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

Phase 3

Completed

• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Interventions: Drug: DMB-3115; Drug: Stelara

• Registration Number: NCT04785326
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Study Start: 2021-04-28
• Primary Completion: 2022-02-10
• Study Completion: 2022-11-16
• Results First Submitted: 2023-11-08
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Results First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

Inclusion Criteria

• Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

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Exclusion Criteria

• Patients with hypersensitivity to ustekinumab or any of the product excipients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara	Week 8 (For EMA) and 12 (For FDA)	Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72.; The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe.; The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms.; If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction.

Trial Locations

Locations (2)

Central Sooner Research; 🇺🇸 Norman, Oklahoma, United States

Jordan Valley Dermatology Center; 🇺🇸 West Jordan, Utah, United States