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

Trial Summary

What is the purpose of this trial?

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the Tyrosine kinase 2 (TYK2) blocker, deucravacitinib.

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.

Is deucravacitinib safe for humans?

Deucravacitinib has been shown to be generally safe in humans, with common side effects including upper respiratory infections, increased blood enzyme levels, herpes simplex infections, mouth ulcers, folliculitis (inflammation of hair follicles), and acne. Long-term use did not increase the rate of these side effects, suggesting a favorable safety profile compared to other similar treatments. ^{1 2 3 4 5}

How is the drug deucravacitinib unique for treating psoriasis?

Deucravacitinib is unique because it is an oral medication that specifically targets and inhibits TYK2, a protein involved in the immune response, using an allosteric mechanism (binding to a different site than the active site). This selectivity may offer a better safety profile compared to other treatments that affect a broader range of proteins. ^{1 2 5 6 7}

Research Team

Raymond Cho, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Deucravacitinib: First Approval. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Deucravacitinib in moderate-to-severe psoriasis. [2022]

6. England 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]