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

NCT ID: NCT04785326

Last Updated: 2024-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2022-11-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Chronic Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DMB-3115

Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment

Group Type EXPERIMENTAL

DMB-3115

Intervention Type DRUG

45mg or 90mg dose subcutaneous administration

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

Group Type ACTIVE_COMPARATOR

DMB-3115

Intervention Type DRUG

45mg or 90mg dose subcutaneous administration

Stelara

Intervention Type DRUG

45mg or 90mg dose subcutaneous administration

Interventions

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DMB-3115

45mg or 90mg dose subcutaneous administration

Intervention Type DRUG

Stelara

45mg or 90mg dose subcutaneous administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meiji Seika Pharma Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Sooner Research

Norman, Oklahoma, United States

Site Status

Jordan Valley Dermatology Center

West Jordan, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

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DMB-3115-2

Identifier Type: -

Identifier Source: org_study_id

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