598 Participants Needed

Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

(Opportuniti Trial)

Recruiting at 1 trial location
JS
Overseen ByJi-Su Song
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Dong-A ST Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications, so it's best to ask the trial organizers for more details.

What data supports the effectiveness of the drug DMB-3115, Stelara?

Research shows that Stelara, a component of DMB-3115, is effective in treating Crohn's Disease, with about 50% of patients experiencing clinical remission after one year. It is also used for conditions like plaque psoriasis and psoriatic arthritis, indicating its broad effectiveness in managing immune-related conditions.12345

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous DMB-3115 or Stelara for treatment of moderate to severe chronic plaque psoriasis

28 weeks
Regular visits for administration and monitoring

Re-randomization and Continued Treatment

Participants initially on Stelara are re-randomized to continue Stelara or switch to DMB-3115

Post-Week 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DMB-3115
  • Stelara
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dong-A ST Co., Ltd.

Lead Sponsor

Trials
127
Recruited
447,000+
Min-Young Kim profile image

Min-Young Kim

Dong-A ST Co., Ltd.

Chief Executive Officer

Bachelor of Business Administration, Seoul National University

Young-Sam Keum profile image

Young-Sam Keum

Dong-A ST Co., Ltd.

Chief Medical Officer since 2023

Pharm.D., Rutgers University

Meiji Seika Pharma Co., Ltd.

Industry Sponsor

Trials
14
Recruited
2,300+

Published Research Related to This Trial

In a study of 36 adults with Crohn's disease, 61% responded to ustekinumab treatment after one year, but no distinct gene expression signature was found to predict response, indicating that more research is needed to identify reliable biomarkers.
Among nonresponders, an increased inflammatory response was observed, with 68 genes linked to cytokine activity and chemokine receptor binding, suggesting that these pathways may play a role in treatment resistance.
Baseline peripheral blood mononuclear cell (PBMC) transcriptomics before ustekinumab treatment is linked with Crohn Disease clinical response at 1 year.Granot, M., Braun, T., Efroni, G., et al.[2023]
This case report highlights a rare instance of severe Staphylococcus aureus infection in a 64-year-old woman who had recently received ustekinumab for psoriatic arthritis, suggesting that while ustekinumab is generally safe, clinicians should remain vigilant for potential severe infections in patients on biological therapies.
The report emphasizes the importance of ongoing monitoring for rare but serious infections in patients treated with biologicals like ustekinumab, as symptoms may be nonspecific and fever may not always be present, necessitating thorough investigation when inflammatory markers are elevated.
Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab.Joost, I., Steinfurt, J., Meyer, PT., et al.[2018]
Ustekinumab (STELARA) is effective for treating moderate-to-severe plaque psoriasis in pediatric patients aged 6 to 12, as shown by a phase III study that developed a pharmacokinetic model to predict its behavior in this age group.
The study successfully used data from adult patients to create a model that predicts clinical responses in children, indicating that ustekinumab's efficacy and safety profile can be extrapolated from adults to younger patients.
Extrapolating Pharmacodynamic Effects From Adults to Pediatrics: A Case Study of Ustekinumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis.Zhou, W., Hu, C., Zhu, Y., et al.[2021]

Citations

Baseline peripheral blood mononuclear cell (PBMC) transcriptomics before ustekinumab treatment is linked with Crohn Disease clinical response at 1 year. [2023]
Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab. [2018]
Extrapolating Pharmacodynamic Effects From Adults to Pediatrics: A Case Study of Ustekinumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis. [2021]
[Ustekinumab-induced eosinophilic pneumonia during the course of ustekinumab therapy for plaque psoriasis]. [2015]
Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. [2022]
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