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Trial record 1 of 1 for:    DMB-3115
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Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (Opportuniti)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04785326
Recruitment Status : Active, not recruiting
First Posted : March 5, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
Meiji Seika Pharma Co., Ltd.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Plaque Psoriasis Drug: DMB-3115 Drug: Stelara Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: DMB-3115
Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
 Drug: DMB-3115
45mg or 90mg dose subcutaneous administration
Active Comparator: 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
 Drug: DMB-3115
45mg or 90mg dose subcutaneous administration

Drug: Stelara
45mg or 90mg dose subcutaneous administration


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785326


Locations
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United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73071
United States, Utah
Jordan Valley Dermatology Center
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Meiji Seika Pharma Co., Ltd.
More Information
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT04785326    
Other Study ID Numbers: DMB-3115-2
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents