Deucravacitinib for Plaque Psoriasis

(POETYK-PsO-Ped Trial)

Recruiting at 111 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Non-plaque psoriasis, Serious infections, Cancer, others

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: 12 weeks

366 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new drug, Deucravacitinib, for treating moderate to severe plaque psoriasis in adolescents. Researchers aim to determine its safety, effectiveness, and how much of the drug remains in the body. Participants will receive either Deucravacitinib or a placebo (a pill with no active medicine) to compare results. Ideal candidates for this trial have had stable plaque psoriasis for at least six months and experience significant skin involvement that affects daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to bringing a potentially effective treatment to market.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that Deucravacitinib is likely to be safe for humans?

Research has shown that deucravacitinib is safe for treating moderate to severe plaque psoriasis. Studies tracking patients for up to five years found it remains safe over time, with no new or unexpected problems. Patients continued using deucravacitinib without major issues. No new side effects emerged, and overall, patients tolerated the treatment well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Deucravacitinib is unique because it targets a specific part of the immune system called TYK2, which is different from many current treatments for plaque psoriasis like biologics that often target TNF-α or IL-17. This new mechanism of action could mean fewer side effects and possibly better results for those who haven't had success with standard biologics or systemic treatments. Researchers are excited because deucravacitinib might offer a new option for patients with moderate to severe plaque psoriasis, potentially with more convenient oral dosing instead of injections.

What evidence suggests that Deucravacitinib might be an effective treatment for plaque psoriasis?

Research has shown that Deucravacitinib effectively treats moderate to severe plaque psoriasis. Studies have found significant improvement in psoriasis symptoms for many patients. For instance, one study found that 72.1% of patients experienced a 75% reduction in psoriasis severity after one year of treatment, with similar results over five years. Another study confirmed improvements in both skin condition and quality of life. These findings suggest that Deucravacitinib can be a promising option for managing plaque psoriasis symptoms. Participants in this trial will receive either Deucravacitinib or a placebo to further evaluate its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Adolescents with moderate to severe plaque psoriasis are eligible for this trial. Specific inclusion and exclusion criteria details were not provided, but typically these would cover health status, previous treatments, and other medical conditions that could affect the study's results.

Inclusion Criteria

My psoriasis is moderate to severe, covering more than 10% of my body.

My plaque psoriasis has been stable for at least 6 months.

I am not pregnant or breastfeeding and follow specific birth control measures.

Exclusion Criteria

I weigh at least 30 kg.

I only have plaque psoriasis with no other skin conditions.

I haven't had cancer or related diseases in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Deucravacitinib or placebo to evaluate efficacy, safety, and drug levels

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The trial is testing Deucravacitinib (BMS-986165), a medication intended for plaque psoriasis treatment in adolescents. Participants will either receive Deucravacitinib or a placebo to compare effectiveness and safety.

How Is the Trial Designed?

Group I: Administration of Deucravacitinib Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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

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

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12188513/

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.

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2827130

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 ...

3. news.bms.com news.bms.com/news/details/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

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), ...

4. psoriasis-hub.com psoriasis-hub.com/medical-information/deucravacitinib-in-moderate-to-severe-plaque-psoriasis-5-year-results-from-the-poetyk-pso-1-pso-2-and-lte-trials

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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/1346-8138.17665

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.gov pubmed.ncbi.nlm.nih.gov/40045918/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1l1vNBYu_ed6RIBx4yjiYJ-tnJX2DEnfLu2bT3RUcVLTGoG9AU&fc=None&ff=20250329043238&v=2.18.0.post9+e462414

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.

7. skin.dermsquared.com skin.dermsquared.com/skin/article/view/3309

Deucravacitinib in Moderate to Severe Plaque Psoriasis Conclusion: Deucravacitinib demonstrated a consistent safety profile through 5 years with no emergence of any new safety signals. Clinical ...