Deucravacitinib for Psoriatic Arthritis

Recruiting at 313 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, 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: 2

Duration: 16 weeks

729 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called deucravacitinib to help people with active Psoriatic Arthritis. It aims to reduce joint pain and swelling by blocking harmful signals in the body. The study includes people who haven't tried biologic treatments or need an alternative to TNFα inhibitors. Deucravacitinib is an emerging treatment option for Psoriatic Arthritis, showing promise in recent studies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have received biologic therapy for PsA or PsO, which might imply some restrictions on certain medications.

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 also well tolerated with a favorable safety profile. ^{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, increased blood enzyme levels, and mild skin issues, 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), which plays a key role in the immune response involved in psoriatic arthritis. This mechanism of action is different from other treatments, potentially offering a new option for patients who do not respond well to existing therapies. ^{1 2 6 8 9}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with active Psoriatic Arthritis (PsA) who are either new to biologic treatments or have tried TNFα inhibitors before. They must have had PsA for at least 3 months, with ≥3 swollen and tender joints, an active psoriasis skin lesion or a history of plaque psoriasis, and meet specific medical criteria. Those with non-plaque psoriasis types, other joint diseases like rheumatoid arthritis, fibromyalgia, or certain autoimmune conditions cannot join.

Inclusion Criteria

Your level of high sensitivity C-reactive protein (hsCRP) is 3 mg/L or higher at the screening.

I have active psoriasis or a history of it.

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

Exclusion Criteria

I have a history of or currently have an inflammatory joint disease other than Psoriatic Arthritis.

I have been diagnosed with active fibromyalgia.

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 deucravacitinib or placebo for the treatment of active Psoriatic Arthritis

16 weeks

Visits at Weeks 2, 4, 8, 12, 16

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 safety and efficacy information

Long-term

Treatment Details

Interventions

• Deucravacitinib
• Placebo

Trial Overview The study tests the safety and effectiveness of Deucravacitinib compared to a placebo in treating Psoriatic Arthritis. Participants will be randomly assigned to receive either Deucravacitinib or a placebo. The trial includes those new to biologic drugs as well as patients previously treated with TNFα inhibitors.

Participant Groups

Group I: Deucravacitinib Experimental Treatment 1 Intervention

Group II: Apremilast Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 2 Interventions

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. 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. 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]

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]