Deucravacitinib for Plaque Psoriasis

Recruiting at 131 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Other psoriasis, Recent infection, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

153 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of the medication deucravacitinib (also known as Sotyktu or BMS-986165) for children with moderate to severe plaque psoriasis, a skin condition that causes itchy, scaly patches. It tests two different doses to determine which is more effective. Eligible participants must have had plaque psoriasis for at least six months and be suitable for treatments like light therapy or medication. Researchers will observe participants over five years to assess the treatment's long-term effects. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising treatment.

Will I have to stop taking my current medications?

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

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

Research has shown that deucravacitinib is safe for individuals with moderate to severe plaque psoriasis. In studies lasting up to four years, the treatment consistently proved safe, and most patients tolerated it well. Few experienced serious side effects, indicating deucravacitinib's general safety for long-term use. Additionally, one study found that many participants experienced significant skin improvement, with few negative reactions reported. This information supports the treatment's safety for those considering joining a trial. ^{1 2 3 4 5}

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

Most treatments for plaque psoriasis, like biologics and topical steroids, work by reducing inflammation or suppressing the immune system. But deucravacitinib is different; it targets a specific enzyme called TYK2 (tyrosine kinase 2), which plays a crucial role in the inflammatory process. This targeted approach potentially offers a more precise way to manage psoriasis with fewer side effects. Researchers are excited because deucravacitinib might provide significant relief for patients who haven't responded well to traditional therapies. Moreover, it is available in an oral form, which can be more convenient compared to injectable treatments.

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. One study found that 53% of participants taking deucravacitinib had skin 75% clearer by week 16, compared to only 9% of those on a placebo. Long-term results indicate that many patients maintain these improvements for several years. Specifically, after five years, 67.3% of patients still had significantly clearer skin. Additionally, deucravacitinib has consistently demonstrated safety in these studies. These findings suggest that deucravacitinib could be a promising option for managing plaque psoriasis. ^{1 2 5 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 kids and teens aged 4 to <18 with moderate to severe plaque psoriasis. They should be candidates for phototherapy or systemic therapy, have had psoriasis for at least 6 months, and not weigh less than the set limits. Those with other psoriasis types, recent infections, TB, or prior deucravacitinib use can't join.

Inclusion Criteria

My condition is moderate to severe.

I am between 12 and 18 years old for Cohort 1, or between 4 and 12 years old for Cohort 2.

I have finished 52 weeks of treatment in either Part A or B for a long-term study.

Exclusion Criteria

I have a type of psoriasis.

I have previously been treated with deucravacitinib.

I have had a recent infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A

Evaluation of drug levels of BMS-986165 to enable selection of 2 dose levels

Up to 6 weeks

Multiple visits (in-person)

Part B

Assessment of efficacy and safety of two dose levels in pediatric participants

Up to 16 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 66 weeks

Long-term extension (LTE)

Observation of long-term safety and tolerability of deucravacitinib

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The study tests Deucravacitinib's levels and effectiveness in young patients with plaque psoriasis. It has two parts: Part A finds the right doses; Part B checks how well these doses work. There's also a long-term part that looks at safety over five years.

How Is the Trial Designed?

Group I: Active treatment deucravacitinib standard dose Experimental Treatment 1 Intervention

Group II: Active treatment deucravacitinib half-standard dose Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

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

In a long-term study involving 674 patients, deucravacitinib showed significantly higher efficacy than adalimumab, with 67.2% of patients achieving a 75% reduction in psoriasis severity (PASI 75) at 112 weeks compared to 54.0% for adalimumab.

Deucravacitinib maintained stable response rates over two years, while adalimumab's effectiveness declined, suggesting that deucravacitinib may offer a more consistent long-term treatment option for moderate-to-severe plaque psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. Armstrong, AW., Park, SH., Patel, V., 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, 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]

In a study involving 100 healthy volunteers, deucravacitinib was found to be rapidly absorbed with a half-life of 8-15 hours, showing a favorable pharmacokinetic profile and no serious adverse events, indicating good safety.

Deucravacitinib effectively inhibited key immune pathways (IL-12/IL-23 and type I IFN) in a dose-dependent manner, suggesting its potential as a therapeutic option for various immune-mediated diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Catlett, IM., Aras, U., Hansen, L., 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]

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 (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.

The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. Gupta, AK., Wang, T., Vincent, K., 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]

Citations

1. 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), ...

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. sotyktu.com sotyktu.com/about-sotyktu/sotyktu-study-results

Moderate to Severe Plaque Psoriasis Study Results In one study, a majority of people taking SOTYKTU saw 75% CLEARER SKIN at Week 16 vs those taking placebo (53% vs 9%).

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

Safety and Efficacy of Deucravacitinib in Moderate to ... Overall, of the 513 patients continuously treated with deucravacitinib, most maintained clinical response rates through 3 years. Meaning The ...

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/poetyk-trial-sotyktu-moderate-severe-plaque-psoriasis

Five-Year POETYK PSO Trial Results Show Sustained ... 1. New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis. News ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39602111/

An Open-Label Extension of Randomized Clinical Trials Efficacy outcomes included 75% or greater or 90% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75/90) and static ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06979453

NCT06979453 | A Study to Evaluate the Efficacy, Safety ... A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis ( ...