The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03041038
• Date of registration: 17/01/2017
• Prospective Registration: No
• Primary sponsor: Northwestern University
• Public title: The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
• Scientific 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
• Date of first enrolment: December 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03041038
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Emma Guttman-Yassky, MD, PhD
• Affiliation: Mt. Sinai Hospital Department of Dermatology

• Name: Amy Paller, MD
• Affiliation: Northwestern University Department of Dermatology

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ichthyosis

Autosomal Recessive Congenital Ichthyosis

Congenital Ichthyosiform Erythroderma

Netherton Syndrome

Epidermolytic Ichthyosis

Lamellar Ichthyosis

Intervention(s)

Drug: Secukinumab

Drug: Placebo

Primary Outcome(s)

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

Occurrence of bacterial or fungal mucocutaneous infection through week 16 [Time Frame: 16 weeks]

Secondary Outcome(s)

A 75% reduction in composite and individual IASIs at week 16 [Time Frame: Week 16]

Change in the IASI-E and IASI-S at week 16 [Time Frame: 16 weeks]

Improvement in the 5-D itch score [Time Frame: Week 16]

Change in CISI (Congenital Ichthyosis Severity Index) for skin redness/ erythema as well as skin hyperkeratosis/scaling at week 16 [Time Frame: Week 16]

Reduction in Bodemer score at week 16 [Time Frame: Week 16]

A 50% reduction in IASI 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 3-point reduction in patient-reported itch and pain at week 16 [Time Frame: Week 16]

Secondary ID(s)

CAIN457AUS05T

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Icahn School of Medicine at Mount Sinai