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Monoclonal Antibodies

DMB-3115 for 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

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
  • Plaque Psoriasis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 (for ema) and 12 (for fda)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 (for ema) and 12 (for fda) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara

Side effects data

From 2022 Phase 3 trial • 598 Patients • NCT04785326
8%
Nasopharyngitis
5%
COVID-19
4%
Hypertension
4%
Rhinitis
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)

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
122 Previous Clinical Trials
440,283 Total Patients Enrolled
Meiji Seika Pharma Co., Ltd.Industry Sponsor
13 Previous Clinical Trials
1,730 Total Patients Enrolled
~138 spots leftby Sep 2025
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