Povorcitinib for HS
(STOP-LTR Trial)

Recruiting in Palo Alto (17 mi)

+65 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Incyte Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

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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

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Treatment Details

Interventions

Povorcitinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: povorcitinibExperimental Treatment1 Intervention

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