A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- DMB-3115
- Conditions
- Moderate to Severe Chronic Plaque Psoriasis
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 598
- Locations
- 2
- Primary Endpoint
- • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
DMB-3115
Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
Intervention: DMB-3115
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
Intervention: DMB-3115
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
Intervention: Stelara
Outcomes
Primary Outcomes
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
Time Frame: 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.