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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

Opportuniti Trial Summary

This trial will compare DMB-3115 to Stelara to see if it is more effective, has fewer side effects, and is more tolerable for people with moderate to severe plaque psoriasis.

Eligible Conditions
  • Plaque Psoriasis

Opportuniti Trial Eligibility Criteria

Inclusion Criteria

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

Opportuniti Trial 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
11%
Nasopharyngitis
6%
COVID-19
4%
Upper respiratory tract infection
4%
Hypertension
3%
Rhinitis
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stelara (Period 1)
Stelara (Period 2)
DMB-3115 (Period 2)
DMB-3115 (Period 1)
Switch to DMB-3115 (Period 2)

Opportuniti 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
121 Previous Clinical Trials
440,211 Total Patients Enrolled
Meiji Seika Pharma Co., Ltd.Industry Sponsor
13 Previous Clinical Trials
1,730 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
2021. "Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04785326.
~153 spots leftby Apr 2025
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