Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis

NCT00442650 | Completed Phase 3

• 1 other identifier: 25030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Multicentre, open label, phase III study. Subjects with moderate to severe psoriasis were given efalizumab subcutaneously once per week for the 12-week treatment period. Assessments involved physical examination, disease activity assessments, clinical laboratory tests (haematology, blood chemistry and standard urinalysis), evaluation of the Psoriasis Area and Severity Index (PASI), the Physician's Global Assessment (PGA), the Patient's Global Psoriasis Assessment (PGPA), the SF-36 Health Survey and psoriatic body surface area (BSA). The 12-week treatment period was followed by a 12-week follow-up (FU) period, during which other antipsoriatic medications were allowed. The same assessments were also performed in the 12-week FU period.

Conditions

Moderate to Severe Psoriasis

Interventions

Efalizumab DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Plaque psoriasis covering ³10% of total BSA
• Diagnosis of plaque psoriasis for at least 6 months
• A minimum PASI score of 12.0 at screening
• In the opinion of the investigator, candidate for systemic therapy for psoriasis
• Body weight of £120 kg
• to 75 years old
• 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 (including the FU period).
• Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
• Willingness to enter Study

You may not qualify if:

• Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
• History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies or fusion proteins that contain an Ig Fc region
• Clinically significant psoriasis flare during screening or at the time of enrollment that would necessitate immediate relief for that patient
• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• History of opportunistic infections (e.g., systemic fungal infections, parasites)
• Seropositivity for human immunodeficiency virus (HIV)
• Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
• Pregnancy or lactation
• WBC count \<4000/mL or \>14,000/mL
• Patients with an history of clinically significant thrombocytopenia, bleeding disorder or a platelet count \<100,000/mL
• Seropositivity for hepatitis B or C virus
• Patients will undergo testing during screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
• Hepatic enzymes ³3 times the upper limit of normal
• History of active tuberculosis (TB) or currently undergoing treatment for TB
• Chest X-ray within 3 months of Day 0 is required for all patients. Patients with a positive chest X-ray consistent with TB infection will be excluded.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Merck Serono Medical Information Office

Geneva, Switzerland

Location

Related Publications (1)

• Tsai TF, Liu MT, Liao YH, Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study. J Eur Acad Dermatol Venereol. 2008 Mar;22(3):345-52. doi: 10.1111/j.1468-3083.2007.02430.x. Epub 2007 Nov 14.

  PMID: 18005021 RESULT

MeSH Terms

Interventions

efalizumab

Study Officials

• Daiana Licu, MD

  Merck Serono International SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 2, 2007
• Study Start: January 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: November 21, 2016

Record last verified: 2009-03

Locations

CH (1)