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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00307437 |
The primary objective of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with moderate to severe plaque psoriasis.
Condition | Intervention | Phase |
---|---|---|
Psoriasis |
Drug: CNTO 1275 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis. |
Estimated Enrollment: | 1200 |
Study Start Date: | March 2006 |
Although numerous therapeutic options exist for the treatment of psoriasis, there is still a significant unmet medical need due to the limited effectiveness and/or significant side effect profile of current treatment options. Preclinical studies and early phase clinical studies suggest that interleukins-12 and -23, two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. CNTO 1275 is a monoclonal antibody directed against interleukins -12 and 23. This is a randomized, double blind, parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The hypothesis is that CNTO 1275 will be more effective in treatment of psoriasis than placebo, that the improvement in psoriasis will result in an improved quality of life for treated patients and that CNTO 1275 will be generally well tolerated. Patients will receive CNTO 1275, 45 or 90 mg, or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52. For subjects who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks. Patients will enter long term extension portion of the study at week 52 during which subjects will continue to receive treatment with CNTO 1275 and will be followed for a total of up to 264 weeks from the initial (week 0) administration of study agent.
The dose of CNTO 1275 will be 45 or 90 mg or placebo administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter. For subjects who partially respond to the starting regimen, the dosing interval may be adjusted to every 8 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Study ID Numbers: | CR006325 |
Study First Received: | March 24, 2006 |
Last Updated: | October 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00307437 |
Health Authority: | United States: Food and Drug Administration |
IL-12 CNTO 1275 interleukin 12 interleukin 23 IL12 CNTO1275 |
interleukin-23 IL-23 biologic Psoriasis IL23 interleukin-12 |
Interleukin-12 Skin Diseases Psoriasis Skin Diseases, Papulosquamous |