Phase 3
Completed N=766
A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT00267969 ↗Enrolled (actual)
766
Serious AEs
7.7%
Results posted
Aug 2012
Primary outcomePrimary: Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. — 8; 171; 170 Participants — p=<0.001
Summary
The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12. |
8; 171; 170 | <0.001 sig |
| SECONDARY Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 |
10; 151; 156 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12 |
0.0; -6.0; -7.0 | <0.001 sig |
| SECONDARY Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52 |
47; 67; 53; 77; 100; 144 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with plaque-type psoriasis diagnosed at least 6 months prior and covering at least 10% of total body surface areas
- Have psoriasis area-and-severity index score of >=12
- Patients who are considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
- Have no history of latent or active TB
Exclusion Criteria
- Currently have nonplaque forms of psoriasis or drug-induced psoriasis
- Have any therapeutic agent targeted at reducing IL-12 or IL-23
- Have had a BCG vaccination within the previous 12 months
- 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
- 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
- Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
Data sourced from ClinicalTrials.gov (NCT00267969). 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.