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Completed

NCT Number: NCT04785326

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

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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Key information

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Central Sooner Research, Norman, Oklahoma, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DMB-3115

Drug

45mg or 90mg dose subcutaneous administration

Stelara

Drug

45mg or 90mg dose subcutaneous administration

Primary outcomes

  1. • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Collaborators

  • Meiji Seika Pharma Co., Ltd.

Registry information

Official study 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

Acronym: Opportuniti

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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