3040 Participants Needed

Deucravacitinib vs Ustekinumab for Plaque Psoriasis

Recruiting at 298 trial locations
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
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 explores two treatments, Deucravacitinib and Ustekinumab, to determine which is safer for individuals with moderate-to-severe plaque psoriasis, a skin condition causing red, scaly patches. The goal is to assess the long-term safety of these treatments. Individuals with psoriasis requiring special light therapy or medication, and who have cardiovascular risks such as smoking, diabetes, or high blood pressure, might be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of new treatments.

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

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial team or your doctor.

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

Previous studies have shown that deucravacitinib remains consistently safe over five years for people with moderate to severe plaque psoriasis. Although some patients experienced infections, no new safety issues emerged. In contrast, ustekinumab has been used for over 14 years and is considered safe compared to other psoriasis treatments. The FDA has approved it for moderate to severe plaque psoriasis. Both treatments have a long history, with no major safety surprises reported in recent years.12345

Why are researchers excited about this trial's treatments?

Deucravacitinib is unique because it targets the TYK2 enzyme, a part of the immune system pathway involved in inflammation, which is different from many current psoriasis treatments that often target other parts of the immune system. This new mechanism of action might offer better results for patients who don't respond well to traditional therapies like methotrexate or TNF inhibitors. Researchers are excited about its potential to provide a more targeted approach with possibly fewer side effects and improved effectiveness for managing plaque psoriasis.

What evidence suggests that this trial's treatments could be effective for psoriasis?

This trial will compare Deucravacitinib and Ustekinumab for treating plaque psoriasis. Research has shown that Deucravacitinib, which participants in this trial may receive, effectively treats moderate to severe plaque psoriasis. Studies found that about 72.1% of patients experienced significant improvement in their skin condition after one year, with this improvement remaining strong over five years. The treatment has demonstrated safety and effectiveness over time. Meanwhile, Ustekinumab, another treatment option in this trial, is well-known for treating psoriasis and has been widely used with good results. Both treatments aim to reduce the severity of psoriasis, but Deucravacitinib has shown promising long-term results in recent studies.13567

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for individuals with plaque psoriasis. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may be required to meet certain health standards.

Inclusion Criteria

I have severe plaque psoriasis and need systemic treatment or phototherapy.
I have a risk factor for heart disease, such as smoking or high blood pressure.

Exclusion Criteria

I haven't had any cancer or related diseases in the last 5 years, with some exceptions.
Other protocol defined inclusion/exclusion criteria apply.
I haven't had a heart attack, stroke, heart surgery, or blood clots in the last 3 months.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Deucravacitinib or Ustekinumab to evaluate long-term safety

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Deucravacitinib
  • Ustekinumab
Trial Overview The study is testing the long-term safety of two treatments for psoriasis: Deucravacitinib, which is an oral medication, versus Ustekinumab, an injectable biologic drug.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

Deucravacitinib in plaque psoriasis: Four‐year safety and ...Deucravacitinib demonstrated a consistent safety profile and durable efficacy through 4 years of treatment in patients with moderate to severe plaque psoriasis.
Safety and Efficacy of Deucravacitinib in Moderate to ...Efficacy outcomes included 75% or greater or 90% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and ...
New Five-Year Sotyktu (deucravacitinib) Data Show ...Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for PASI 75 (72.1%, Year 1; 67.3%, Year 5), ...
Deucravacitinib in moderate-to-severe plaque psoriasis: 5- ...Deucravacitinib demonstrated a consistent safety profile with no new safety signals and sustained clinical efficacy over 5 years. AE, adverse ...
Long‐term real‐world effectiveness of deucravacitinib in ...Previous phase III clinical trials have shown that deucravacitinib significantly improves skin rash and QoL in patients with psoriasis, with ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38226713/
Deucravacitinib in plaque psoriasis: 2-year safety and ...Deucravacitinib maintained efficacy and demonstrated consistent safety with no new safety signals observed through 2 years.
SOTYKTU® (deucravacitinib) Safety Profile | for HCPsInfections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security