Suspended

STOP-HS LTEPovorcitinib's Long-Term Safety and Efficacy in Moderate to Severe Hidradenitis Suppurativa

Study Aim

This study aims to evaluate the long-term safety and effectiveness of Povorcitinib in treating moderate to severe Hidradenitis Suppurativa, focusing on the proportion of participants experiencing treatment-related adverse events.

What is being tested

Povorcitinib

Drug

Who is being recruted

Bacterial Infections and Mycoses+8

+ Bacterial Infections

+ Infections

Over 18 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: January 2024

See protocol details

Summary

Principal SponsorIncyte Corporation

Last updated: March 24, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 30, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on understanding how safe and effective a drug called povorcitinib is when used over a long period in people who have moderate to severe hidradenitis suppurativa. Hidradenitis suppurativa is a painful, long-term skin condition that causes lumps under the skin, mostly in areas where skin rubs together. The study specifically targets those who have already participated in and completed previous related studies, ensuring that the participants have a history with the treatment. This research is important because finding a reliable and safe treatment could significantly improve the quality of life for people suffering from this challenging skin condition. Participants in this study will continue to receive povorcitinib, although the exact method of administration isn't specified, it is likely to be similar to the previous studies they completed. The study does not outline specific outcomes it will measure, but generally, it aims to monitor both the safety of the drug over a longer period and how effectively it manages the symptoms of hidradenitis suppurativa. Since this is a continuation of earlier studies, any risks or benefits would be consistent with what was previously observed, focusing on ensuring the drug remains safe and beneficial over time.

Official TitleA Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

NCT06212999

Principal SponsorIncyte Corporation

Last updated: March 24, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

617 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfectionsSkin DiseasesSkin Diseases, InfectiousSuppurationSweat Gland DiseasesHidradenitisSkin Diseases, BacterialSkin and Connective Tissue DiseasesHidradenitis Suppurativa

Criteria

4 inclusion criteria required to participate

Agreement to use contraception

Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302)

Further inclusion criteria apply

Willing and able to comply with the study protocol and procedures

3 exclusion criteria prevent from participating

Women who are pregnant (or who are considering pregnancy) or breastfeeding

Further exclusion criteria apply

Participation in the extension study could expose the participant to an undue safety risk

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Group II

Experimental

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Group III

Experimental

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 165 locations

Suspended

Investigative Site US213

Fort Gratiot, United StatesOpen Investigative Site US213 in Google Maps

Suspended

Investigative Site FR206

Reims, France

Suspended

Investigative Site FR202

Rouen, France

Suspended

Investigative Site FR301

Saint-Priest-en-Jarez, France

Suspended165 Study Centers