A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) response as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis - C2201
- Conditions
- Plaque psoriasis diagnosed for at least 12 months with or without psoriatic arthritisMedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2007-007160-19-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
Men and women, between 18 and 75 years of age.
Moderate to severe plaque psoriasis diagnosed for at least 12 months (with or w/o presence of psoriatic arthritis as a comorbidity) requiring systemic therapy.
PASI score of 10 or greater.
BSA of 10% or greater affected by plaque psoriasis.
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
Hematological abnormalities.
Heart rate < 50bpm or > 90bpm.
Family history of long QT syndrome or QTcF > 470msec.
History of cardiac arrhythmia, conduction abnormality, myocardial infarction, uncontrolled or unstable angina pectoris, CHF, PCI, syncope.
History of stroke, 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 (including women with bilateral tubal litigation), unless they are using highly effective methods of contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy (as assessed by PASI response) of AEB071 in patients with moderate to severe plaque psoriasis as a function of treatment dose and treatment duration.;Secondary Objective: Overall safety of AEB071 in the Treatment Period and Follow-up Period as assessed by ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs;<br><br>Efficacy of AEB071 compared with placebo within the Treatment Period as measured by PASI and Investigator’s Global Assessment (IGA) of psoriasis;<br><br>Effect of treatment withdrawal and disease recurrence in the treatment-free Follow-up Period.;Primary end point(s): Treatment response defined as achieving PASI 75.<br> <br>
- Secondary Outcome Measures
Name Time Method