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

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.

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.