DMB-3115 + Stelara for Psoriasis

(Opportuniti Trial)

No longer recruiting at 1 trial location

Overseen By Ji-Su Song

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Dong-A ST Co., Ltd.

Disqualifiers: Hypersensitivity to ustekinumab, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, DMB-3115, against an existing one, Stelara (a biologic therapy), for individuals with moderate to severe chronic plaque psoriasis, a skin condition that causes red, scaly patches. The goal is to determine if DMB-3115 is as safe and effective as Stelara. Participants will either continue with DMB-3115 or start with Stelara and may switch to DMB-3115 later in the study. This trial suits those who have had plaque psoriasis for at least six months and wish to explore new treatment options. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially new treatment option.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that DMB-3115 has a safety profile similar to Stelara in patients with moderate to severe plaque psoriasis. This means the side effects of DMB-3115 resemble those of Stelara, an approved psoriasis treatment. DMB-3115 is considered bioequivalent to Stelara, indicating it works in the body similarly. Overall, the treatment has been well-tolerated, with no unexpected side effects reported in the research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Unlike other treatments for plaque psoriasis that often rely on intravenous delivery, DMB-3115 is unique because it's administered subcutaneously, meaning it's injected just under the skin, which may offer more convenience. Researchers are excited about DMB-3115 as it aims to match or even surpass the efficacy and safety of Stelara, a well-known psoriasis treatment, while possibly offering improved patient comfort and adherence. This new approach could provide a more user-friendly option for those managing moderate to severe chronic plaque psoriasis.

What evidence suggests that this trial's treatments could be effective for moderate to severe chronic plaque psoriasis?

In this trial, participants will receive either DMB-3115 or Stelara. A previous study found DMB-3115 to be as effective and safe as ustekinumab, the main ingredient in Stelara. This indicates that DMB-3115 works as well as Stelara for treating moderate to severe plaque psoriasis. Research has shown that DMB-3115 produces similar results in how the body processes the drug and its safety profile. Stelara, the comparator in this trial, is already known to effectively treat plaque psoriasis. These findings suggest that DMB-3115 is likely a good treatment option, closely matching Stelara's results. ^{2 6 7 8 9}

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?

Group I: DMB-3115 Experimental Treatment 1 Intervention

Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment

Group II: Stelara Active Control 2 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

Who Is Running the Clinical Trial?

Dong-A ST Co., Ltd.

Lead Sponsor

Trials

127

Recruited

447,000+

Min-Young Kim

Dong-A ST Co., Ltd.

Chief Executive Officer

Bachelor of Business Administration, Seoul National University

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab. Joost, I., Steinfurt, J., Meyer, PT., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 6,610 patients with active rheumatoid arthritis, 25% achieved clinical remission while nearly 50% reached minimal disease activity (MDA) after 12 weeks of adalimumab treatment.

The study identified several predictors for achieving remission and MDA, including being male, younger age, and lower baseline disease activity, highlighting factors that may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. Burmester, GR., Ferraccioli, G., Flipo, RM., et al.[2022]

A 71-year-old male patient developed eosinophilic pneumonia after being treated with ustekinumab for severe psoriasis, highlighting a potential adverse effect of this medication.

After discontinuing ustekinumab and starting corticosteroid treatment, the patient's symptoms resolved, indicating that eosinophilic pneumonia can improve with treatment withdrawal and corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ustekinumab-induced eosinophilic pneumonia during the course of ustekinumab therapy for plaque psoriasis]. Amy de la Bretèque, M., Appere-De Vecchi, C., Zeboulon, C., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666328725001130

A Randomized, Double-Blind, Phase 3 Study to Compare ... Conclusions. DMB-3115 showed a similar clinical efficacy and safety profile to ustekinumab in patients with moderate-to-severe plaque psoriasis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04785326

Study Details | NCT04785326 | Efficacy, Safety, and ... This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12394248/

Pharmacokinetic Bioequivalence, Safety, and Immunogenicity ... In this study, DMB-3115 showed similar results in terms of pharmacokinetic and safety. In addition, DMB-3115 is the unique biosimilar to assess the partial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04785326?id=%22NCT00267969%22OR%22NCT00307437%22OR%22NCT00320216%22OR%22NCT00454584%22OR%22NCT00723528%22OR%22NCT00747344%22OR%22NCT01008995%22OR%22NCT01059773%22OR%22NCT01090427%22OR%22NCT01276847%22OR%22NCT01511315%22OR%22NCT01550744%22OR%22NCT01558310%22OR%22NCT01708603%22OR%22NCT01708629%22OR%22NCT01999868%22OR%22NCT02054481%22OR%22NCT02074982%22OR%22NCT02144857%22OR%22NCT02203032%22OR%22NCT02561806%22OR%22NCT02684357%22OR%22NCT02684370%22OR%22NCT02693470%22OR%22NCT02698475%22OR%22NCT02763969%22OR%22NCT02786732%22OR%22NCT02826603%22OR%22NCT04305327%22OR%22NCT04371185%22OR%22NCT04435600%22OR%22NCT04595409%22OR%22NCT04607980%22OR%22NCT04673786%22OR%22NCT04728360%22OR%22NCT04744363%22OR%22NCT04761627%22OR%22NCT04785326%22OR%22NCT04930042%22OR%22NCT04967508%22&rank=3&tab=results

Study Results | Efficacy, Safety, and Immunogenicity of ... Outcome Measures. 1. • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara. Type: Primary | Time Frame: Week 8 (For EMA) and 12 (For FDA). Adverse ...

5. springermedicine.com springermedicine.com/ustekinumab/psoriatic-arthritis/pharmacokinetic-bioequivalence-safety-and-immunogenicity-of-dmb-/51285176

Ustekinumab | Pharmacokinetic Bioequivalence, Safety, and ... The aim of this study was to investigate the pharmacokinetic bioequivalence between DMB-3115 and ustekinumab (EU-Stelara or US-Stelara) as well as the safety ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40720058/

and US-Stelara in Healthy Adult Participants: A ... Conclusion: DMB-3115 was bioequivalent to both reference ustekinumab in terms of pharmacokinetic profile and showed similar safety and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04785326

Study Details | NCT04785326 | Efficacy, Safety, and ... This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara

8. prnewswire.com prnewswire.com/news-releases/accord-biopharma-inc-announces-us-fda-acceptance-of-biologics-license-application-for-proposed-stelara-biosimilar-dmb-3115-302025983.html

Accord BioPharma, Inc. Announces U.S. FDA Acceptance ... DMB-3115 is a proposed biosimilar to STELARA®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis.

9. link.springer.com link.springer.com/article/10.1007/s12325-025-03290-9

and US-Stelara in Healthy Adult Participants: A ... Conclusion. DMB-3115 was bioequivalent to both reference ustekinumab in terms of pharmacokinetic profile and showed similar safety and ...