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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Chronic Plaque Psoriasis

Treatments: Drug: DMB-3115; Drug: Stelara

Study type: Interventional

Funder types: Industry

Identifiers

NCT04785326

DMB-3115-2

Details and patient eligibility

About

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.

Enrollment: 598 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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598 participants in 2 patient groups

DMB-3115

Experimental group

Description:

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

Treatment:

Drug: DMB-3115

Stelara

Active Comparator group

Description:

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

Treatment:

Drug: Stelara

Drug: DMB-3115