A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

NCT ID: NCT00320216

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2005-03-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I (Placebo)

Patients in the placebo group will receive placebo at Weeks 0, 1, 2, 3, and 16. At week 20, all patients will receive a single dose of ustekinumab 90 mg.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in the placebo group will receive placebo medication.

Group II (Ustekinumab 45 mg)

Patients will receive single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).

Placebo

Intervention Type: DRUG

Patients in the placebo group will receive placebo medication.

Group III (Ustekinumab 90 mg)

Patients will receive 90 mg single dose ustekinumab at Week 0 and placebo at Weeks 1, 2, and 3. At Week 16 patients with PGA greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).

Placebo

Intervention Type: DRUG

Patients in the placebo group will receive placebo medication.

Group IV

Patients will receive 45 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16, patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 45 mg. At week 20, all patients will receive placebo.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).

Group V

Patients will receive 90 mg of ustekinumab at Weeks 0, 1, 2, and 3. At Week 16 patients with Physician's Global Assessment (PGA) greater than or equal to 3 will receive ustekinumab 90 mg. At week 20, all patients will receive placebo.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).

Interventions

Ustekinumab

Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).

Intervention Type: DRUG

Placebo

Patients in the placebo group will receive placebo medication.

Intervention Type: DRUG

Other Intervention Names

CNTO 1275

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

References

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.

Reference Type: DERIVED

PMID: 30739254 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17287478 (View on PubMed)

Other Identifiers

C0379T04

Identifier Type: OTHER

Identifier Source: secondary_id

CR005416

Identifier Type: -

Identifier Source: org_study_id

NCT00322998

Identifier Type: -

Identifier Source: nct_alias