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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00292396 |
The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis
Condition | Intervention | Phase |
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Psoriasis |
Drug: Anti IL-12 monoclonal antibody/ABT-874 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
Enrollment: | 180 |
Study Start Date: | November 2005 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
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Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
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2: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
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Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
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3: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
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Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
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4: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
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Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
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5: Active Comparator
Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
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Drug: Anti IL-12 monoclonal antibody/ABT-874
Please see Arm Description for intervention description and details.
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6: Placebo Comparator
placebo, 12 doses
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Drug: placebo
12 doses
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Nicky Mayber ) |
Study ID Numbers: | M05-736 |
Study First Received: | February 14, 2006 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00292396 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Interleukin-12 Immunologic Factors |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous Immunoglobulins |
Antibodies, Monoclonal Immunologic Factors Skin Diseases Psoriasis |
Physiological Effects of Drugs Skin Diseases, Papulosquamous Pharmacologic Actions |