What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa, particularly JAK inhibitors like Ruxolitinib, can have several side effects. These include an increased risk of serious infections, malignancy, and laboratory abnormalities. Other treatments for HS, such as systemic glucocorticoids, can cause adverse effects like gastrointestinal upset, weight gain, and increased susceptibility to infections. Topical treatments, like clindamycin, may cause local skin irritation. Overall, while these treatments can be effective, they come with significant potential side effects that need to be managed under medical supervision.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for the treatment of Hidradenitis Suppurativa (HS). However, it does reference the use of Janus kinase (JAK) inhibitors, such as ruxolitinib, which is being studied for HS. Other treatments for HS mentioned include systemic glucocorticoids, botulinum toxin A, and various biologic agents. Further studies and clinical trials are ongoing to confirm the efficacy and safety of these treatments.

What other types of research exist?

Promising novel alternatives to Ruxolitinib cream for Hidradenitis Suppurativa patients include IL-17 inhibitors and dupilumab. IL-17 inhibitors target the IL-17 pathway, which is implicated in HS, and have shown positive treatment outcomes in clinical studies. Dupilumab, an IL-4/IL-13 dual blocker, has been successfully used to treat severe HS, suggesting its potential as an effective alternative.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Hidradenitis Suppurativa

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.

Baseline Skin Pain or Itch NRS score ≥ 1.

Must not have

Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline

Presence of draining tunnels at screening or at baseline visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 40 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medicated cream called Ruxolitinib on people with a painful skin condition called Hidradenitis Suppurativa. The cream works by blocking enzymes that cause inflammation and swelling. The study will last for several months, with additional treatment time for those who complete the first part.

Who is the study for?

This trial is for individuals with Hidradenitis Suppurativa (HS), a skin condition, who have had it for at least 3 months. Participants should have a certain number of painful or itchy skin bumps in specific areas without tunnels. They must not use antibiotics or certain antiseptic washes during the study and agree to avoid pregnancy.

What is being tested?

The study tests Ruxolitinib cream's effectiveness and safety against HS compared to a placebo cream over 16 weeks, followed by all participants receiving Ruxolitinib for another 16 weeks. It's randomized and double-blind initially, meaning neither researchers nor participants know who gets which treatment.

What are the potential side effects?

While the side effects are not specified here, generally topical treatments like creams can cause local reactions such as redness, itching, burning sensation at the application site; systemic side effects are less common but may include headaches or fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I agree not to use any antibiotics for HS during the study.

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I experience skin pain or itching.

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I have 3 to 10 painful skin bumps without any tunnels.

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I agree not to use any antibiotics for HS during the study.

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I experience skin pain or itching.

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I agree not to use certain skin cleansers on my HS lesions during the study.

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I have been diagnosed with HS for at least 3 months.

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I have mild to moderate HS with 3 to 10 active nodules and no tunnels.

Exclusion Criteria

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

Select...

I have not had a skin infection like herpes or chicken pox in the last 2 weeks.

Select...

I have draining tunnels in my skin.

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I do not have skin conditions that could affect HS assessment.

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I have a condition that weakens my immune system.

Select...

I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 weeks 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 abscess and inflammatory nodules (AN) count at Week 16.

Secondary study objectives

Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score

Change from baseline in the Itch NRS score

Change from baseline in the Skin Pain Numeric Rating Scale (NRS)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vehicle CreamExperimental Treatment1 Intervention

Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

Group II: Ruxolitinib CreamExperimental Treatment1 Intervention

Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vehicle cream

2011

Completed Phase 3

~5360

Ruxolitinib cream

2022

Completed Phase 3

~1850

0 / 13Eligibility 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. Janus kinase (JAK) inhibitors, such as Ruxolitinib, work by blocking the JAK-STAT signaling pathway, which is involved in the inflammatory response. By inhibiting this pathway, JAK inhibitors reduce the production of pro-inflammatory cytokines, thereby decreasing inflammation and lesion formation in HS. This is crucial for HS patients as it helps manage symptoms, reduce flare-ups, and improve quality of life. Other treatments, like TNF-alpha inhibitors, also target specific inflammatory pathways, further highlighting the importance of controlling inflammation in HS management.