Deucravacitinib for Psoriatic Arthritis

Recruiting at 475 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Biologics

Disqualifiers: Nonplaque psoriasis, Lupus, Rheumatoid arthritis, Fibromyalgia, 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

670 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called deucravacitinib to see if it can help people with psoriatic arthritis who haven't tried advanced treatments. The medication works by reducing joint swelling and pain by blocking inflammation. Deucravacitinib is a new oral drug that has shown good results in previous studies for psoriasis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the drug deucravacitinib for psoriatic arthritis?

In a phase II clinical trial, deucravacitinib showed sustained effectiveness in treating psoriatic arthritis, particularly in reducing symptoms like arthritis, enthesitis (inflammation where tendons or ligaments attach to bone), and dactylitis (swelling of fingers or toes). It was well tolerated and had a favorable safety profile, making it a promising option for managing psoriatic arthritis. ^{1 2 3 4 5}

Is Deucravacitinib safe for humans?

Deucravacitinib has been tested in humans for conditions like psoriasis and psoriatic arthritis, showing a favorable safety profile. Common side effects include upper respiratory infections, mouth ulcers, and acne, but no serious adverse events were reported in early studies. ^{1 2 5 6 7}

How is the drug deucravacitinib unique for treating psoriatic arthritis?

Deucravacitinib is unique because it is a first-in-class, oral drug that selectively inhibits tyrosine kinase 2 (TYK2), a protein involved in the immune response that contributes to psoriatic arthritis. This specific targeting may offer a new option for patients who do not respond well to existing treatments. ^{1 2 6 8 9}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with active psoriatic arthritis who haven't used biologic disease-modifying anti-rheumatic drugs. They should have at least 3 swollen and tender joints, a diagnosis of PsA for 3+ months, an active skin lesion or history of plaque psoriasis, and certain levels of inflammation markers in their blood.

Inclusion Criteria

I have finished a year-long treatment in a previous study phase.

I have been diagnosed with psoriatic arthritis for at least 3 months.

My X-rays show at least one erosion in my hand or foot joints due to PsA.

Exclusion Criteria

I have an autoimmune condition like lupus or multiple sclerosis.

I have or had joint inflammation not caused by PsA, like gout or rheumatoid arthritis.

I do not have plaque psoriasis currently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either deucravacitinib or placebo to evaluate efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension

The long term extension period will provide additional long-term efficacy and safety information

Treatment Details

Interventions

• Deucravacitinib
• Placebo

Trial Overview The study tests the effectiveness and safety of Deucravacitinib compared to a placebo in treating psoriatic arthritis. Participants will be randomly assigned to receive either the drug or placebo to assess long-term effects.

Participant Groups

Group I: Deucravacitinib Experimental Treatment 1 Intervention

Group II: 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

Findings from Research

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 (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, 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Deucravacitinib for the treatment of psoriatic arthritis: the evidence so far. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes. [2023]

4. 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]

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

First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]

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

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

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

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

8. 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]

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

Deucravacitinib: First Approval. [2022]