drugset
drugset / Trial / NCT04785326

Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT04785326 ↗

Phase 3 Completed 598 enrolled Dong-A ST Co., Ltd. Meiji Seika Pharma Co., Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2021-04-28
Primary completion
2022-02-10
Completion
2022-11-16

Outcome

Met primary endpoint

release “동아에스티(대표이사 사장 김민영)는 스텔라라(우스테키누맙, Ustekinumab) 바이오시밀러 ‘DMB-3115’의 글로벌 임상 3상에서 오리지널 의약품 대비 치료적 동등성과 안전성을 확인했다고 16일 밝혔다.” donga-st.com ↗

release “일차 평가 변수인 건선 면적 및 중증도 지수(Psoriasis Area and Severity Index, PASI)의 베이스라인 대비 백분율 변화(Percent change)에 대한 8주와 12주의 평가 결과에서 스텔라라와 치료적 동등성을 입증했다.” donga-st.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DMB-3115 Unknown 45 mg Subcutaneous
Subject DMB-3115 Unknown 90 mg Subcutaneous
Comparator Ustekinumab Monoclonal antibody 45 mg Subcutaneous
Comparator Ustekinumab Monoclonal antibody 90 mg Subcutaneous

Indications

psoriasis