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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 belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with moderate to severe HS for at least 3 months.
Select...
I have HS and treatments so far haven't worked or I can't take them.
Select...
I agree not to use specific skin cleaners on my HS spots during the study.
Select...
I have HS lesions in at least two different body areas.
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
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 moreAwards & 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
63,225 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
1,907 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HS and treatments so far haven't worked or I can't take them.I have tried a JAK inhibitor for an inflammatory disease and it didn't work.I have HS lesions in at least two different body areas.You have more than 20 draining tunnels during the screening or baseline visits.I agree not to use specific skin cleaners on my HS spots during the study.I am 18 years old or older.I have been diagnosed with moderate to severe HS for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Povorcitinib Dose A
- Group 2: Povorcitinib Dose B
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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