Phase 3
Completed N=1,230
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Psoriasis
Source: ClinicalTrials.gov NCT00307437 ↗Enrolled (actual)
1,230
Serious AEs
10.5%
Results posted
Nov 2012
Primary outcomePrimary: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 — 15; 273; 311 Participants — p=<0.001
Summary
The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 |
15; 273; 311 | <0.001 sig |
| SECONDARY Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12 |
18; 277; 300 | <0.001 sig |
| SECONDARY Change in Dermatology Life Quality Index (DLQI) at Week 12 |
-0.5; -8.0; -9.0 | <0.001 sig |
| SECONDARY Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52 |
0; 1; 3; 1; 2; 1 | 0.468 |
Eligibility Criteria
Inclusion Criteria
- Plaque-type psoriasis diagnosed >= 6 months prior
- Plaque-type psoriasis covering at least 10% of total body surface areas
- Psoriasis area-and-severity index score of >=12 at screening and baseline
- 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 throughout the trials and for 12 months following the last injection of study agent
- Have no history of latent or active tuberculosis (TB)
Exclusion Criteria
- 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 used any therapeutic agent targeted at reducing IL-12 or IL-23
- Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous 12 months prior to screening
- 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 prior to screening
- Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
- Patients known to be infected with human immunodeficiency virus (HIV), 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
- Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
- Patients participating in another trial using an investigational agent or procedure
- Systemic immunosuppressants within 4 weeks of the first administration of study agent
Data sourced from ClinicalTrials.gov (NCT00307437). 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.