Plaque psoriasis diagnosed for at least 12 months with or without psoriatic arthritis
Conditions
Interventions
Product Code: AEB071C
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women, between 18 and 75 years of age - Plaque psoriasis diagnosed for at least 12 months (with or without presence of psoriatic arthritis as a comorbidity) - PASI score of 10 or greater - Total Body Surface Area (BSA) of 10% or greater affected by plaque psoriasis - Investigator’s Global Assessment (IGA) score of 3 or greater 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
Exclusion criteria
Exclusion criteria: - Hematological abnormalities - Heart rate 90 bpm - Family history of long QT syndrome or QTcF > 470 msec - History of cardiac arrhythmia, conduction abnormality, myocardial infarction, uncontrolled or unstable angina pectoris, congestive heart failure, percutaneous coronary intervention, syncope - History of stroke, transient ischemic attack (TIA) - History of major gastrointestinal surgery - Serum potassium level outside normal range - Known to be immunocompromised - Abnormalities in liver function tests - Active systemic infections other than common cold - History of malignancy - Current other forms of psoriasis - Use of prohibited treatments/medications - Pregnant or nursing (lactating) women - Women of childbearing potential, unless they are using highly effective methods of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate efficacy (as assessed by PASI response or PASI75) of AEB071 in patients with plaque psoriasis as a function of treatment dose (50 mg BID, 100 mg OD, 100 mg BID, 200 mg OD, and 200 mg BID) and treatment duration (of up to 12 weeks).;Secondary Objective: (1) to evaluate overall safety of AEB071 in the Treatment Period and Follow-up Periods as assessed by ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs; (2) to evaluate the efficacy of AEB071 compared with placebo within the Treatment Period as measured by PASI, and Investigator’s Global Assessment (IGA) of psoriasis; and (3) to evaluate the effect of treatment withdrawal and disease recurrence in the treatment-free Follow-up Period.;Primary end point(s): - The primary efficacy variable will be Treatment response defined as achieving PASI 75. - Secondary efficacy variables will be overall change in PASI score during the Treatment Period and treatment success in the Treatment Period based on IGA score. - Exploratory efficacy variables will be PASI, IGA, PASI 50, PASI 75 and PASI 90 at each visit, time to rebound, time to relapse, duration of remission, duration of treatment response, finger nail changes, markers of systemic inflammation (levels of C-reactive protein [CRP]); and patient’s assessments of: psoriasis, pruritus, psoriatic arthritis, psoriasis specific Quality of Life (PSORIQoL), functional disability (DLQI); and the generic health status (SF-36) | — |
Countries
Austria, Belgium, Germany, Italy
Outcome results
None listed