A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis

NCT00747344 | Completed Phase 3 Results DMC

• 1 other identifier: CR015313
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.

Conditions

Psoriasis

Keywords

Psoriasis; Psoriatic Arthritis; Ustekinumab; CNTO 1275

Outcome Measures

Primary Outcomes (1)

• The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12

  PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

  Week 12

Secondary Outcomes (2)

• The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

  Week 12

• The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12

  Baseline to Week 12

Study Arms (4)

Placebo - Controlled Period (CP)

PLACEBO COMPARATOR

Drug: Placebo - Controlled Period (CP)

Ustekinumab 45 mg - CP

EXPERIMENTAL

Drug: Ustekinumab 45 mg - CP

Placebo to ustekinumab 45 mg - after CP

EXPERIMENTAL

Drug: Placebo to ustekinumab 45 mg - after CP

Ustekinumab 45 mg - after CP

EXPERIMENTAL

Drug: Ustekinumab 45 mg - after CP

Interventions

Placebo - Controlled Period (CP) DRUG

Placebo, Weeks 0-12

Placebo - Controlled Period (CP)

Ustekinumab 45 mg - CP DRUG

Ustekinumab 45 mg, Weeks 0-12

Ustekinumab 45 mg - CP

Placebo to ustekinumab 45 mg - after CP DRUG

Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16

Placebo to ustekinumab 45 mg - after CP

Ustekinumab 45 mg - after CP DRUG

Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16

Ustekinumab 45 mg - after CP

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be of Taiwanese or Korean ancestry living in Taiwan or South Korea, respectively
• Have a diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study agent (patients with concurrent psoriatic arthritis may be enrolled)
• Have plaque-type psoriasis covering at least 10% of total body surface area at screening and at the time of first study agent administration
• PASI score of 12 or greater at the time of screening and at time of first study agent administration
• Candidate of phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment)
• Be able to adhere to the study visit schedule and other protocol requirements
• Capable of giving informed consent prior to any study related procedures.

You may not qualify if:

• Currently have a non-plaque form of psoriasis
• Have current drug-induced psoriasis
• Are pregnant or nursing or planning pregnancy (both men and women) while enrolled in the study
• Have used any investigational drug within the previous 4 weeks or 5 times the half life of the investigational agent, whichever is longer
• Have used any biologic within the previous 3 months or 5 times the half life of the biologic, whichever is longer
• Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short-term course of oral corticosteroids for asthma within the previous year
• Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis prior to screening.

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (5)

Unknown Facility

Anyang, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Changhua, Taiwan

Location

Unknown Facility

Kaohsiung County, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Janssen Research & Development, LLC

215-793-7646

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 29, 2013
• Results First Posted: October 5, 2012

Record last verified: 2013-03

Locations

KR (2); TW (3)