Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

AbbVie

Status and phase

Completed

Phase 3

Conditions

Plaque Psoriasis

Treatments

Biological: Adalimumab

Biological: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01646073

M13-606

Details and patient eligibility

About

A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

Full description

The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

Enrollment

425 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of psoriasis for at least 6 months.
Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.

Exclusion criteria

Diagnosis of other active skin diseases or skin infections.
Participant has known hypersensitivity to adalimumab or it excipients.
Participant has chronic recurring infections or active tuberculosis.
Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
Participant is known to have immune deficiency or is immunocompromised.