Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib (STOP-LTR)

Incyte

Status and phase

Enrolling

Phase 3

Conditions

Hidradenitis Suppurativa (HS)

Treatments

Drug: povorcitinib

Study type

Interventional

Funder types

Industry

Identifiers

INCB054707-801

2024-520107-12-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to comprehend and willingness to sign a written ICF for the study.
Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
Willingness to avoid pregnancy or fathering children as defined in the protocol.
Willingness and ability to comply with the study Protocol and procedures.

Exclusion criteria

Had been permanently discontinued from study treatment during the parent study.
Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:
- Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
- Live, attenuated vaccine.
Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
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.
Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.