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A Study of the Safety and Efficacy of CNTO 1275 in Subjects With Moderate to Severe Psoriasis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Centocor, Inc..   Recruitment status was  Active, not recruiting

First Received on March 24, 2006.   Last Updated on March 26, 2009   History of Changes
Sponsor: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00307437
  Purpose

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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The primary endpoint is the proportion of subjects who achieve >= 75% improvement in the psoriasis area-and-severity index from baseline at Week 12.

Secondary Outcome Measures:
  • Major secondary endpoints are the proportions of subjects with clear or minimal disease at Week 12 by Physician Global Assessment, the improvement in the Dermatology Life Quality Index, and the evaluation of dosing interval adjustment.

Estimated Enrollment: 1200
Study Start Date: February 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Plaque-type psoriasis diagnosed >= 6 months prior
  • Plaque-type psoriasis covering at least 10% of total body surface areas
  • Psoriasis area-and-severity index score of >=12 at screening and baseline
  • Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
  • Women of childbearing potential and all men must agree to use adequate birth control measures throughout the trials and for 12 months following the last injection of study agent
  • Have no history of latent or active TB

Exclusion Criteria:

  • Currently have nonplaque forms of psoriasis or drug-induced psoriasis
  • Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
  • Patients who have used any therapeutic agent targeted at reducing IL-12 or IL-23
  • Patients who have had a BCG vaccination within the previous 12 months prior to screening
  • Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months prior to screening
  • Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
  • Patients known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
  • Patients participating in another trial using an investigational agent or procedure
  • Systemic immunosuppressants within 4 weeks of the first administration of study agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307437

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided by Centocor, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00307437     History of Changes
Other Study ID Numbers: CR006325
Study First Received: March 24, 2006
Last Updated: March 26, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
interleukin 23
IL-12
interleukin-12
interleukin-23
CNTO1275
biologic
Psoriasis
CNTO 1275
IL23
interleukin 12
IL-23
IL12

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012