ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: ACT-128800

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208090

AC-058A201

Details and patient eligibility

About

This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.

Enrollment: 326 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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326 participants in 3 patient groups, including a placebo group

Investigational drug - Dose 1

Experimental group

Treatment:

Drug: ACT-128800

Investigational drug - Dose 2

Experimental group

Treatment:

Drug: ACT-128800

Matching placebo

Placebo Comparator group

Treatment:

Drug: Placebo