Moderate to serve atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: COSENTYX ®
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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)*, 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 comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed, 7. 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, 8. Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate. *a SX-1 CAP FEIA report = 6 months is accepted Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 trial including chronic infections, 4. Contraindications of Secukinumab by label (i.e. approval for the treatment of psoriasis in the EU – refer to point 12, 13, 16 and 17 at the bottom of this section), 5. Current severe progressive or uncontrolled disease which in the judgment of the investigator 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 a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL), 11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 20 weeks after stopping treatment. Effective contraception is defined as either: a. Barrier method: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (where available). Spermicides alone are not a barrier method of contraception and should not be used alone, The following methods are considered more effective than the barrier method and are also acceptable: b. Total abstinence: When this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception), c. Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, d. Male partner sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject, e. Use of established oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS) NOTE: Women are considered post-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 spontaneous amenorrhea with serum FSH levels >40 mIU/mL or ii. Surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. 12. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening*, 13. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit* (a report = 6 months is also accepted), 14. History of alcohol or drug abuse within 1 year of the screening visit, 15. Planned major surgic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate and demonstrate the efficacy of secukinumab in patients with atopic dermatitis based on the reduction of the eczema score EASI 50 at week 4 (visit 4).;Secondary Objective: To compare the: *Proportion of patients with a reduction of eczema score EASI 50 at baseline and at EoT *Proportion of patients with change in pruritus score (VAS) by 50 % at visit 4 between verum and placebo and at baseline and EoT *Proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score at EoT as compared to day 1 *Serum biomarkers CCL17 and CCL22 at visit 4 between verum and placebo and at day 1 and EoT *Proportion of patients achieving increase in DLQI by 30 % at visit 4 between verum and placebo and at day 1 and EoT *Quantification of consumption of topical methylprednisolone aceponat 0.1% or prednicarbate in gram at visit 4 between verum and placebo *Quantification of consumption of topical methylprednisolone aceponat 0.1% or prednicarbate in gram at day 1 and EoT *Any serious- and non-serious adverse drug reaction *Number of missing days at work from day 1 to visit 4 *Efficacy in male in female after 4 weeks and at EoT ;Primary end point(s): The primary endpoint is defined by the proportion of patients with a reduction of the eczema score EASI of at least 50 % (EASI 50) at week 4 (visit 4). The proportions are then compared between study arms. ;Timepoint(s) of evaluation of this end point: 6 months after Last Patient Last Visit (LPLV) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To compare the proportion of patients with a reduction of the eczema score EASI 50 at EoT (study arm A, visit 9; study arm B, visit 10). • To compare the number of patients with a reduction of the eczema score EASI 50 at EoT (study arm A, visit 9; study arm B, visit 10) • The number of patients with a reduction of 50 % in SCORAD index at baseline (day 1, visit 0), week 4 (visit 4) and EoT. • To compare the proportion of patients with change in pruritus score (VAS) by 50 % at baseline (day 1, visit 0), 4 (week 4) and EoT (study arm A, visit 9; study arm B, visit 10). • To compare the proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score at EoT (study arm A, visit 9; study arm B, visit 10) as compared to Baseline. • To compare the serum biomarkers CCL17 and CCL22 at baseline (day 1, visit 0) and at week 4 (visit 4) and EoT (study arm A, visit 9; study arm B, visit 10). • To compare the serum biomarkers CCL17 and CCL22 at baseline (day 1, visit 0) and EoT (study arm A, visit 9; study arm B, visit 10) as an optional assessment. • To compare the serum biomarkers CCL17 and CCL22 at baseline (day 1, visit 0) and EoS (week 24, visit 12) as an optional assessment. • To compare the proportion of patients achieving increase in DLQI by 30 % at baseline (day 1, visit 0), week 4 (visit 4) and EoT (study arm A, visit 9; study arm B, visit 10). • To evaluate the quantification of the consumption of topical corticosteroid drug (methylprednisolone aceponat 0.1% or prednicarbate) in gram at baseline (day 1, visit 0), week 4 (visit 4) and EoT (study arm A, visit 9; study arm B, visit 10). • To observe any serious adverse drug reactions and non-serious adverse drug reactions. • To compare the efficacy of Secukinumab (primary and secondary endpoints as described above) in male and female patients with atopic dermatitis after 4 weeks and at EOT. (study arm A, visit 4 and both study | — |
Countries
Germany
Contacts
Public ContactMedical Consulting
GWT-TUD GmbH
Outcome results
None listed