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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
No Placebo-Only Group
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to approximately 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 56 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Secondary study objectives
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)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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.
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
62,875 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
11,093 Total Patients Enrolled
~640 spots leftby Dec 2026
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