Psoriasis
Conditions
Keywords
psoriasis, asian patients, Chinese, ustekinumab, CNTO 1275, Stelara
Brief 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.
Detailed description
In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12
Interventions
DRUGplacebo
Subcutaneous injection at Week 0 and 4
DRUGustekinumab
45 mg subcutaneous injection at Week 12 and 16
Sponsors
Centocor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. | Baseline (Week 0) to Week 12 | Scores could range from 0 (mild) to 72 (severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | Week 12 | — |
| The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. | Baseline (Week 0) to Week 12 | Scores could range from 0 to 30. A lower DLQI score represents better quality of life. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo (CP) Controlled period (Week 0-12) - Placebo Group | 162 |
| Ustekinumab 45 mg (CP) Controlled period (Week 0-12) - Ustekinumab 45 mg Group | 160 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| After Controlled Period | Adverse Event | 0 | 0 | 1 | 1 |
| After Controlled Period | Other | 0 | 0 | 1 | 0 |
| Controlled Period | Adverse Event | 1 | 2 | 0 | 0 |
| Controlled Period | Other | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo (CP) | Ustekinumab 45 mg (CP) | Total |
|---|---|---|---|
| Age Continuous | 39.2 years STANDARD_DEVIATION 12.21 | 40.1 years STANDARD_DEVIATION 12.36 | 39.7 years STANDARD_DEVIATION 12.28 |
| Region of Enrollment China | 162 participants | 160 participants | 322 participants |
| Sex: Female, Male Female | 39 Participants | 35 Participants | 74 Participants |
| Sex: Female, Male Male | 123 Participants | 125 Participants | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 161 | 28 / 160 | 27 / 158 | 14 / 159 |
| serious Total, serious adverse events | 1 / 161 | 1 / 160 | 2 / 158 | 1 / 159 |
Outcome results
Primary
The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.
Scores could range from 0 (mild) to 72 (severe).
Time frame: Baseline (Week 0) to Week 12
Population: All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (CP) | The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. | 18 Participants |
| Ustekinumab 45 mg (CP) | The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. | 132 Participants |
Comparison: Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \[\<=65 kg vs \> 65 kg). The power was \>99% for both sample size assumptions.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.
Scores could range from 0 to 30. A lower DLQI score represents better quality of life.
Time frame: Baseline (Week 0) to Week 12
Population: Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (CP) | The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. | -1.9 Score | Standard Deviation 6.63 |
| Ustekinumab 45 mg (CP) | The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. | -9.3 Score | Standard Deviation 7.18 |
Comparison: Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.p-value: <0.001ANOVA
Secondary
The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Time frame: Week 12
Population: All participants were included and analyzed according to their randomized treatment group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (CP) | The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 24 Participants |
| Ustekinumab 45 mg (CP) | The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 | 126 Participants |
Comparison: Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.p-value: <0.001Cochran-Mantel-Haenszel