| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| chronic moderate to severe plaque type psoriasis |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10071117 |
| E.1.2 | Term | Plaque psoriasis |
| E.1.2 | System Organ Class | 100000004858 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To demonstrate the superiority of secukinumab compared to Fumaderm® in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 75 responders at week 24. |
|
| E.2.2 | Secondary objectives of the trial |
To compare efficacy of secukinumab and Fumaderm® on raw PASI and PASI 50/75/90/100 response rates at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare efficacy of secukinumab and Fumaderm® on BSA at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare efficacy of secukinumab and Fumaderm® on IGA mod. 2011 and IGA mod. 2011 0/1-response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare the effect of secukinumab and Fumaderm® on DLQI and DLQI 0/1 response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
To compare the effect of secukinumab and Fumaderm® on SF-36 response at weeks 4, 16 and 24.
To compare the effect of secukinumab and Fumaderm® on NAPSI response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator, and must give a written, signed and dated informed consent before any study related activity is performed.
2. Men or women must be at least 18 years of age at the time of screening
3. Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
4. Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
- PASI score of >10
- Affected body surface area (BSA) > 10%
- DLQI >10
5. Patients for whom topical psoriasis treatment alone is no longer sufficient. Inadequate response, intolerance or contraindication to topical psoriasis treatment must have been documented in the patient’s medical history or reported by the patient or determined by the investigator at screening.
6. Patients for whom Fumaderm® is expected to be the patient-individually optimized standard therapy under consideration of Fumaderm®, Ciclosporin, Methotrexate or phototherapy (Balneophototherapy, oral PUVA, NB-UVB) as per investigator’s discretion. |
|
| E.4 | Principal exclusion criteria |
1. Forms of psoriasis other than plaque psoriasis
2. Drug-induced psoriasis
3. Previous exposure to biologic drugs directly targeting IL-17A or IL-17RA, or prior treatmt. with Fumaderm® or other fumaric acid derivatives
4. Previous systemic treatmt. of plaque psoriasis or known contraindication for systemic therapy at baseline
5. Ongoing use of other prohibited psoriasis + non-psoriasis treatmt. Washout periods detailed in the prot. have to be adhered to. All other previous non-psoriasis concomitant treatmt. must be on a stable dose at least 4 wks. before randomization
6. Plans for admin. of live vaccines during the study period
7. Use of any other investigational drugs within 4 wks. of study drug initiation or within a period of 5 half-lives of the investigational treatmt., whichever is longer
8. Known hypersensitivity to secukinumab and/or other components of secukinumab, i.e. sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, L-methionine
9. Pats. with latex hypersensitivity
10. Known hypersensitivity to fumaric acid derivatives, or other components of Fumaderm® INITIAL/Fumaderm®
11. Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations incl. but not limited to recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening. Subjects with a positive or indeterminate QuantiFERON TB-Gold may participate in the study if further full tuberculosis work up completed at least 12 wks. prior to randomization establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatmt. must have been initiated + maintained according to local country guidelines for at least 4 wks. prior to randomization
12. Past medical history record of,or current infection with, HIV, hepatitis B or hepatitis C prior to randomization
13. Pats. with Crohn´s disease
14. Pats. with severe liver diseases
15. Pats. with severe gastrointestinal diseases incl. but not limited to ventricular + duodenal ulcers
16. Pats. with severe kidney diseases or serum creatinine above 1 x ULN. Pats. with serum creatinine above 1 x ULN may be incl. if the lab. abnormality is deemed clinically irrelevant by the investig.
17. Pats. with known hematological disease or with any of the following hematology lab results >1xULN or <1x LLN at screening: erythrocyte count, leukocyte count, lymphocyte count, monocytes, neutrophils, basophils, eosinophils, platelets, hemoglobin. Pats. with hematology lab results >1x ULN or<1x LLN may be included if the lab. abnormality is deemed clinically irrelevant by the investig.
18. Women
a. who are pregnant or breast feeding (pregnancy defined as the state of a female after conception + until the termination of gestation, confirmed by a positive hCG lab. test. Pats. with a positive hCG lab. test may participate in the study if they are postmenopausal or if further work up by a qualified physician establishes conclusively that the pat. is not pregnant + does not suffer from malignancy or any other condition that would constitute an excl. criterion.
b. who are menstruating + capable of becoming pregnant + not practicing a medically approved method of contraception (Pearl Index <1) during + up to at least 16 wks. after the end of treatmt. A neg. pregnancy test (serum) for all women is required with sufficient lead time before inclusion.
19. Underlying condition (incl., but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which in the opinion of the investig., significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
20. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases (except localized basal cell carcinoma, Bowen’s disease, actinic keratosis that have been treated with no evidence of recurrence in the past 12 wks. prior to screening; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
21. Significant medical problems, incl. but not limited to congestive heart failure (NYHA status of class III or IV)
22. Investig. discretion should be used for subjects with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders
23. Any medical or psychiatric condition which, in the investig.’s opinion, would preclude the subject from adhering to the prot. or completing the study per prot.
24. Current severe progressive or uncontrolled disease which in the judgment of the investig. renders the subject unsuitable for the trial or puts the subject at increased risk.
25. Inability or unwillingness to undergo repeated venipuncture |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint is the demonstration of the superiority of secukinumab compared to Fumaderm® in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 75 responders. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
The secondary endpoints are:
- To compare efficacy of secukinumab and Fumaderm® on raw PASI and PASI 50/75/90/100 response rates at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare efficacy of secukinumab and Fumaderm® on BSA at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare efficacy of secukinumab and Fumaderm® on IGA mod. 2011 and IGA mod. 2011 0/1-response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare the effect of secukinumab and Fumaderm® on DLQI and DLQI 0/1 response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
- To compare the effect of secukinumab and Fumaderm® on SF-36 response at weeks 4, 16 and 24.
- To compare the effect of secukinumab and Fumaderm® on NAPSI response at weeks 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| study with blinded assessment of the efficacy |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
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