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

Sponsor
GWT-TUD GmbH
Study ID
NCT03568136
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab 300 mg — DRUG
    Solution for injection in pre-filled syringe
  • Placebo — DRUG
    Solution for injection in pre-filled syringe

Study Details

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.

Key Dates

Start date
Sep 18, 2018
Status verified
May 2020
Primary completion
May 4, 2020
Completion
May 4, 2020

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    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 were followed up visits at week 20 and 24. Placebo will be administered as 2 subcutaneous injections.
  • Placebo Comparator: Treatment Arm B
    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 were followed up visits at week 20 and 24.

Primary Outcome Measure

Reduction in EASI [ Time Frame: week 4 (visit 4) ]

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