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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
STOP-HS2 Trial Summary
This trial tests a new drug to treat painful skin condition hidradenitis suppurativa over a 54-week period.
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.Check my eligibility
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.See study design
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.
STOP-HS2 Trial 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.
STOP-HS2 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hidradenitis
Secondary outcome measures
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 moreSTOP-HS2 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.
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,565 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research currently in the process of enrolling participants?
"The clinical trial is actively recruiting patients, as evidenced by the information posted on clinicaltrials.gov. This research endeavor was originally advertised on February 22nd 2023 and updated to its current version March 1st 2023."
Answered by AI
Is Povorcitinib Dose B associated with any potential risks for patients?
"Our team has rated the safety of Povorcitinib Dose B as a 3 due to prior research demonstrating efficacy and numerous rounds of data confirming its security."
Answered by AI
What is the scope of participants in this medical research?
"This trial necessitates the enrollment of 600 individuals that meet its specified inclusion criteria. Applicants have a choice between Investigative Site US226 in San Diego, Florida and Investigative Site US222 in San Francisco, Illinois."
Answered by AI
Are there multiple Canadian sites that are facilitating this clinical investigation?
"Apart from the previously mentioned Investigative Sites in San Diego, Florida and Brandon, Indiana; this trial is also recruiting patients at US222 located in San Francisco as well twenty-nine other research centres."
Answered by AI
Who else is applying?
What site did they apply to?
Investigative Site US221
Investigative Site US229
Clinical Trials Management - Southshore
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
Want better understanding of HS and treatments. I’ve had 6 surgeries the last 2 happened last week! I’m tired of this!
PatientReceived 2+ prior treatments
I'm tired of dealing with this condition and I'll do what I can to help find effective treatment.
PatientReceived 2+ prior treatments
Humira does not currently interact with the mode of action of my ART, but I would like alternatives when it does.
PatientReceived no prior treatments
For years I have been getting these boils/absesses and I would go have drained/treated take antibiotics. Then it constantly repeats the cycle. I have been doing more research and really sounds like it is HS. So trying to find out more in hopes of getting the condition to improve.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Clinical Trials Management - Southshore: < 24 hours
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