E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic plaque-type psoriasis (psoriasis vulgaris) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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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 of the trial is the evaluation of the safety and efficacy of topical Bimosiamose 5% Cream for the treatment of male and postmenopausal or sterile female patients with mild to moderate chronic plaque type psoriasis. Clinical efficacy will be assessed by the improvement from Baseline of modified Psoriasis Area and Severity Index by 50% (mPASI 50, PASI excluding the scalp) at Day 112 (End of Treatment) in patients treated with Bimosiamose 5% Cream compared with Placebo Cream. |
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E.2.2 | Secondary objectives of the trial |
• To assess the global effect of Bimosiamose treatment on psoriasis over the study period • To assess the induration, erythema, scaling and pruritus in two Index Lesions over the study period • To assess the time to effective treatment • To determine patient satisfaction with Bimosiamose treatment • To assess the potential for rebound effects of treatment
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
There is one sub-study with two parts and with the same study title. The sub-study is part of the study protocol, version 12 from September 12, 2008. The objectives are:
Sub-Study Part A, conducted in one center in Berlin (Charité): •To assess the histological and immunohistological changes and changes in the expression profile of psoriasis relevant mediators in skin biopsies •To assess the changes of psoriasis relevant mediators in blood
Sub-Study Part B, conducted in the center of Magdeburg: •To assess topoproteome changes in skin biopsies
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E.3 | Principal inclusion criteria |
All of the following criteria have to be met for inclusion of a patient with chronic plaque type psoriasis into the study: 1. Male patients or postmenopausal female patients with amenorrhea of at least twelve consecutive months duration prior to screening (medical certificate by gynecologist) or sterile female patients with documented hysterectomy or tubal ligation 2. PASI score of 5-15 (plaques must not be exclusively over the knees and elbows) and a PGA of ≤ moderate 3. At least 18 years of age 4. Time and ability to complete the study and comply with instructions 5. Written informed consent
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E.4 | Principal exclusion criteria |
Patients are to be excluded from the study when one or more of the following conditions are met: 1. Active skin infection or other skin conditions that may influence the evaluation of the psoriatic lesions e.g. eczema 2. More than 20% Body Surface Area (BSA) affected by psoriasis (excluding palmar or plantar located) 3. Use of anti-psoriasis medication or treatments below (except emollients): a. Retinoid, calcipotriene, coal tar or anthralin ≤14 days prior to Baseline b. Systemic and topical corticosteroids, fumarate, methotrexate, cyclosporine or systemic retinoids, ≤30 days prior to Baseline c. Prolonged sun exposure ≤30 days prior to Baseline d. Laser therapy or Photodynamic therapy (or PUVA) ≤30 days prior to Baseline e. Etanercept, efalizumab, infliximab or adalimumab ≤90 days prior to Baseline f. Alefacept or IL-12/23 inhibitors ≤180 days prior to Baseline g. On lithium, antimalarials, beta blockers or ACE inhibitors unless the dose has been stable for 60 days prior to entry and is planned to remain stable during the study 4. Clinical study participation with any investigational drug less than 90 days prior to study entry or planning to receive an investigational drug during the study period 5. Previous treatment with Bimosiamose 6. Known allergy to any of the components of Bimosiamose 5% Cream 7. Cancerous or pre-cancerous lesions 8. Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to stay in the study for 140 days because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable; or patients who have a concomitant condition that might confuse or confound study assessments) 9. Severe allergies manifested by a history of anaphylaxis or a history of multiple allergies 10. Receiving immunosuppressive therapy 11. Positive results on urine drug screen 12. Current signs of alcohol abuse 13. The patient has laboratory test results that indicates acute or chronic infectious hepatitis A, B or C or an infection with human immunodeficiency virus (HIV) 14. gamma-GT ≥3 times the upper limit of normal 15. Platelet count ≥10% below the lower limit of normal 16. Subject is institutionalized because of legal or regulatory order
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement from Baseline of modified Psoriasis Area and Severity Index by 50% (mPASI 50) at week 16 (End of Treatment) in patients treated with Bimosiamose 5% Cream compared with Placebo Cream. mPASI is the full PASI score minus the scalp component. |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
substudy part A: Analysis of Psoriasis relevant mediators; substudy part B: Topoproteome analysis |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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.8.3 |
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 | 12 |
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 | Information not present in EudraCT |
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
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The treatment period will take 16 weeks, the follow-up period further 4 weeks. The end of the trial is the last visit of the last patient undergoing the trial (last patient out). |
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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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |