Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00442650
First received: February 28, 2007
Last updated: July 30, 2014
Last verified: March 2009

February 28, 2007
July 30, 2014
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Complete list of historical versions of study NCT00442650 on ClinicalTrials.gov Archive Site
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Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis
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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.

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Moderate to Severe Psoriasis
Drug: Efalizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  1. Signed informed consent
  2. Plaque psoriasis covering ³10% of total BSA
  3. Diagnosis of plaque psoriasis for at least 6 months
  4. A minimum PASI score of 12.0 at screening
  5. In the opinion of the investigator, candidate for systemic therapy for psoriasis
  6. Body weight of £120 kg
  7. 18 to 75 years old
  8. 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).
  9. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
  10. Willingness to enter Study

Exclusion Criteria:

  1. Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
  2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies or fusion proteins that contain an Ig Fc region
  3. Clinically significant psoriasis flare during screening or at the time of enrollment that would necessitate immediate relief for that patient
  4. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
  5. History of opportunistic infections (e.g., systemic fungal infections, parasites)
  6. Seropositivity for human immunodeficiency virus (HIV)

    • Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
  7. Pregnancy or lactation
  8. WBC count <4000/mL or >14,000/mL
  9. Patients with an history of clinically significant thrombocytopenia, bleeding disorder or a platelet count <100,000/mL
  10. 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.
  11. Hepatic enzymes ³3 times the upper limit of normal
  12. 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.
  13. Presence of malignancy within the past 5 years, including lymphoproliferative disorders

    • Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled even if it is less than 5 years.
  14. Previous treatment with efalizumab (anti-CD11a)
  15. Diagnosis of hepatic cirrhosis, regardless of cause or severity
  16. Serum creatinine ³2 times the upper limit of normal
  17. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
  18. History of substance abuse (e.g. narcotics, alcohol) within the last 5 years
  19. Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug

    Note: Restrictions and/or directions apply to the following treatments during specified time periods prior to initial study drug administration and during the study:

  20. Systemic therapy for psoriasis within 28 days prior to Study Day 0
  21. Systemic immunosuppressive drugs for other indications within 28 days prior to Study Day 0
  22. Topical therapies for psoriasis within 14 days prior to Study Day 0
  23. Live or killed virus or bacteria vaccines within 14 days prior to Study Day 0
  24. Other vaccines or allergy desensitization within 14 days prior to study Day 0
  25. Other experimental drugs or treatments within 28 days or five half lives, whichever is longer, prior to Day 0
  26. Use of b Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant from Day -28 throughout the study)
Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00442650
25030
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Merck KGaA
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Study Director: Daiana Licu, MD Merck Serono International SA
Merck KGaA
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP