CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 598 enrolled
Drug / intervention
DMB-3115 +1 moredrug
Likely dose
DMB-3115 45mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04785326
NCT04785326Phase 3Completed
CompareCT.gov

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

Dong-A ST Co., Ltd.·interventional·Posted Mar 5, 2021·Updated Jan 18, 2024

In Brief

A Phase 3 clinical trial evaluating DMB-3115 and Stelara for Moderate to Severe Chronic Plaque Psoriasis. Completed, enrolled 598 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Chronic Plaque Psoriasis
CountriesUnited States
CollaboratorsMeiji Seika Pharma Co., Ltd.

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 5, 2021
Enrollment StartApr 28, 2021
Primary CompletionFeb 10, 2022
Study CompletionNov 16, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago

Interventions

DMB-3115drug

45mg or 90mg dose subcutaneous administration

Stelaradrug

45mg or 90mg dose subcutaneous administration