Clinical trial NCT00320216: A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
CNTO 1275
Ustekinumab
Stelara
Interleukin-12
IL-12
Interleukin-23
IL-23
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.

Detailed description: This is a randomized (the study medication is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel-group, multicenter study to determine the effectiveness and safety of two different doses of CNTO 1275 administered subcutaneously one time or as multiple doses as compared with placebo in patients with moderate to severe plaque-type psoriasis (the most common type of psoriasis). The dose of CNTO 1275 will be 45 or 90 mg administered subcutaneously once or as four weekly doses. Patients who inadequately respond to their treatment may receive one additional dose. Patients will be monitored for the safety throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have had a diagnosis of plaque-type psoriasis at least 6 months
* Plaque-type psoriasis covering at least 10% of total body surface areas
* Psoriasis area-and-severity index score of 12 or greater
* 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
* Have no history of latent or active tuberculosis

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 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
* Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
* Patients known to be infected with human immunodeficiency virus, 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
* Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)

Primary outcomes:
measure: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12
timeFrame: Week 12
measure: Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32
timeFrame: Week 32
measure: Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28
timeFrame: Week 28
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
citation: Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M; CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007 Feb 8;356(6):580-92. doi: 10.1056/NEJMoa062382.