ACT-128800 in Psoriasis

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: ACT-128800

Study type: Interventional

Funder types: Industry

Identifiers

NCT00852670

AC-058A200

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified.

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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66 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: ACT-128800

B

Placebo Comparator group

Treatment:

Drug: Placebo