dermatology, Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Department of Dermatology Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Lefferdink R, Rangel SM, Chima M, Ibler E, Pavel AB, Kim H, Wu B, Abu-Zayed H, Wu J, Jackson K, Singer G, Choate KA, Guttman-Yassky E, Paller AS. Secukinumab responses vary across the spectrum of congenital ichthyosis in adults. Arch Dermatol Res. 2023 Mar;315(2):305-315. doi: 10.1007/s00403-022-02325-3. Epub 2022 Feb 26.

  PMID: 35218370 DERIVED

MeSH Terms

Conditions

Ichthyosis; Ichthyosis, Lamellar; Ichthyosiform Erythroderma, Congenital; Hyperkeratosis, Epidermolytic; Netherton Syndrome

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Abnormalities, Multiple

Results Point of Contact

• Title: Dr. Amy Paller
• Organization: Northwestern University

NUderm-research@northwestern.edu

3126953721

Study Officials

• Amy Paller, MD

  Northwestern University Department of Dermatology

  PRINCIPAL INVESTIGATOR

• Emma Guttman-Yassky, MD, PhD

  Mt. Sinai Hospital Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 2, 2017
• Study Start: December 1, 2016
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: August 25, 2021
• Results First Posted: August 25, 2021

Record last verified: 2021-08

Locations

US (2)