A 12 week double-blind, randomised, placebo-controlled, modified dose-escalation trial to investigate safety, efficacy, and pharmacokinetics of BIRT 2584XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with moderate to severe psoriasis with a 12 week treatment extension for PASI 50 responders.
- Conditions
- 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)]MedDRA version: 8.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2005-005368-10-DE
- Lead Sponsor
- Boehringer Ingelheim GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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, male partner sterilisation, sexual abstinence, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method