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

NCT00320216 | Completed Phase 2 Results

• 2 other identifiers: CR005416C0379T04
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Psoriasis; CNTO 1275; Ustekinumab; Stelara; Interleukin-12; IL-12; Interleukin-23; IL-23

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12

  Psoriasis Area and Severity Index (PASI)(0 \[ best\] -72 \[worst\]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.

  Week 12

Secondary Outcomes (3)

• Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12

  Week 12

• Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32

  Week 32

• Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28

  Week 28

Study Arms (5)

Group I (Placebo)

PLACEBO COMPARATOR

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.

Drug: Placebo

Group II (Ustekinumab 45 mg)

EXPERIMENTAL

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.

Drug: Ustekinumab; Drug: Placebo

Group III (Ustekinumab 90 mg)

EXPERIMENTAL

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.

Drug: Ustekinumab; Drug: Placebo

Group IV

EXPERIMENTAL

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.

Drug: Ustekinumab

Group V

EXPERIMENTAL

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.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

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

Also known as: CNTO 1275

Group II (Ustekinumab 45 mg); Group III (Ustekinumab 90 mg); Group IV; Group V

Placebo DRUG

Patients in the placebo group will receive placebo medication.

Group I (Placebo); Group II (Ustekinumab 45 mg); Group III (Ustekinumab 90 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (2)

• 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.

  PMID: 30739254 DERIVED

• 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.

  PMID: 17287478 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Centocor Research & Development, Inc.

1-800-457-6399

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: November 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: March 1, 2005
• Last Updated: April 20, 2015
• Results First Posted: December 19, 2012

Record last verified: 2015-03