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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00249808
First received: November 4, 2005
Last updated: August 5, 2014
Last verified: March 2009
  Purpose

Phase IIIb , open-label, multi-centre study in patients receiving efalizumab 1mg/kg/week for 12 weeks.

At anytime during the first 12 weeks, non-responding or worsening patients will discontinue efalizumab and enter a 12-week treatment period with other approved antipsoriasis therapies.

Objectives:

  • To establish safe psoriasis control of moderate to severe chronic plaque psoriasis with efalizumab in patients who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate and PUVA.
  • To evaluate the management of psoriasis events namely rebound and exacerbation, in patients while on Efalizumab or subsequent to its discontinuation

Condition Intervention Phase
Psoriasis
Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Open Label Phase IIIb Study of Subcutaneously Admin. Efalizumab (Adult Patients) With Moderate to Severe Chronic Psoriasis Failed to Respond to, or Have a Contraindication to, or Are Intolerant of Other Systemic Therapies Incl. Cyclosporine, Methotrexate and PUVA.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • To establish control of moderate to severe chronic plaque psoriasis with efalizumab in patients who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the management of psoriasis events, namely rebound and exacerbation (psoriasis flare-ups) in patients while i) on efalizumab therapy and ii) subsequent to its discontinuation. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1266
Study Start Date: December 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody
Each subject will receive 12 doses of 1 mg/kg/week during a period of 12 weeks. Depending on the response at 12 weeks patients might receive additional 8 to 12 weekly injections at 1.0 mg/kg/week.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe plaque psoriasis patients who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA.

OR

  • 18 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 and up to 3 months after the last dose of efalizumab.
  • Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study.
  • 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 patient 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 PUVA, UVB treatment 28 days prior to commencement of 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.
  • Treatment regimens of b blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to first dose of study drug (efalizumab).
  • The patient 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.
  • Patients 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). Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
  • Pregnancy or breast feeding.
  • WBC count <4000/L or >14,000/L.
  • Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count <100,000 cells/L.
  • Seropositivity for hepatitis B or C virus. Patients will undergo testing at screening. Patients 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 SD0) is required for high-risk patients. Patients with a positive chest X-ray will be excluded.
  • 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.
  • 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 patient's safety following exposure to study drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249808

Locations
United Kingdom
Medical Information
Feltham, United Kingdom
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Daiana Licu, MD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Maria Koutsopoulou, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00249808     History of Changes
Other Study ID Numbers: 25300, Control II Study
Study First Received: November 4, 2005
Last Updated: August 5, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Merck KGaA:
Candidates for systemic therapy for psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014