Phase 3
Completed N=158
An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis
Source: ClinicalTrials.gov NCT00723528 ↗Enrolled (actual)
158
Serious AEs
5.1%
Results posted
May 2014
Primary outcomePrimary: Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score — 6.5; 59.4; 67.7 Percentage of participants — p=<0.0001
Summary
The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score |
6.5; 59.4; 67.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 |
-0.3; -8.0; -7.4 | <0.0001 sig |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score |
10.83; 8.29; 6.60; 4.94 | — |
| SECONDARY Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score |
70.78; 63.07; 78.86; 82.36 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score |
80; 71.4; 91.7; 89.3; 60; 50 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 |
-6.4; -6.2; -7.5; -7.6; -6.5; -6.5 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 |
-.88; -1.03; 7.76; 5.14; 1.16; 2.84 | — |
| SECONDARY Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 |
0.1; 0.1; -8.6; -12.0; -10.0; -8.1 | — |
| SECONDARY Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score |
11.1; 6.3; 7.7; 10.0; 34.9; 34.5 | — |
| SECONDARY Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 |
0.9; -0.1; 0; 0; -0.1; -0.1 | — |
| SECONDARY Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 |
0.5; 23.0; -38.5; -9.3; -8.0; NA | — |
| SECONDARY Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12 |
9.7; 57.8; 69.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 |
13.3; 21.4; 21.7; 28.6; 53.3; 71.4 | — |
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before registration
- Participants with plaque type psoriasis covering at least 10 percent of total body surface area at the time of informed consent and at registration
- Participants with a PASI score of greater than or equal to 12 at the time of informed consent and at registration
- Female participants of childbearing potential or males, whose partner can be pregnant, must agree that he/she will continuously take an appropriate contraceptive measure for 1 year from the day of informed consent to termination of the final investigational treatment; in the case of childbearing potential females, pregnancy test at screening must be negative
- Participants must agree not to receive Bacillus Calmette-Guérin (BCG) vaccination and live vaccine inoculation for 1 year after final treatment with the investigational product
Exclusion Criteria
- Participants with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis
- Participants with a medical history of tuberculosis infection or suspected tuberculosis infection
- Participants with present or past history of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection)
- Participants with a current serious infection (e.g., sepsis, hepatitis, pneumonia, or pyelonephritis) or those who experienced a serious infection within the 2 month period before registration and including participants who received intravenous administration of antibiotics or antiviral agents within the 2 month period before registration
- Participants with a current or past history of malignant tumors (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and uterine cervical squamous cell carcinoma, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)
Data sourced from ClinicalTrials.gov (NCT00723528). 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.