Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

Stiefel

Status and phase

Withdrawn

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: Acitretin (also called U0279)

Drug: Placebo

Biological: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00832364

114549

U0279-401

Details and patient eligibility

About

The purpose of the study is to assess the safety and efficacy of an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.

Full description

The study is being conducted in order to obtain safety and efficacy data for an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis. The subjects will be randomized to either U0279 or placebo after having been on an injectable biologic for 12 weeks previously. The subject will be on study medication for 12 weeks. The subjects must have moderate to severe Psoriasis

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects 18 years of age or older.
Surgically sterile females. Females who have had a hysterectomy or completed menopause are allowed.
Affected Body Surface Area with psoriasis of ≥10%.
Psoriasis Global Assessment rating of "moderate to severe" or "severe".
Achieved mild to moderate improvement after receiving an injectable biologic therapy for at least 12 weeks.
A PASI score of ≥ 50 and ≤75
Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed

Exclusion criteria

Understand that the sponsor can not pay for the an injectable biologic therapy during the course of the study; be willing to pay out of pocket or secure payment through their private health insurance for an injectable biologic.
History of systemic infection, or other conditions that may interfere with study evaluations or may increase risk for participation. such as, tuberculosis, human immunodeficiency virus (HIV), hepatitis; congestive heart failure or demyelinating disorder.
Used of prohibited medications or therapies