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Janus Kinase Inhibitor
Povorcitinib for Hidradenitis Suppurativa (STOP-HS LTE 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
Be older than 18 years old
Must not have
Women who are pregnant (or who are considering pregnancy) or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 56 weeks
Awards & highlights
Summary
This trial aims to assess the safety and effectiveness of povorcitinib over a long period in people with moderate to severe hidradenitis suppurativa who have already completed 54 weeks of treatment
Who is the study for?
This trial is for people with moderate to severe hidradenitis suppurativa who finished the treatment period in earlier Phase 3 studies (INCB 54707-301 or INCB 54707-302). Participants must agree to use contraception and follow the study rules.Check my eligibility
What is being tested?
The trial is testing Povorcitinib's long-term safety and effectiveness. It's for those who've already been on it during previous trials, aiming to understand how well it works over a longer period and if there are any ongoing risks.See study design
What are the potential side effects?
While specific side effects of Povorcitinib aren't listed here, they may include typical drug reactions such as skin irritation at the application site, nausea, headaches, or other common medication-related issues.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, considering pregnancy, or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 56 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit
Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
+12 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Group II: Cohort BExperimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Group III: Cohort AExperimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
373 Previous Clinical Trials
54,819 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
1,547 Patients Enrolled for Hidradenitis Suppurativa
Incyte Medical MonitorStudy DirectorIncyte Corporation
26 Previous Clinical Trials
4,393 Total Patients Enrolled
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