Back to resultsEfficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (Opportuniti)
Primary Purpose
Moderate to Severe Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DMB-3115
Stelara
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Chronic Plaque Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Central Sooner Research
- Jordan Valley Dermatology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DMB-3115
Stelara
Arm Description
Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
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
Outcomes
Primary Outcome Measures
• To evaluate efficacy of DMB-3115 in comparison with Stelara
Percent change in the Psoriasis Area and Severity Index (PASI) score
Secondary Outcome Measures
Full Information
NCT ID
NCT04785326
First Posted
March 3, 2021
Last Updated
November 17, 2022
Sponsor
Dong-A ST Co., Ltd.
Collaborators
Meiji Seika Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04785326
Brief Title
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
Collaborators
Meiji Seika Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Chronic Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
605 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DMB-3115
Arm Type
Experimental
Arm Description
Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
Arm Title
Stelara
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
DMB-3115
Intervention Description
45mg or 90mg dose subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
Stelara
Intervention Description
45mg or 90mg dose subcutaneous administration
Primary Outcome Measure Information:
Title
• To evaluate efficacy of DMB-3115 in comparison with Stelara
Description
Percent change in the Psoriasis Area and Severity Index (PASI) score
Time Frame
Week 8 (For EMA) and 12 (For FDA)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Jordan Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
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