The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
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|ClinicalTrials.gov Identifier: NCT03041038|
Recruitment Status : Completed
First Posted : February 2, 2017
Results First Posted : August 25, 2021
Last Update Posted : August 25, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Ichthyosis Autosomal Recessive Congenital Ichthyosis Lamellar Ichthyosis Congenital Ichthyosiform Erythroderma Epidermolytic Ichthyosis Netherton Syndrome||Drug: Secukinumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||August 31, 2020|
|Actual Study Completion Date :||August 31, 2020|
Secukinumab 300mg (liquid formation) administered subcutaneously weekly for 5 weeks then monthly until end of trial
Anti IL-17A antibody
Other Name: Cosentyx
Placebo Comparator: Placebo
Placebo (sterile saline) 2ml administered subcutaneously weekly for 5 weeks then monthly until end of trial
Other Name: Sterile Saline
- Reduction at Week 16 in the Ichthyosis Area Severity Index (IASI) [ Time Frame: 16 Weeks ]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.
- Total Number of Bacterial or Fungal Mucocutaneous Infections Through Week 16 [ Time Frame: 16 weeks of secukinumab/placebo double blind followed by 32 week open label treatment ]Primary Safety Endpoint
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041038
|United States, Illinois|
|Department of Dermatology, Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Department of Dermatology Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Amy Paller, MD||Northwestern University Department of Dermatology|
|Principal Investigator:||Emma Guttman-Yassky, MD, PhD||Mt. Sinai Hospital Department of Dermatology|
Documents provided by Amy Paller, Northwestern University:
|Responsible Party:||Amy Paller, Principal Investigator, Northwestern University|
|Other Study ID Numbers:||
|First Posted:||February 2, 2017 Key Record Dates|
|Results First Posted:||August 25, 2021|
|Last Update Posted:||August 25, 2021|
|Last Verified:||August 2021|
Ichthyosiform Erythroderma, Congenital
Infant, Newborn, Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous