Clinical Trial: The Efficacy and Safety of Secukinumab in Patients With Ichthyoses
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief 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.
Detailed Summary: The ichthyoses are a group of lifelong genetic disorders which share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation. The vast majority are orphan disorders and are associated with extremely poor quality of life related to social ostracism from altered appearance, associated itchiness and discomfort, and functional limitations from the skin disease. Among the most common of these orphan disorders are autosomal recessive congenital ichthyosis (ARCI) with its phenotypic subsets of lamellar ichthyosis (ARCI-LI) and congenital ichthyosiform erythroderma (ARCI-CIE), epidermolytic ichthyosis (EI) and Netherton syndrome (NS). Therapy is time-consuming for patients or parents and is supportive, focusing on clearance of the scaling. There are no therapies based on growing understanding of what causes the disease. 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. Psoriasis, another inflammatory skin disorder with redness and scaling, has now been shown to result from IL-17 pathway activation and IL-17A inhibition is the most effective therapy known to treat psoriasis. Investigators propose that IL-17-targeting therapeutics will safely suppress the inflammation and possibly the other features of ichthyosis, improving quality of life. In this long-term, open-label extension, Investigators propose to treat adults with ichthyosis and at least moderate erythema with subcutaneously administered anti-IL-17 antibody (secukinumab) and to serially assess clinical response to this therapy and its safety.
Sponsor: Northwestern University
Current Primary Outcome:
- Reduction at week 16 in the Ichthyosis Area Severity Index (IASI) [ Time Frame: 16 Weeks ]Primary Efficacy Endpoint
- Occurrence of bacterial or fungal mucocutaneous infection through week 16 [ Time Frame: 16 weeks ]Primary Safety Endpoint
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in the IASI-E and IASI-S at week 16 [ Time Frame: 16 weeks ]
- Change in CISI (Congenital Ichthyosis Severity Index) for skin redness/ erythema as well as skin hyperkeratosis/scaling 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 50% reduction in IASI at week 16 [ Time Frame: Week 16 ]
- A 75% reduction in composite and individual IASIs at week 16 [ Time Frame: Week 16 ]
- Reduction in Bodemer score at week 16 [ Time Frame: Week 16 ]
- A 3-point reduction in patient-reported itch and pain at week 16 [ Time Frame: Week 16 ]
- Improvement in the 5-D itch score [ Time Frame: Week 16 ]
Original Secondary Outcome: Same as current
Information By: Northwestern University
Dates:
Date Received: January 17, 2017
Date Started: December 2016
Date Completion: October 2019
Last Updated: January 31, 2017
Last Verified: January 2017
