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

Inclusion Criteria:

1. Atopic dermatitis (intrinsic disease without IgE mediated sensitization defined bynegative history and negative SX-1 CAP FEIA or extrinsic disease defined by positivehistory and / or positive SX-1 CAP FEIA),
2. SCORAD index score ≥ 25,
3. EASI ≥ 16,
4. Male and female patients at the age of 18 to 85 years,
5. Signed Informed Consent,
6. Subjects must be able to understand and communicate with the investigator and complywith the requirements of the study and must give a written, signed and dated informedconsent before any study related activity is performed,
7. Subject is judged to be in good general health as determined by the principalinvestigator based upon the results of medical history, laboratory profile, andphysical examination,
8. Patients with stable chronic asthma, treated with inhaled corticosteroids, will beallowed to participate.

Exclusion Criteria:

1. Other inflammatory skin disease than atopic dermatitis,
2. 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])
3. Subjects expected to be exposed to an undue safety risk if participating in the trialincluding chronic infections,
4. Contraindications of Secukinumab by label (i.e. approval for the treatment ofpsoriasis in the EU - refer to point 14 - 16 at the bottom of this section),
5. Current severe progressive or uncontrolled disease which in the judgment of theinvestigator renders the subject unsuitable for the trial,
6. Plans for administration of live vaccines during the study period,
7. Chronic infection,
8. Patients with instable chronic asthma,
9. Any chronic inflammatory bowel disease (e.g. Crohn's disease),
10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive hCG laboratory test (>10 mIU/mL),
11. Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unwilling to use effective contraception during the study and for 20 weeks after stopping treatment. Effective contraception is defined as either:
12. Barrier method: Condom or occlusive cap (diaphragm or cervical/vault caps) withspermicide (where available). Spermicides alone are not a barrier method ofcontraception and should not be used alone, The following methods are considered more effective than the barrier method andare also acceptable:
13. Total abstinence: When this is in line with the preferred and usual lifestyle ofthe subject (Periodic abstinence [e.g. calendar, ovulation, symptothermal,post-ovulation methods] and withdrawal are not acceptable methods ofcontraception),
14. Female sterilization: have had a surgical bilateral oophorectomy (with or withouthysterectomy) or tubal ligation at least six weeks before taking study treatment.In case of oophorectomy alone, only when the reproductive status of the woman hasbeen confirmed by follow up hormone level assessment,
15. Male partner sterilization (at least 6 months prior to screening). For femalesubjects on the study, the vasectomized male partner should be the sole partnerfor that subject,
16. Use of established oral, injected or implanted hormonal methods of contraception,intrauterine device (IUD) or intrauterine system (IUS) NOTE: Women are consideredpost-menopausal and not of child bearing potential if they have had: i. 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or • six months of spontaneousamenorrhea with serum FSH levels >40 mIU/mL Or ii. Surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligationat least six weeks before taking study treatment. In case of oophorectomy alone, onlywhen the reproductive status of the woman has been confirmed by follow up hormonelevel assessment is she considered not of child bearing potential.
17. History of human immunodeficiency virus (HIV) infection or positive HIV serology atscreening,
18. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at thescreening visit (a report ≤ 6 months is also accepted),
19. History of alcohol or drug abuse within 1 year of the screening visit,
20. Planned major surgical procedure during the patient's participation in this study,
21. Hypersensitivity against Secukinumab,
22. Active or reactive tuberculosis,
23. Participation in other clinical studies.