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NCT03041038 · ClinicalTrials.gov registry record · Phase 2
The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
A Phase 2 study of Netherton Syndrome and Ichthyosis, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03041038: Completed Phase 2 study of Netherton Syndrome and Ichthyosis, sponsored by Northwestern University.
NCT03041038 is a Phase 2 study of Netherton Syndrome and Ichthyosis that has completed, run by Northwestern University. The registered enrollment target is 20 participants, below the 25-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (20% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03041038, a Phase 2 study of Netherton Syndrome and Ichthyosis, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Secukinumab
Study Locations (2)
Illinois
- Department of Dermatology, Northwestern University Feinberg School of Medicine - Chicago
New York
- Department of Dermatology Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-12 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 2 |
What the finished NCT03041038 record still lists
NCT03041038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 25-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (20% lower).
The record links to 6 conditions, with Netherton Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03041038 reports a single indexed study location in Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT03041038 about?
NCT03041038 is a clinical study titled "The Efficacy and Safety of Secukinumab in Patients With Ichthyoses". 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 ...
What is the current status of trial NCT03041038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2016-12. Estimated completion is 2020-08-31.
What conditions does trial NCT03041038 study?
This clinical trial studies the following conditions: Netherton Syndrome, Ichthyosis, Lamellar Ichthyosis, Autosomal Recessive Congenital Ichthyosis, Congenital Ichthyosiform Erythroderma.
What interventions are being tested in trial NCT03041038?
The interventions under investigation include: Placebo (DRUG), Secukinumab (DRUG).
Who is sponsoring clinical trial NCT03041038?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03041038 being conducted?
This trial has 2 study locations across Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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