What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis include TNF-alpha inhibitors, IL-12/23 inhibitors, and methotrexate. TNF-alpha inhibitors, such as adalimumab and etanercept, can cause infections, injection site reactions, and increased risk of malignancies. IL-12/23 inhibitors like ustekinumab may lead to infections, headaches, and injection site reactions. Methotrexate, an oral or injectable treatment, can cause gastrointestinal distress, hepatotoxicity, hematologic toxicity, and pulmonary toxicity. Monitoring for liver and blood abnormalities is necessary during methotrexate treatment. Deucravacitinib, a selective TYK2 inhibitor, is being studied for its safety and efficacy, and its side effects are still being evaluated.

What prior FDA approvals exist?

The FDA has approved several biologic agents and kinase inhibitors for the treatment of Psoriatic Arthritis (PsA). These include TNF inhibitors such as adalimumab, etanercept, and infliximab, which have shown efficacy in reducing symptoms and improving quality of life. Additionally, IL-17 inhibitors like secukinumab and ixekizumab, and IL-12/23 inhibitor ustekinumab, have been approved for PsA treatment. These biologics target specific pathways involved in the inflammatory process of PsA. While Deucravacitinib, a selective TYK2 inhibitor, is still under study, it represents a novel approach similar to these existing treatments by targeting specific immune pathways to manage PsA.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Psoriatic Arthritis patients include Secukinumab and Ixekizumab, both of which are IL-17A monoclonal antibodies. Secukinumab has demonstrated significant improvement in joint and skin symptoms, physical function, and quality of life in clinical trials. Ixekizumab has also shown efficacy in treating moderate to severe plaque psoriasis and PsA. Additionally, Upadacitinib, a selective JAK1 inhibitor, has shown a rapid and favorable efficacy profile in rheumatoid arthritis and may be considered for PsA treatment.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Psoriatic Arthritis

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have completed the week 52 treatment for the optional open-label long-term extension period

Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening

Must not have

History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)

Active fibromyalgia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects of Deucravacitinib aren't listed here, similar medications can cause immune system changes leading to infections, liver issues, blood problems, potential risk of cancerous growths due to altered immunity response among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have active arthritis with at least 3 swollen and 3 tender joints.

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I have active psoriasis or a history of it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with active fibromyalgia.

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I do not have plaque psoriasis currently.

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I have taken approved or experimental drugs for PsA or PsO.

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I have an autoimmune condition like lupus or multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Upper respiratory tract infection

Cough

Pyrexia

Mouth ulceration

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: DeucravacitinibExperimental Treatment1 Intervention

Group II: ApremilastExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~160

Apremilast

2017

Completed Phase 4

~2300

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psoriatic Arthritis (PsA) treatments target specific pathways involved in the disease's inflammatory process. TNF inhibitors (e.g., adalimumab, infliximab) block TNF-alpha, a key cytokine in inflammation. IL-17 inhibitors (e.g., secukinumab, ixekizumab) and IL-12/23 inhibitors (e.g., ustekinumab) target cytokines in the IL-23/Th17 pathway, reducing inflammation and joint damage. Deucravacitinib, a selective TYK2 inhibitor, targets the TYK2 enzyme, which is crucial for signaling in cytokines like IL-23 and IL-12, thereby reducing inflammation. These targeted treatments help manage PsA more effectively by addressing the specific mechanisms driving the disease.

[Targeted treatment in spondyloarthritis].