E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque-type psoriasis (defined as involving ≥ 10% body surface area, with minimum disease severity PASI ≥ 10 and with static PGA of at least moderate (score of at least 3)] |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | low |
E.1.2 | Classification code | 10050576 |
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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 proposed study is a phase 2a/b international multicentre clinical trial. The general aim of this study is to investigate the safety and efficacy (clinical proof of concept) of three different doses (100 mg, 300 mg, or 500 mg) of BIRT 2584 XX tablets administered orally once daily compared to placebo tablets for the treatment of patients with moderate to severe plaque-type psoriasis patients who are candidates for systemic treatment or phototherapy. This study may also provide dose-finding information for future pivotal studies. |
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E.2.2 | Secondary objectives of the trial |
- Durability of remission/response, and the occurrence of any relapse or rebound during the treatment with study drug and after the end of treatment will be assessed in an 8 weeks follow-up period. - In this phase II study the sPGA will be used as a secondary efficacy endpoint with the intent to validate it for use as a primary endpoint in phase III trials. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 18 to 75, males or females 2. Patients with stable moderate to severe plaque-type psoriasis involving ≥ 10% body surface area, with minimum disease severity PASI ≥ 10 and with static PGA of at least moderate (score of at least 3) at screening visit 3. Psoriasis disease duration of at least 6 months prior to screening 4. Patients must be candidates for systemic psoriasis treatment or phototherapy 5. Patient must give informed consent and sign an approved consent form prior to any study procedures, including wash out of prohibited medications
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E.4 | Principal exclusion criteria |
1. Patients with primary guttatae, erythrodermic, or pustular psoriasis 2. Patients who have previously discontinued efalizumab treatment due to lack of efficacy 3. Patients using treatments that could interfere with the primary endpoint of the study 4. Patients on treatment with warfarin, paracetamol (acetaminophen), some NSAIDs, some antidepressants, medications known to induce or inhibit CYP3A4, or any other concomitant medication where potential drug-drug interactions with BIRT 2584 XX could either result in decreased efficacy or an unacceptable benefit-risk assessment, and where replacement of that concomitant medication with a safe equivalent drug is not possible 5. Patients with active liver disease or history of any significant liver disease. 6. Any clinically significant illness or unstable disease which according to investigator judgement may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate. 7.Patient with serum creatinine and/or white blood cell count >1.5 x ULN at screening 8. Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening 9. Abnormal values of other laboratory parameters at screening that would define a clinically significant disease as described in # 6 above 10. Positive testing at screening, or history of HIV or hepatitis B or hepatitis C, or any serious infection in the past 3 months prior to screening 11. History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma 12. Patients with the following findings at the screening visit that could interfere with cardiac repolarisation 13. History of drug or alcohol abuse within the past two years 14. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active woman who: - is pregnant or nursing - is of child bearing potential and not practicing acceptable methods of birth control, or does not plan to continue practising an acceptable method throughout the study (acceptable methods of birth control include surgical sterilisation, intrauterine devices, double barrier, male partner sterilisation, but not hormonal contraceptives) 15. Patient not willing to avoid excess sun exposure during the trial duration 16. Patients who have taken an investigational drug, within the last 4 weeks or 5 half lives prior to randomisation 17. Known allergy to BIRT 2584 XX or to the excipients used for tablet formulation 18. Body mass index > 34 kg/m2 at screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the achievement of at least 75% reduction from baseline PASI score (PASI75) at 12 weeks. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 |
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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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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End of trial is the last visit of the last subject undergoing the trial |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |