Double-blind, Randomised, Placebo-controlled Trial Investigating BIRT 2584 XX in Patients With Moderate/Severe Psoriasis
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The purpose of this clinical study is to determine the effectiveness, pharmacokinetics and safety of several doses of BIRT 2584 XX (100mg, 300mg and 500mg) taken once daily in the treatment of moderate to severe plaque-type psoriasis. This new medicine will be compared to a so-called placebo medicine over 12 weeks with a 12 weeks treatment extension possible.
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
Study Start Date :
Actual Primary Completion Date :
Resource links provided by the National Library of Medicine
Achievement of > 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score (PASI75 ) at 12 weeks [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
Other PASI assessments, NPF Psoriasis Score Static Psoriasis Global Assessment (sPGA), Discontinuations of therapy due to lack of efficacy, Relapse and rebound, Dermatology Life Quality Index, Pain Visual Analog Scale for psoriatic arthritis [ Time Frame: 12 and 24 weeks ]
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age 18 to 75, males or females
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
Psoriasis disease duration of at least 6 months prior to screening
Patients must be candidates for systemic psoriasis treatment or phototherapy
Patient must give informed consent and sign an approved consent form prior to any study procedures, including wash out of prohibited medications (Patients participating in the PK sub-study will sign an additional consent form. Refusal to participate in the sub-study will not exclude from participation in the main trial)
Patients with primary guttatae, erythrodermic, or pustular psoriasis
Patients who have previously discontinued efalizumab treatment due to lack of efficacy
Patients using treatments that could interfere with the primary endpoint of the study (cf. protocol section 188.8.131.52)
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 (cf. protocol section 184.108.40.206 and the Investigator Site File).
Patients with active liver disease or history of any significant liver disease.
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 patients ability to participate.
Patient with serum creatinine and/or white blood cell count >1.5 x ULN at screening.
(Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
Abnormal values of other laboratory parameters at screening that would define a clinically significant disease as described in # 6 above (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
Positive testing at screening, or history of HIV or hepatitis B or hepatitis C, or any serious infection (requiring hospitalisation or parenteral antibiotic therapy) in the past 3 months prior to screening
History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
Patients with the following findings at the screening visit that could interfere with cardiac repolarisation:
marked baseline prolongation of QT/QTc interval as measured on ECG (e.g. QTc interval >450ms);
history of additional risk factors for Torsade de pointe (e.g. heart failure, - hypokalemia, family history of long QT syndrome);
use of concomitant medications that prolong the QT/QTc interval
History of drug or alcohol abuse within the past two years
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**) [A negative serum pregnancy test at screening (Visit 1) and a negative urine test prior to randomisation (Visit 2) are required]
Patient not willing to avoid excess sun exposure during the trial duration
Patients who have taken an investigational drug, within the last 4 weeks or 5 half lives (which ever is greater) prior to randomisation [Patients who have been treated with any investigational antibody or fusion protein within the past 12 weeks before randomisation are excluded]
Known allergy to BIRT 2584 XX or to the excipients used for tablet formulation