Phase 2
N=20
The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
Ichthyosis · Autosomal Recessive Congenital Ichthyosis · Lamellar Ichthyosis · Congenital Ichthyosiform Erythroderma · Epidermolytic Ichthyosis
Bottom Line
View on ClinicalTrials.gov: NCT03041038 ↗Enrolled (actual)
20
Serious AEs
5.3%
Results posted
Aug 2021
Primary outcome: Primary: Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI) — 2.4; 4.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Secukinumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI) |
2.4; 4.3 | — |
| PRIMARY Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16 |
5; 5; 10 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03041038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.