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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Solution for injection in pre-filled syringe
Solution for injection in pre-filled syringe
Klinische Forschung Dresden GmbH
Dresden, Germany
Carl Gustav Carus University Hospital, Department of Dermatology
Dresden, Germany
SRH Wald-Klinikum Gera, Center for Clinical Studies
Gera, Germany
Hannover Medical School, Department for Dermatology, Allergy and Venereology
Hanover, Germany
Reduction in EASI
Proportion of patients with a reduction of the eczema score EASI of at least 50%. The proportions are then compared between study arms.
Time frame: week 4 (visit 4)
Reduction of EASI
To compare the proportions of patients with a reduction of the eczema score EASI 50.
Time frame: baseline (day 1, visit 0) and End of Trial (Arm A week 12 / Arm B week 16)
Reduction of EASI
To compare the number of patients with a reduction of the eczema score EASI 50.
Time frame: Arm A week 12 / Arm B week 16
Reduction in SCORAD (Scoring atopic dermatitis)
The number of patients with a reduction of 50 % in SCORAD index.
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Change in pruritus score (Visual Analogue Scale)
To compare the proportion of patients with change in pruritus score (VAS) by 50 %.
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Change in IGA Score (5-point Investigator's Global Assessment)
To compare the proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score compared to baseline.
Time frame: Arm A week 12 / Arm B week 16
Serum biomarkers CCL17 and CCL22
To compare the serum biomarkers CCL17 and CCL22.
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
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Enrollment
22
SIBAmed Studienzentrum GmbH & Co KG
Leipzig, Germany
Increase in DLQI (Dermatology Life Quality Index)
To compare the proportion of patients achieving increase in DLQI by 30 %.
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Consumption of topical methylprednisolone aceponate
To evaluate the quantification of the consumption of topical methylprednisolone aceponate 0.1% in gram.
Time frame: day 1, week 4 and Arm A week 12 / Arm B week 16
Serious and non-serious adverse drug reactions
To observe any serious adverse drug reactions and non-serious adverse drug reactions.
Time frame: treatment phase (day 1 up to week 16), follow-up phase (week 20, week 24)
Gender distribution in patients with atopic dermatitis
Subgroup analyses will be performed to compare the effects of treatment with Secukinumab in male and female patients. Therefore, the recorded gender data will be used and separately analyzed for the above mentioned primary and secondary endpoints.
Time frame: study arm A week 4 and both study arms week 16