Moderate to Severe Chronic Plaque Psoriasis
Conditions
Brief summary
This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
Interventions
DRUGDMB-3115
45mg or 90mg dose subcutaneous administration
DRUGStelara
45mg or 90mg dose subcutaneous administration
Sponsors
Meiji Seika Pharma Co., Ltd.
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.
Exclusion criteria
* Patients with hypersensitivity to ustekinumab or any of the product excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Week 8 (For EMA) and 12 (For FDA) | Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DMB-3115 Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
DMB-3115: 45mg or 90mg dose subcutaneous administration | 299 |
| Stelara Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115
DMB-3115: 45mg or 90mg dose subcutaneous administration
Stelara: 45mg or 90mg dose subcutaneous administration | 299 |
| Total | 598 |
Baseline characteristics
| Characteristic | DMB-3115 | Total | Stelara |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 13.03 | 45.6 years STANDARD_DEVIATION 13.23 | 45.7 years STANDARD_DEVIATION 13.46 |
| Race/Ethnicity, Customized Ethnicity Ethnicity : Hispanic or Latino | 1 Participants | 6 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Ethnicity : Not Hispanic or Latino | 297 Participants | 591 Participants | 294 Participants |
| Race/Ethnicity, Customized Ethnicity Ethnicity : Unknown | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 295 Participants | 593 Participants | 298 Participants |
| Region of Enrollment Europe | 273 participants | 543 participants | 270 participants |
| Region of Enrollment Georgia | 3 participants | 5 participants | 2 participants |
| Region of Enrollment Ukraine | 13 participants | 29 participants | 16 participants |
| Region of Enrollment United States | 10 participants | 21 participants | 11 participants |
| Sex: Female, Male Female | 97 Participants | 184 Participants | 87 Participants |
| Sex: Female, Male Male | 202 Participants | 414 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 299 | 1 / 299 | 0 / 267 | 0 / 132 | 0 / 131 |
| other Total, other adverse events | 73 / 299 | 90 / 299 | 17 / 267 | 15 / 132 | 11 / 131 |
| serious Total, serious adverse events | 5 / 299 | 3 / 299 | 0 / 267 | 2 / 132 | 0 / 131 |
Outcome results
Primary
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction.
Time frame: Week 8 (For EMA) and 12 (For FDA)
Population: Per protocol set for EMA, Intention-to-Treat set for FDA
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DMB-3115 | • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Week 8 (for EMA) | 77.5 percent change in PASI score | Standard Error 2.595 |
| DMB-3115 | • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Week 12 (for FDA) | 87.59 percent change in PASI score | Standard Error 1.886 |
| Stelara | • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Week 8 (for EMA) | 77.85 percent change in PASI score | Standard Error 2.587 |
| Stelara | • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Week 12 (for FDA) | 87.89 percent change in PASI score | Standard Error 1.884 |