What side effects are associated with this type of intervention?

Common treatments for moderate-to-severe psoriasis include biologics such as secukinumab, ixekizumab, brodalumab, guselkumab, and tildrakizumab. These treatments generally target specific components of the immune system to reduce inflammation and plaque formation. Known side effects of these biologics can include increased risk of infections, injection site reactions, and potential exacerbation of pre-existing conditions. For treatments similar to Deucravacitinib, which is a selective TYK2 inhibitor, side effects may include upper respiratory infections, headache, and gastrointestinal issues, although specific data on Deucravacitinib's side effects are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of psoriasis, focusing on targeting specific pathways in the immune system. Notable among these are TNF-alpha inhibitors such as etanercept, infliximab, and adalimumab, which have shown efficacy in reducing inflammation and the severity of psoriasis. Additionally, IL-12/23 inhibitors like ustekinumab and IL-17 inhibitors such as secukinumab and ixekizumab have been approved for their targeted action on specific interleukins involved in the pathogenesis of psoriasis. These treatments, like Deucravacitinib, aim to modulate the immune response to provide relief from the symptoms of psoriasis.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for psoriasis patients include Janus kinase (JAK) inhibitors like Tofacitinib and Upadacitinib, IL-23 inhibitors such as Risankizumab and Guselkumab, and IL-17 inhibitors like Secukinumab and Ixekizumab. These treatments have shown significant efficacy in clinical trials and are expected to be viable options in 2024.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Scalp Psoriasis

Phase 4

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

≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1

Evidence of plaque psoriasis in a non-scalp area

Must not have

Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 16

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing a medication called deucravacitinib to see if it can help people with moderate-to-severe scalp psoriasis. The medication works by blocking proteins that cause inflammation and immune responses, which are responsible for the red, itchy, and scaly patches on the scalp. The goal is to find out if this treatment is safe and effective.

Who is the study for?

This trial is for men and women with moderate-to-severe scalp psoriasis that's been stable for at least 6 months. Participants should be candidates for phototherapy or systemic therapy, have tried and not responded to one topical treatment, have a certain amount of scalp and body surface area affected, and can't have nonplaque forms of psoriasis.

What is being tested?

The study aims to see if Deucravacitinib is more effective and safe compared to a placebo in treating individuals with moderate-to-severe scalp psoriasis. It will involve giving some participants the actual drug while others receive an inactive substance (placebo) as a comparison.

What are the potential side effects?

While specific side effects are not listed here, common side effects from drugs like Deucravacitinib may include headache, nausea, diarrhea, high blood pressure, liver enzyme changes, respiratory infections among others.

Eligibility Criteria

Inclusion Criteria

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

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At least 3% of my body is affected by my condition.

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I have psoriasis plaques on parts of my body other than my scalp.

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I have tried at least one scalp psoriasis cream or ointment without success.

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I have severe scalp psoriasis covering more than 20% of my scalp.

Exclusion Criteria

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

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I have a type of psoriasis that is not plaque psoriasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score

Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90

Side effects data

From 2023 Phase 2 trial • 67 Patients • NCT04877990

25%

COVID-19

13%

Pneumonia

13%

Nasopharyngitis

Cough

Pyrexia

Mouth ulceration

Upper respiratory tract infection

Urinary tract infection

Small intestinal obstruction

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

CROHN'S DISEASE

ULCERATIVE COLITIS

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DeucravacitinibExperimental Treatment1 Intervention

Group II: Placebo then DeucravacitinibPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~320

0 / 5Eligibility 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

Deucravacitinib is a selective TYK2 inhibitor that works by blocking the TYK2 enzyme, which plays a crucial role in the signaling pathways of inflammatory cytokines involved in psoriasis. This inhibition reduces the inflammatory response and helps control the symptoms of psoriasis. Other common treatments include biologics, which target specific components of the immune system such as TNF-alpha, IL-17, and IL-23, and small molecule inhibitors like methotrexate and cyclosporine that broadly suppress the immune system. Understanding these mechanisms is important for psoriasis patients as it helps in selecting the most effective treatment with the least side effects, tailored to their specific condition and response to previous therapies.

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