NCT03568136

Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

A Randomized, Placebo-controlled, Double-blind Study to Scrutinize the Efficacy of Secukinumab in Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: GWT-TUD GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis. The effectiveness of Secukinumab is determined on the reduction of the eczema score EASI 50 (Eczema Area and Severity Index, a tool to measure the severity of atopic dermatitis) at week 4.

Detailed description

Secukinumab is a humanized anti-IL-17A monoclonal antibody. Since Secukinumab is well established in the therapy of psoriasis with a highly favorable benefit to risk ration and IL-17 has been described in atopic dermatitis this study aims to investigate the effects of anti-IL-17 in atopic dermatitis. This is a randomized, placebo-controlled, multicenter, double-blinded study to evaluate the efficacy and safety of subcutaneous Secukinumab compared to placebo in 45 adults with atopic dermatitis. The study consists of 3 periods: a screening period of at least -14 days and up to -35 days, and a treatment period of 16 weeks and a follow-up period of additional 8 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 2:1 to treatment arm A or B at Day -7 (+2 to -15) during the randomization visit. Secukinumab (Cosentyx®) will be used according to the official label and SmPC (Summary of Product Characteristics). Patients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints visits are performed at weeks 20 and 24. Placebo will be administered as 2 subcutaneous injections. Patients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints visits are performed at weeks 20 and 24.

Conditions

• Dermatitis, Atopic
• Eczema, Atopic
• Neurodermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Secukinumab 300 mg	Solution for injection in pre-filled syringe
DRUG	Placebo	Solution for injection in pre-filled syringe

Timeline

• Start date: 2018-09-18
• Primary completion: 2020-05-04
• Completion: 2020-05-04
• First posted: 2018-06-26
• Last updated: 2021-05-03

Locations

5 sites across 1 country: Germany