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Janus Kinase (JAK) Inhibitor

Povorcitinib for Hidradenitis Suppurativa (STOP-HS2 Trial)

Verified 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
Male and female participants ≥ 18 years of age
Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit
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 skin condition that causes painful lumps and sores. The medication aims to reduce inflammation and improve symptoms over several months, with additional follow-up.

Who is the study for?
Adults over 18 with moderate to severe Hidradenitis Suppurativa (HS) for at least 3 months, having lesions in two or more areas and not responding well to conventional treatments can join. They must avoid using certain antiseptics and agree to prevent pregnancy. Excluded are those with a high number of draining tunnels, serious heart issues, blood disorders, active infections like TB or HIV, or past JAK inhibitor treatment failures.
What is being tested?
The trial is testing Povorcitinib's effectiveness and safety against a placebo in treating HS over a period of 12 weeks initially. Participants will then enter an extension phase lasting another 42 weeks to gather additional data on the drug's performance.
What are the potential side effects?
Potential side effects may include blood clotting problems; increased risk of thrombosis such as deep vein thrombosis or stroke; heart complications; abnormal liver function tests; possible reactivation of herpes virus infections; and higher susceptibility to other infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with moderate to severe HS for at least 3 months.
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I have HS and treatments so far haven't worked or I can't take them.
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I agree not to use specific skin cleaners on my HS spots during the study.
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I have HS lesions in at least two different body areas.

Timeline

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 HiSCR
Extension Period: Proportion of participants who achieve HiSCR75
Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
+15 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

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,235 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
1,907 Patients Enrolled for Hidradenitis Suppurativa

Media Library

Povorcitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05620836 — Phase 3
Hidradenitis Suppurativa Research Study Groups: Povorcitinib Dose A, Povorcitinib Dose B, Placebo
Hidradenitis Suppurativa Clinical Trial 2023: Povorcitinib Highlights & Side Effects. Trial Name: NCT05620836 — Phase 3
Povorcitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620836 — Phase 3
~75 spots leftby Mar 2025
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