Deucravacitinib for Psoriasis

Overseen By Raymond Cho, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Systemic immunosuppressives

Disqualifiers: Pregnancy, Severe immunodeficiency, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called deucravacitinib for people with psoriasis. Researchers aim to observe how this medication affects immune cells in the skin and blood before and after treatment. The trial targets individuals with moderate to severe psoriasis, covering more than 10% of the body and causing significant discomfort. Participants should not have recently taken certain immune system medications or have serious infections. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you have not taken systemic immunosuppressives (medications that suppress the immune system) in the last 12 weeks. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What is the safety track record for deucravacitinib?

Research shows that deucravacitinib is generally safe for people. Studies have consistently confirmed its safety over several years. For example, one study tracked patients for up to five years and found no new safety issues. More than 5,000 patient-years of data support these findings, indicating that many people have used it for a long time without major problems.

Additionally, other research over four years also confirms that deucravacitinib is safe for those with moderate to severe plaque psoriasis. This means the treatment is well-tolerated and rarely causes serious side effects.

Overall, studies so far provide strong evidence that deucravacitinib is safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about deucravacitinib for psoriasis because it offers a novel approach compared to traditional treatments like biologics and topical therapies. Unlike these options, deucravacitinib is a selective tyrosine kinase 2 (TYK2) inhibitor, which means it targets a specific pathway involved in the inflammation process of psoriasis. This specificity may lead to fewer side effects and potentially more effective management of the condition. Additionally, as an oral medication, it provides a convenient alternative for patients who might prefer not to use injectable or topical treatments.

What is the effectiveness track record for deucravacitinib in treating psoriasis?

Research has shown that deucravacitinib effectively treats psoriasis. One study found that by Week 16, 53% of participants taking Sotyktu (deucravacitinib) had skin that was 75% clearer, compared to only 9% of those on a placebo. Over five years, patients who continued the treatment maintained significant skin improvement, with 67.3% achieving clear skin. The treatment also proved safe and effective over four years. These results suggest that deucravacitinib is a reliable option for managing moderate to severe plaque psoriasis. ^{1 2 3 4 6}

Who Is on the Research Team?

Raymond Cho, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults with moderate to severe psoriasis (covering at least 10% of their body, with a severity score of 12 or more) can join this trial. They shouldn't have tuberculosis, serious infections, be pregnant or breastfeeding, have used immunosuppressives recently, suffer from severe immune system problems, or any condition that might risk safety or data quality.

Inclusion Criteria

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

Exclusion Criteria

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

I have an active cancer that is affecting my whole body.

I do not have tuberculosis or any serious infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with deucravacitinib for 6 months

6 months

Biopsy and blood samples collected before and during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• deucravacitinib

Trial Overview The trial is testing deucravacitinib's effect on skin and blood immune cells in psoriasis patients. It involves taking the TYK2 inhibitor deucravacitinib and monitoring how it changes the function of these cells before and after treatment starts.

How Is the Trial Designed?

Group I: deucravacitinib treatment Experimental Treatment 1 Intervention

treatment with deucravacitinib for 6 months

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?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Bristol-Myers Squibb

Industry 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 (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 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]

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, 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]

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 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]

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. 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 ...

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 ...