Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis (NCT03568136) | Clinical Trial Compass
CompletedPhase 2
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
Germany22 participantsStarted 2018-09-18
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Atopic dermatitis (intrinsic disease without IgE mediated sensitization defined by negative history and negative SX-1 CAP FEIA or extrinsic disease defined by positive history and / or positive SX-1 CAP FEIA),
✓. SCORAD index score ≥ 25,
✓. EASI ≥ 16,
✓. Male and female patients at the age of 18 to 85 years,
✓. Signed Informed Consent,
✓. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed,
✓. Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination,
✓. Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
Exclusion criteria
✕. Other inflammatory skin disease than atopic dermatitis,
✕. Use of cyclosporine, azathioprine, mycophenolate \[wash-out period of 4 weeks\]; Phototherapy (PUVA, NB-UVB, UVA1; \[wash-out period of 2 weeks\]), Dupilumab (Dupixent®; \[wash-out period of 12 weeks\])
✕. Subjects expected to be exposed to an undue safety risk if participating in the trial including chronic infections,
✕. Contraindications of Secukinumab by label (i.e. approval for the treatment of psoriasis in the EU - refer to point 14 - 16 at the bottom of this section),
✕. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial,
✕. Plans for administration of live vaccines during the study period,