NCT01208090CompletedPhase 2
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis
Actelion67 sites in 10 countries326 target enrollmentStarted: October 31, 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 326
- Locations
- 67
- Primary Endpoint
- Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Study Overview
Brief Summary
This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.
Exclusion Criteria
- •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.
Arms & Interventions
Investigational drug - Dose 1
Experimental
Intervention: ACT-128800 (Drug)
Investigational drug - Dose 2
Experimental
Intervention: ACT-128800 (Drug)
Matching placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Time Frame: Baseline to week 16
Secondary Outcomes
- Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.(Baseline to week 16)
Investigators
Study Sites (67)
Loading locations...
Similar Trials
Completed
Phase 2
ACT-128800 in PsoriasisPlaque PsoriasisNCT00852670Actelion66
Completed
Phase 2
Study of ACT-129968 in Adult Patients With Seasonal Allergic RhinitisSeasonal Allergic RhinitisNCT01241214Idorsia Pharmaceuticals Ltd.579
Completed
Phase 2
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisNCT01006265Actelion464
Completed
Phase 3
Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic RhinitisSeasonal Allergic RhinitisNCT01484119Idorsia Pharmaceuticals Ltd.630
Completed
Phase 1
Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasing Doses and to Examine the Effects of ACT-1004-1239 on the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-1004-1239HealthyNCT04286750Idorsia Pharmaceuticals Ltd.50