Status:

RECRUITING

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Lead Sponsor:

Incyte Corporation

Conditions:

Hidradenitis Suppurativa (HS)

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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

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.

Key Trial Info

Start Date :

February 28 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 28 2028

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT06855498

Start Date

February 28 2025

End Date

February 28 2028

Last Update

April 8 2026

Active Locations (316)

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Page 1 of 79 (316 locations)

1

Investigative Site US086

Birmingham, Alabama, United States, 35244

2

Investigative Site US098

Montgomery, Alabama, United States, 36117

3

Investigative Site US004

Phoenix, Arizona, United States, 85006

4

Investigative Site US047

Scottsdale, Arizona, United States, 85255

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib | DecenTrialz