What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include antibiotics, biologics like infliximab, and immunomodulatory agents such as zinc gluconate. For treatments similar to Povorcitinib, which is a Janus kinase (JAK) inhibitor, known side effects from other JAK inhibitors include increased risk of infections, gastrointestinal upset, and potential for malignancy. Specifically, JAK inhibitors like tofacitinib have been associated with serious infections, laboratory abnormalities, and increased risk of malignancies. Other common side effects of HS treatments can include gastrointestinal issues, arthralgias, and loss of efficacy over time.

What prior FDA approvals exist?

As of now, the FDA has approved adalimumab (Humira) for the treatment of moderate to severe Hidradenitis Suppurativa. Adalimumab is a TNF-alpha inhibitor and is the first and only FDA-approved medication specifically for HS. While there are no FDA-approved JAK inhibitors for HS, other JAK inhibitors like tofacitinib and ruxolitinib have shown efficacy in treating related inflammatory conditions, suggesting potential for future approvals in HS treatment.

What other types of research exist?

Promising novel alternatives to Povorcitinib for Hidradenitis Suppurativa patients include biologics such as Adalimumab (an anti-TNF agent) and emerging therapies like Bimekizumab (an IL-17A and IL-17F inhibitor) and Secukinumab (an IL-17A inhibitor). These treatments have shown efficacy in clinical trials for moderate to severe HS and offer different mechanisms of action compared to JAK inhibitors.

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Janus Kinase (JAK) Inhibitor

Povorcitinib for Hidradenitis Suppurativa (STOP-HS1 Trial)

Phase 3

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

HS lesions in at least 2 distinct anatomical areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits

Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy for HS

Must not have

Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 12 through week 54

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called Povorcitinib to see if it helps people with moderate to severe Hidradenitis Suppurativa (HS). HS is a painful skin condition that often doesn't respond well to regular treatments. Povorcitinib aims to reduce inflammation and other symptoms by calming the immune system.

Who is the study for?

This trial is for people with moderate to severe Hidradenitis Suppurativa (HS) who haven't responded well to other treatments. Participants need at least 5 abscesses or nodules, must avoid certain HS treatments during the study, and agree to use contraception. It's not for those with more than 20 draining tunnels, pregnant or breastfeeding women, or individuals with specific medical conditions.

What is being tested?

The study tests Povorcitinib's effectiveness and safety in treating HS over a 12-week period against a placebo. After that, there's a 42-week extension phase. The goal is to see if Povorcitinib can help reduce symptoms of HS better than no treatment.

What are the potential side effects?

While the side effects of Povorcitinib are not detailed here, common drug-related side effects may include skin reactions at the site of application, gastrointestinal issues like nausea or diarrhea, potential liver enzyme elevations, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have HS lesions in 2 different areas, one is moderate or severe.

Select...

I have HS and treatments for over 3 months haven't worked.

Exclusion Criteria

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

Select...

I have more than 20 draining tunnels (fistulas).

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 12 through week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 12 through week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 through week 54 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hidradenitis

Secondary study objectives

Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit

Extension Period : Proportion of participants with flare

Extension Period: Proportion of participants who achieve HiSCR

+17 more

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: Povorcitinib Dose BExperimental Treatment1 Intervention

Participants will receive Povorcitinib Dose B for 54 weeks.

Group II: Povorcitinib Dose AExperimental Treatment1 Intervention

Participants will receive Povorcitinib Dose A for 54 weeks.

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Povorcitinib

2024

Completed Phase 1

~170

0 / 4Eligibility 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, and its treatment often involves targeting the underlying immune dysregulation. Janus kinase (JAK) inhibitors, such as Povorcitinib, work by blocking the JAK-STAT signaling pathway, which is crucial for the activity of various inflammatory cytokines involved in HS. By inhibiting this pathway, JAK inhibitors reduce inflammation and immune response, leading to decreased lesion formation and symptom relief. Other common treatments include antibiotics to control secondary infections, anti-inflammatory drugs to reduce inflammation, and surgical interventions for severe cases. Understanding these mechanisms is vital for HS patients as it helps in selecting appropriate therapies that target specific aspects of the disease, potentially improving outcomes and quality of life.

Management of hidradenitis suppurativa.