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A Study of the Safety and Efficacy of CNTO 1275 in Subjects With Moderate to Severe Psoriasis
This study is ongoing, but not recruiting participants.
Study NCT00307437   Information provided by Centocor, Inc.
First Received: March 24, 2006   Last Updated: March 26, 2009   History of Changes

March 24, 2006
March 26, 2009
February 2006
December 2006   (final data collection date for primary outcome measure)
The primary endpoint is the proportion of subjects who achieve >= 75% improvement in the psoriasis area-and-severity index from baseline at Week 12.
Same as current
Complete list of historical versions of study NCT00307437 on ClinicalTrials.gov Archive Site
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.
Same as current
 
A Study of the Safety and Efficacy of CNTO 1275 in Subjects With Moderate to Severe Psoriasis
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.

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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Psoriasis
Drug: CNTO 1275
 
Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, Guzzo C, Hsu MC, Wang Y, Li S, Dooley LT, Reich K; PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008 May 17;371(9625):1675-84.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1200
 
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00307437
 
CR006325
Centocor, Inc.
 
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP