| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| 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 | 10050576 |
| E.1.2 | Term | Psoriasis vulgaris |
| 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 |
| The primary objective is to evaluate the efficacy and safety of Fumaderm® in patients with moderate to severe psoriasis compared to placebo as assessed by the primary endpoints PASI 75 and/ or PGA 0 or 1 (clear or almost clear) during a 20 week treatment phase. |
|
| E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the efficacy and tolerability as assessed by:
• PASI means
• PASI 50, 75 and 90
• PGA
• CDLQI/DLQI
• NS AE/SAE and Lab values
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Signed informed consent (by patient and parents)
• Male and female patients aged 10 to 17 years, using highly effective methods of birth control if they are sexually active or may become sexually active during the study. Highly effective methods of birth control result alone or in combination in a low failure rate (less than 1% per year); e.g. intrauterine devices or hormonal contraceptives, double barrier method.
• Moderate to severe psoriasis vulgaris according rule of ten (PASI ≥10 or BSA ≥ 10 or CDLQI/DLQI ≥ 10) and the European consensus of treatment goals for moderate to severe psoriasis (i.e. special clinical situations may change mild psoriasis to moderate or to severe including involvement of e.g. visible areas of the head, genital areas or severe nail involvement) and history of psoriasis vulgaris for at least 6 months where previous, externally applied, stand-alone treatments have failed.
• Need for systemic treatment: moderate to severe forms of psoriasis vulgaris in cases where previous, externally applied, stand-alone treatments have failed.
• Weight > 30 kg
|
|
| E.4 | Principal exclusion criteria |
• Mild cases of psoriasis vulgaris, e.g. circumscribed plaque psoriasis or chronic stationary plaque psoriasis covering less than 10% of total body surface
• Psoriasis pustulosa
• Psoriasis arthritis
• Values of lymphocytes and leukocytes below the normal range
• Remaining differential blood count outside the normal range if judged as clinically significant
• Platelet count outside the normal range if judged as clinically significant
• Serum creatinine > upper limit of normal (ULN), reduced creatinine-clearance (calculated) (if the calculated creatinine-clearance is reduced with a normal serum creatinine, undertake a 12 h urine collection and re-test the creatinine clearance in this sample)
• gamma-GT or GOT or GPT > 2-fold ULN
• Proteinuria (+,++,+++)
• Systemic therapy with Fumaderm® or Fumaderm® initial prior to the study
• Systemic biologic therapy with:
o Etanercept within 3 months prior to study start (defined as date of signed ICF) or during the study
o Adalimumab, infliximab, or ustekinumab within 6 months prior to study start or during the study.
o Any prior therapy with efalizumab (Raptiva®)
• Systemic corticosteroid therapy within 1 month prior to study start or during the study
• Systemic therapy with methotrexate, ciclosporin or cytostatics within 1 month prior to study start or during the study
• Phototherapy within 1 month prior to study start or during the study
• Psoralens within 3 months prior to study start or during the study
• Systemic therapy with acitretin or other retinoids within 3 months prior to study start or during the study
• Drugs known to impair renal function 1 month prior to study start or during the study
• Other Immunosuppressive medication (e.g. azathioprine) within 1 month prior to study start or during the study
• Topical therapy with Vit. D3 analogues, dithranol, corticosteroids or any other topical treatment of psoriasis within 1 months prior to study start or during the study
• Significant medical condition in particular gastrointestinal diseases (e.g. ulcus ventriculi and ulcus duodeni) which may affect patient safety and/or drug efficacy and/or study evaluation in the opinion of the investigator, particularly any immunosuppressive state.
• Significant renal or liver disease
• Any neoplasm in the patient’s history
• Acute infections within the past 2 weeks prior to study start
• Hypersensitivity to Fumaderm®, Fumaderm® initial, any of its ingredients used in Fumaderm® and Fumaderm® initial.
• Hypersensitivity to Mannitol (replacement of active ingredients in placebo tablets)
• Hypersensitivity to acrylates, adhesives, plasters, sulfones or desiccants.
• Pregnant and/or breast-feeding female patients
• Female patients of childbearing potential who are sexually active or who may become sexually active during the study and who do not agree to use one of the following effective methods of birth control for the duration of the study: Intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), practicing abstinence, double barrier method
• Male patients who are sexually active or who may become sexually active during the study and who do not agree to use one of the following effective methods of birth control for the duration of the study: double barrier method, which means that the male patients use a condom and the female sexual partners use an effective method of birth control as listed above.
• Patient or patient’s parents are relatives, partner or employees of any member of the clinical research site personnel
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
PASI-75 and/or PGA 0 or 1 (clear or almost clear)
at week 20 Fumaderm® group compared to placebo group
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| V1 (baseline), V9 (20 weeks) |
|
| E.5.2 | Secondary end point(s) |
For the treatment period:
• PASI means
• PASI 50, 75 and 90
• PGA
• CDLQI/DLQI
• NS AE/SAE and Lab values
For the follow up period:
• PASI means
• PASI 50, 75 and 90
• PGA
• CDLQI/DLQI
• NS AE/SAE and Lab values
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
For the treatment period:
• PASI means at V1-V13*/V17**
• PASI 50, 75 and 90 at V1- V13*/V17**
• PGA at V1- V13*/V17**
• CDLQI/DLQI at V1- V13*/V17**
• NS AE/SAE and Lab values at V1- V13*/V17** will serve as endpoints for clinical safety in this study
For the follow up period:
• PASI means at V14-V16*/V18-V20**
• PASI 50, 75 and 90 at V14-V16*/V18-V20**
• PGA at V14-V16*/V18-V20**
• CDLQI/DLQI at V14-V16*/V18-V20**
• NS AE/SAE and Lab values at V14-V16*/V18-V20**
* for the Fumaderm®-Fumaderm® group
** for the Placebo-Fumaderm® group
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|
| 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 | Yes |
| 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| After W24 and interim DB-lock, the trial will be open. Pat. from placebo-group will receive Verum |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| 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 | 21 |
| 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 | Yes |
| 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
|
| last visit of last subject |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | 0 |
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