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Janus Kinase Inhibitor

Cohort C 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
Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
Agreement to use contraception.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 56 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

STOP-HS LTE 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.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.

STOP-HS LTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have finished taking the treatment in the previous study (INCB 54707-301 or INCB 54707-302).
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You agree to use birth control.
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You are ready and able to follow the study rules and steps.
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This means that there are more requirements that need to be met in order to participate in the study.

STOP-HS LTE Trial 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

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 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.

STOP-HS LTE 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.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
357 Previous Clinical Trials
53,978 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
1,547 Patients Enrolled for Hidradenitis Suppurativa
Incyte Medical MonitorStudy DirectorIncyte Corporation
21 Previous Clinical Trials
4,064 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are participating in the entirety of this clinical trial?

"A total of 960 eligible participants are required for enrollment in this research. Patients have the opportunity to join from various locations, including Investigative Site US224 based in Baltimore, Maryland and Investigative Site CA205 located in Fredericton, New Brunswick."

Answered by AI

Are there multiple locations conducting this research within the state?

"The current scope of this research initiative spans across 176 medical facilities. These sites are dispersed widely, with key locations including Baltimore, Fredericton, and San Francisco among the others. Opting for a site in close proximity can aid in reducing travel obligations for participants."

Answered by AI

Are there any associated risks with Cohort C for the participants?

"Based on our assessment at Power, the safety rating for Cohort C in this trial is 3. This reflects a Phase 3 investigation with existing efficacy data and robust records of safety profiles."

Answered by AI
~640 spots leftby Dec 2026