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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 12 through week 54
Awards & highlights

STOP-HS1 Trial Summary

This trial is testing a new drug to see if it can help treat moderate to severe HS over 12 weeks, followed by 42 weeks of extension.

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.Check my eligibility
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.See study design
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.

STOP-HS1 Trial 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.

STOP-HS1 Trial 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

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 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

STOP-HS1 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
365 Previous Clinical Trials
54,695 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: NCT05620823 — 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: NCT05620823 — Phase 3
Povorcitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620823 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort being treated with this intervention?

"To fulfill the study's requirements, 600 qualified patients must enroll. Those interested can visit one of two accredited sites; Investigative Site US323 in San Francisco or Investigative Site US306 located in Boca Raton, Florida."

Answered by AI

How many settings are being used to administer this clinical trial?

"This medical trial is available in 15 different sites, including Investigative Site US323 in San Francisco, Investigative Site US306 near Boca Raton, and the Investigative Site US320 based in Hialeah."

Answered by AI

What risks does Povorcitinib Dose A pose to individuals?

"There is evidence to confirm the safety of Povorcitinib Dose A, which receives a score of 3 in accordance with Phase 3 trials. This data supports efficacy and multiple rounds for security validation."

Answered by AI

Is it still possible for patients to enroll in this study?

"Yes, according to the data on clinicaltrials.gov this investigation is actively recruiting test subjects. It was initially posted in December 19th 2022 and has been modified as recently as January 12th 2023. 600 participants need to be recruited from 15 different sites."

Answered by AI

Who else is applying?

What site did they apply to?
Investigative Site US307
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
2022. "A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05620823.
All > Hidradenitis Suppurativa
~231 spots leftby Mar 2025
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