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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

NCT06855498

RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: Hidradenitis Suppurativa (HS)

Interventions: povorcitinib

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations (318)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
Fremont, California, United States
Huntington Beach, California, United States
Irvine, California, United States
Laguna Niguel, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Oakland, California, United States
Santa Monica, California, United States
Sherman Oaks, California, United States
Sunnyvale, California, United States
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Coral Gables, Florida, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
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