Povorcitinib for HS

(STOP-LTR Trial)

Recruiting at 482 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must be taking: Povorcitinib

Must not be taking: Biologic immunomodulators, Live vaccines

Disqualifiers: Pregnancy, Breastfeeding, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 years

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain biologic drugs or live vaccines within 28 days before starting the study. It's best to discuss your specific medications with the study team.

What is the purpose of this trial?

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for individuals who have completed a previous Incyte-sponsored study of povorcitinib without safety concerns and benefited from its treatment, as judged by the researcher. Participants must be willing to prevent pregnancy or fathering children, follow the study's rules, understand and sign consent forms, and have shown good compliance with the earlier trial protocol.

Inclusion Criteria

Ability to comprehend and willingness to sign a written ICF for the study

Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements

Willingness to avoid pregnancy or fathering children as defined in the protocol

Exclusion Criteria

Had been permanently discontinued from study treatment during the parent study

Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class

Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Povorcitinib

Trial Overview The rollover study focuses on povorcitinib for those with Hidradenitis Suppurativa (HS), a chronic skin condition. It extends access to povorcitinib for participants who were previously in Incyte-sponsored trials and saw positive results.

Participant Groups

Group I: povorcitinib Experimental Treatment 1 Intervention

Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School