An international study to evaluate the efficacy, tolerability, and safety of2 doses of ACT-128800, an investigational drug tested in patient withpsoriasis, when the drug is given up to 28 weeks and as compared to aplacebo.
- Conditions
- Moderate to severe chronic plaque psoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2010-019283-36-AT
- Lead Sponsor
- ACTELION Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
• Adult males and females aged 18 to 60 years (inclusive) with moderate to severe plaque psoriasis who require systemic treatment.
• Patients achieving at least PASI50 at Week 16 are eligible to continue participating in the study up to week 28 (maintenance period).
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 320
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
• Systemic or topical treatments for psoriasis other than emollients.
• Ongoing bacterial, viral or fungal infections.
• History or presence of malignancy.
• Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate at Week 16 (the end of the induction period) the efficacy of at least one of two doses of ACT 128800 compared to placebo in patients with moderate to severe chronic plaque psoriasis based on the proportion of patients with at least 75% improvement of Psoriasis Area and Severity Index (PASI) from baseline to Week 16.;Secondary Objective: To assess at Week 16 (end of the induction period) the efficacy of two doses of ACT 128800 compared to placebo based on the improvement of Physician’s global assessment (PGA) from baseline to Week 16.;Primary end point(s): Primary efficacy endpoint:<br>Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.<br>;Timepoint(s) of evaluation of this end point: Primary efficacy endpoint is evaluated at Week 16.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of patients with Clear or Almost clear on Physican Global<br>Assessment (PGA) at week 16.;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoint is evaluated at Week 16.