CompletedPhase 2

The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

United States20 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 initiati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI)

Timeframe: 16 Weeks

Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16

Timeframe: 16 weeks of secukinumab/placebo double blind followed by 32 week open label treatment

Trial details

NCT IDNCT03041038

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-31

Results submitted2021-07-07

View on ClinicalTrials.gov More Ichthyosis trials