NCT04785326

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	DMB-3115	45mg or 90mg dose subcutaneous administration
DRUG	Stelara	45mg or 90mg dose subcutaneous administration

Timeline

• Start date: 2021-04-28
• Primary completion: 2022-02-10
• Completion: 2022-11-16
• First posted: 2021-03-05
• Last updated: 2024-01-18
• Results posted: 2024-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study