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Monoclonal Antibodies
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (Opportuniti Trial)
Phase 3
Waitlist Available
Research Sponsored by Dong-A ST Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 (for ema) and 12 (for fda)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new drug, DMB-3115, to see if it works as well as Stelara for people with moderate to severe chronic plaque psoriasis. Both drugs are injected under the skin and aim to reduce symptoms by affecting the immune system. Stelara is already used to treat this condition.
Eligible Conditions
- Psoriasis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8 (for ema) and 12 (for fda)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 (for ema) and 12 (for fda)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
Side effects data
From 2022 Phase 3 trial • 598 Patients • NCT047853268%
Nasopharyngitis
5%
COVID-19
4%
Rhinitis
4%
Hypertension
3%
Headache
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
DMB-3115 (Period 1)
Stelara (Period 1)
DMB-3115 (Period 2)
Stelara (Period 2)
Switch to DMB-3115 (Period 2)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DMB-3115Experimental Treatment1 Intervention
Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
Group II: StelaraActive Control2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DMB-3115
2021
Completed Phase 3
~600
Find a Location
Who is running the clinical trial?
Dong-A ST Co., Ltd.Lead Sponsor
126 Previous Clinical Trials
446,509 Total Patients Enrolled
Meiji Seika Pharma Co., Ltd.Industry Sponsor
13 Previous Clinical Trials
1,744 Total Patients Enrolled