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

NCT04785326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2024-01-18

Study results available
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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

DRUG

DMB-3115

45mg or 90mg dose subcutaneous administration

DRUG

Stelara

45mg or 90mg dose subcutaneous administration

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    collaborator INDUSTRY

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2022-02-10
Completion
2022-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785326 on ClinicalTrials.gov