Phase 3
Completed N=322
A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis
Source: ClinicalTrials.gov NCT01008995 ↗Enrolled (actual)
322
Serious AEs
0.8%
Results posted
Sep 2012
Primary outcomePrimary: The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. — 18; 132 Participants — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. |
18; 132 | <0.001 sig |
| SECONDARY The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 |
24; 126 | <0.001 sig |
| SECONDARY The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. |
-1.9; -9.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Must be of Chinese ancestry
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start
- Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of study start
- Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start
- Must be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment)
Exclusion Criteria
- Currently have nonplaque forms of psoriasis
- Have current drug-induced psoriasis
- Have used any investigational drug within the previous 4 weeks
- Have used any biologic within the previous 3 months
- Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis
Data sourced from ClinicalTrials.gov (NCT01008995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.