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PEARL: Ustekinumab in Korean and Taiwanese Psoriasis Patients
NCT00747344Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2008
- Primary completion
- Sep 2009
- Countries
- 2
- Sponsor
- Janssen Pharmaceutical
- Modality
- Monoclonal Antibodies
- Drugs
- ustekinumab
- Conditions
- plaque psoriasis
01
Overview
Phase 3, randomised, double-blind trial in plaque psoriasis comparing Ustekinumab Group with Placebo Group (2 arms). Primary endpoint: Proportion of Patients Achieving at Least 75% Improvement in PASI at 12 weeks. Started Dec 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ustekinumab Group
Ustekinumab 45mg at Weeks 0, 4, 16 (Placebo at Week 12)
Placebo Group
Placebo at Weeks 0, 4; Ustekinumab 45mg at Weeks 12, 16
03
Endpoints
Primary
Proportion of Patients Achieving at Least 75% Improvement in PASI
Secondary
Proportion of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1)
Change in Dermatology Life Quality Index (DLQI) From Baseline
04
Results
Primary endpoints met
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