A Study of Efalizumab in Participants With Moderate to Severe Chronic Psoriasis Who Have Failed, Have a Contraindication to, or Are Intolerant of Other Systemic Therapies

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody

Study type

Interventional

Funder types

Industry

Identifiers

NCT00249808

Control II Study

25300

Details and patient eligibility

About

This is a Phase IIIb/IV, open label, multicentre study of efalizumab (anti cluster of differentiation [CD] 11a recombinant human monoclonal antibody) in participants with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, and psoralen and ultraviolet A phototherapy (PUVA).

Enrollment

1,266 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Moderate to severe plaque psoriasis participants who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA
Age at least 18 years
For women of childbearing potential and for men whose partner can become pregnant, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and up to 3 months after the last dose of efalizumab
Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care
Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (efalizumab)
Discontinuation of all biologic agents (other than efalizumab) 3 months prior to receiving first dose of study drug (efalizumab)
Discontinuation of any investigational drug or treatment 3 months prior to Study Day 0 or as per washout requirements from previous protocol
No primary vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to first dose of study drug
The participant must be willing and able to comply with the protocol requirements for the duration of the study

Exclusion criteria

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
Participants who have previously been on efalizumab treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the patient can be included in this study
History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
History of opportunistic infections (eg, systemic fungal infections, parasites)
Seropositivity for human immunodeficiency virus (HIV). Participants will undergo mandatory testing at screening. Participants who are positive for HIV will be excluded
Pregnancy or breast feeding
White Blood Cell (WBC) count less than (<) 4*10^9 per liter or greater than (>) 14*10^9 per liter
Participants with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count <100*10^9 per liter
Seropositivity for hepatitis B or C virus. Participants will undergo testing at screening. Participants who are positive for hepatitis B antigen or hepatitis C antibody will be excluded
History of active tuberculosis (TB) or currently undergoing treatment for TB within one year prior to Study Day 0. Chest X-ray (within 3 months prior to Study Day 0) is required for high-risk participants. Participants with a positive chest X-ray will be excluded
Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Participants with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
Any medical condition that, in the judgment of the investigator, would jeopardize the participant's safety following exposure to study drug