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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

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ClinicalTrials.gov Identifier: NCT00249808
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1266 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Efalizumab in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Have Failed to Respond to, or Who Have a Contraindication to, or Are Intolerant to Other Systemic Therapies Including Ciclosporin, Methotrexate and PUVA
Actual Study Start Date : December 13, 2004
Actual Primary Completion Date : January 25, 2007
Actual Study Completion Date : January 25, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Efalizumab Drug: Efalizumab - anti-CD11a recombinant human monoclonal antibody
Participants will receive efalizumab 1.0 milligram per kilogram (mg/kg) (with an initial conditioning dose of 0.7 mg/kg) once weekly by subcutaneous injection for 12 weeks (first treatment [FT]). Depending on the response at Week 12, participants could receive additional 8 to 12 weekly injections of efalizumab 1.0 mg/kg.




Primary Outcome Measures :
  1. Percentage of Participants With Physician's Global Assessment (PGA) Ratings of Good or Better (FT) [ Time Frame: Week 12 ]
    The PGA assesses the global response of all psoriatic lesions to therapy by comparing the participant's present condition to baseline. PGA response includes: Cleared (100 percent [%] improvement; remission of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Excellent (75% to 99% improvement of all clinical signs and symptoms, except for residual manifestations such as mild erythema); Good (50% to 74% improvement of all clinical signs and symptoms); Fair (25% to 49% improvement of all clinical signs and symptoms); Slight (1% to 24% improvement of all clinical signs and symptoms); Unchanged (clinical signs and symptoms unchanged); Worse (clinical signs and symptoms deteriorated). Percentage of participants with PGA ratings of Good or Better (i.e, Good, Excellent or Cleared) are reported.


Secondary Outcome Measures :
  1. Percentage of Participants With Psoriasis Rebound [ Time Frame: Up to 8 weeks after end of FT (up to Week 20) ]
    Rebound was defined as worsening of disease as assessed by Psoriasis Area and Severity Index (PASI) score >125% of baseline or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 2 months of stopping therapy. PASI is an instrument used to assess the extent of cutaneous psoriasis and to measure the effects of therapy. The PASI divides the body into four anatomical regions: head, trunk, upper limbs, and lower limbs. For each region, the evaluator assesses the severity of erythema, induration/thickness and scaling and determines the percentage of the region affected by disease. A numerical PASI score is derived that evaluates the severity of symptoms in terms of the total body surface area affected. Total PASI score ranges from 0 to 72, with higher scores indicating more severe disease.

  2. Percentage of Participants With Psoriasis Exacerbation [ Time Frame: During study (40 weeks) ]
    Exacerbation was defined as disease worsening either during or after treatment which was more inflammatory in nature compared to baseline and occurred either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249808


Locations
United Kingdom
Medical Information
Feltham, United Kingdom
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

Publications of Results:
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00249808     History of Changes
Other Study ID Numbers: 25300
Control II Study
First Posted: November 7, 2005    Key Record Dates
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018
Last Verified: August 2017

Keywords provided by Merck KGaA, Darmstadt, Germany:
Candidates for systemic therapy for psoriasis

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