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Monoclonal Antibodies

DMB-3115 for 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 below

Timeline

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)

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

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 • NCT04785326

Nasopharyngitis

COVID-19

Rhinitis

Hypertension

Headache

Upper respiratory tract infection

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met