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Janus Kinase Inhibitor

Cohort B 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 56 weeks

Awards & highlights

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 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

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

365 Previous Clinical Trials

54,335 Total Patients Enrolled

7 Trials studying Hidradenitis Suppurativa

1,547 Patients Enrolled for Hidradenitis Suppurativa

Incyte Medical MonitorStudy DirectorIncyte Corporation

23 Previous Clinical Trials

4,112 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