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

Moderate to Severe Chronic Plaque Psoriasis Clinical Trial

— Opportuniti  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785326
• Other study ID #: DMB-3115-2
• Status: Completed
• Phase: Phase 3
• Start date: April 28, 2021
• Est. completion date: November 16, 2022

Study information

• Verified date: January 2024
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: November 16, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DMB-3115
45mg or 90mg dose subcutaneous administration
• Stelara
45mg or 90mg dose subcutaneous administration

Locations

Country	Name	City	State
United States	Central Sooner Research	Norman	Oklahoma
United States	Jordan Valley Dermatology Center	West Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.	Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara	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.	Week 8 (For EMA) and 12 (For FDA)