Deucravacitinib for Psoriasis

(POETYK PSO-LTE Trial)

Not currently recruiting at 462 trial locations

Overseen By Cheryl Hull, Site 0038

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Tuberculosis, 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: Long-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of Deucravacitinib for long-term use in individuals with moderate-to-severe psoriasis, a skin condition characterized by red, scaly patches. Researchers aim to determine if Deucravacitinib affects the body's response to certain vaccines, such as those for pneumonia and tetanus. The trial includes participants who have used Deucravacitinib for at least a year and completed an earlier related study. Ideal candidates are those with moderate-to-severe plaque psoriasis currently receiving Deucravacitinib treatment in the United States, Canada, or Poland. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 consistently safe for treating moderate to severe plaque psoriasis. In one study, patients used the drug for four years, and it was well-tolerated throughout. Another study also supported its long-term safety and effectiveness for these patients.

These studies suggest that side effects are manageable and that the treatment is generally safe for long-term use. Considering this evidence is important when deciding to join a clinical trial for deucravacitinib. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Deucravacitinib is unique because it works by selectively inhibiting the tyrosine kinase 2 (TYK2) enzyme, which plays a crucial role in the inflammatory pathways involved in psoriasis. Unlike standard treatments, which often include topical corticosteroids and systemic therapies like methotrexate or biologics targeting TNF-alpha, IL-17, or IL-23, deucravacitinib offers a novel mechanism of action. Researchers are excited about this treatment because it has the potential to offer effective relief with a different approach, possibly leading to fewer side effects and providing a new option for patients who may not respond well to existing therapies.

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

Research has shown that deucravacitinib holds promise for treating psoriasis. Studies found that more than 75% of patients experienced a significant reduction in symptoms after using it. This improvement persisted for at least five years, demonstrating its long-term effectiveness. Deucravacitinib has also proven safe, with no major safety issues reported over time. Overall, evidence supports its use as an effective treatment for moderate to severe plaque psoriasis. Participants in this trial will receive deucravacitinib to further evaluate its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people who have completed a prior Phase 3 study of BMS-986165 for moderate-to-severe psoriasis. Women participants should not be pregnant, breastfeeding, or lactating. Individuals with any condition that could interfere with the study or those showing active symptoms of tuberculosis are excluded.

Inclusion Criteria

Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis

I am not pregnant, lactating, or breastfeeding.

Exclusion Criteria

I do not have any signs or symptoms of tuberculosis.

Any disease or medical condition that the investigator feels would make the patient unsuitable for this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Deucravacitinib (BMS-986165) to assess long-term safety and efficacy

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib (BMS-986165)

Trial Overview The focus is on Deucravacitinib (BMS-986165), assessing its long-term safety and effectiveness in individuals who've previously taken part in a related Phase 3 trial for treating psoriasis.

How Is the Trial Designed?

Group I: Vaccine Cohort Experimental Treatment 2 Interventions

Group II: BMS-986165 Experimental Treatment 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

Published Research Related to This Trial

Deucravacitinib, an oral medication for moderate to severe plaque psoriasis, demonstrated higher PASI 75 response rates compared to apremilast and methotrexate across all time points in a network meta-analysis of 47 randomized controlled trials.

Long-term efficacy of deucravacitinib was comparable to first-generation biologics like adalimumab and ustekinumab, making it a viable oral treatment option for patients seeking effective psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. Armstrong, AW., Warren, RB., Zhong, Y., et al.[2023]

Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.

The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. Jing, S., Lin, Y., Dockens, R., et al.[2023]

Deucravacitinib is an oral small molecule that specifically inhibits TYK2, showing promising safety and efficacy for treating moderate to severe plaque psoriasis.

In phase III clinical trials, over 50% of patients taking deucravacitinib 6 mg daily achieved a significant reduction in psoriasis severity (≥75% improvement) at 16 weeks, compared to only 9-13% on placebo and 35-41% on another treatment, apremilast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. Vu, A., Maloney, V., Gordon, KB.[2022]

Deucravacitinib, an oral TYK2 inhibitor, demonstrated significant efficacy in treating moderate to severe plaque psoriasis, with 65.1% of patients achieving a PASI 75 response at week 16 across 6 clinical trials involving 2248 subjects.

The safety profile of deucravacitinib is favorable, with mild adverse events like nasopharyngitis being common, and serious adverse events occurring in only 1.35% to 9.5% of patients, making it a potentially less burdensome treatment option compared to injectable therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis. Truong, TM., Pathak, GN., Singal, A., et al.[2023]

Deucravacitinib, an oral tyrosine kinase 2 inhibitor, showed significant improvements in psoriasis symptoms and quality of life as early as Week 4 in a 12-week Phase 2 trial involving adults with moderate to severe plaque psoriasis.

Patients experienced better quality of life alongside clinical improvements, indicating that as psoriasis symptoms improved, so did their overall well-being, suggesting that deucravacitinib could be a promising new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Thaçi, D., Strober, B., Gordon, KB., et al.[2022]

In a phase 3 trial involving 66 Japanese patients with moderate to severe plaque psoriasis, deucravacitinib showed significantly higher efficacy compared to placebo and apremilast, with 78.1% of patients achieving a ≥75% reduction in PASI score at Week 16.

The safety profile of deucravacitinib was comparable to that of placebo and apremilast, with similar incidence rates of adverse events, and the most common side effect being nasopharyngitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. Imafuku, S., Tada, Y., Hippeli, L., et al.[2023]

Deucravacitinib is an oral small molecule that selectively inhibits Tyrosine Kinase 2, showing promise as a new treatment option for managing moderate-to-severe psoriasis, especially for patients who cannot use conventional systemic treatments due to contraindications or adverse events.

The review highlights the need for new therapies like deucravacitinib to improve treatment personalization and maintain long-term effectiveness in psoriasis management, addressing the limitations of existing biological drugs and small molecules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Deucravacitinib for the Management of Psoriasis: A Review of the Current Literature. Potestio, L., Ruggiero, A., Fabbrocini, G., et al.[2023]

Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.

It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. Hoy, SM.[2022]

Citations

1. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Two-Late-Breaking-Presentations-Demonstrating-Sotyktu-deucravacitinib-Efficacy-in-Psoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/default.aspx

Corporate news details New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; ...

2. 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.

3. 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40836369/

A Review of Phase III and Long-Term Data for ... Long-term data suggest sustained efficacy through 3 years of continuous treatment. Deucravacitinib was well tolerated, with a safety profile ...

5. 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), ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07116967

Long-Term Safety Study of Deucravacitinib Versus ... A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1806382

Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in ... At week 12, the percentage of patients with a 75% or greater reduction in the PASI score was 7% (3 of 45 patients) with placebo, 9% (4 of 44 ...