What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include antibiotics, hormonal therapy, biologics, and immunosuppressants. Antibiotics can cause gastrointestinal issues and antibiotic resistance. Hormonal therapies may lead to menstrual irregularities and mood changes. Biologics, such as TNF inhibitors, can increase the risk of infections and injection site reactions. Immunosuppressants like cyclosporine can cause kidney dysfunction and hypertension. For treatments similar to Deucravacitinib, such as other JAK inhibitors, side effects may include increased risk of infections, elevated liver enzymes, and blood clots.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa, with the most notable being adalimumab (Humira), a TNF-alpha inhibitor, which was the first biologic approved for moderate to severe HS. Other treatments under investigation include biologics targeting different pathways, such as IL-17 inhibitors. Deucravacitinib, a selective TYK2 inhibitor, is currently being studied, and while it is not yet approved, it represents a novel approach targeting the JAK-STAT pathway, which is different from the mechanisms of previously approved treatments.

What other types of research exist?

Promising novel alternatives to Deucravacitinib for Hidradenitis Suppurativa patients include: 1) Alectinib, an ALK inhibitor, which has shown durable responses in other inflammatory conditions. 2) Secukinumab, an IL-17A inhibitor, which has demonstrated efficacy in various inflammatory and autoimmune conditions. 3) Infliximab, a TNF-alpha inhibitor, which has been effective in treating severe, recalcitrant inflammatory conditions. These alternatives have shown potential in clinical studies and could be considered for HS treatment in 2024.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Hidradenitis Suppurativa

Phase 2

Recruiting

Led By Alexandra Kimball, MD, MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

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

Must have

Have HS lesions in 2 distinct anatomical areas

Male or Female at least 18 -70 years of age

Must not have

Receipt of TNF agents (i.e. Infliximab, adalimumab) or other biologics within 6 weeks prior to baseline

Known infection with HIV, hepatitis B or hepatitis C at screening or randomization. Patients who are Hepatitis B Core antibody and/or Hep B Surface Antigen positive will be excluded from this study. Patients who are Hepatitis C ab positive will also be excluded from this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 4, 8, 12, and 16

Summary

This trial tests if Deucravacitinib can help adults with Hidradenitis Suppurativa by reducing inflammation and painful lumps through calming the immune system.

Who is the study for?

Adults aged 18-70 with Hidradenitis Suppurativa (HS), having at least 5 abscesses or nodules and lesions in two areas. Women must test negative for pregnancy and use birth control; men cannot be trying to conceive. Excludes those with uncontrolled conditions, recent certain treatments, allergies to tetracycline antibiotics, active skin diseases that could affect HS assessment, current malignancy or history of one within the past five years (except specific treated cancers), chronic infections including HIV/Hepatitis B/C, and those on opioid analgesics.

What is being tested?

The trial is testing Deucravacitinib's safety and effectiveness against a placebo in treating HS. Participants will randomly receive either Deucravacitinib (6 mg twice daily) or a placebo for 16 weeks. The study includes a screening period before treatment starts and follows up four weeks after the last dose via phone call.

What are the potential side effects?

While not specified here, potential side effects of Deucravacitinib may include infection risk increase due to immune system changes, liver issues, high blood pressure, headaches or dizziness. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have HS lesions in two different body areas.

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I am between 18 and 70 years old.

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I agree to use effective birth control during the study.

Exclusion Criteria

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

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I haven't taken TNF inhibitors or other biologic drugs in the last 6 weeks.

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I do not have HIV, hepatitis B, or hepatitis C.

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I started a new hormonal treatment for HS less than 3 weeks ago.

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I am not pregnant, breastfeeding, nor planning to become pregnant. I am also not trying to conceive.

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I haven't taken non-biologic treatments for HS, except antibiotics or hormones, in the last 4 weeks.

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I have more than 20 draining fistulas.

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I have a long-term or frequently returning infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 4, 8, 12, and 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 4, 8, 12, and 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12, and 16 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Inflammatory lesion counts (including combined counts of inflammatory nodules (N) and abscesses (A)/AN count) at week 16.

Secondary study objectives

Changes in Dermatology Life Quality Index (DLQI) scores at weeks 4, 8, 12, and 16 compared to baseline.

Changes in Hurley Stage scores at weeks 4, 8, 12, and 16 compared to baseline.

Changes in IHS4 scores at weeks 4, 8, 12, and 16 compared to baseline.

+2 more

Other study objectives

Change in clinical phenotype at week 16 compared to baseline.

Changes in lesion counts (A, N, AN) at weeks 4, 8, and 12 compared to baseline.

Changes in ulceration at weeks 4, 8, 12, and 16 compared to baseline.

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Deucravacitinib - Study DrugExperimental Treatment1 Intervention

Deucravacitinib group: 6 mg po bid x 16 weeks

Group II: PlaceboPlacebo Group1 Intervention

Placebo group: 1 tablet po bid x 16 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~160

0 / 10Eligibility 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

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses. Common treatments for HS often target the immune system to reduce inflammation and prevent flare-ups. Biologic agents, such as TNF-alpha inhibitors (e.g., adalimumab), work by blocking specific inflammatory pathways involved in HS. Deucravacitinib, a selective TYK2 inhibitor, targets the TYK2 enzyme, which plays a crucial role in the signaling pathways of several cytokines involved in the inflammatory process. By inhibiting TYK2, Deucravacitinib can potentially reduce the inflammatory response and improve symptoms in HS patients. Understanding these mechanisms is important for patients as it highlights the rationale behind using immune-modulating therapies to manage their condition effectively.