Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Purpose

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

Condition

  • Hidradenitis Suppurativa (HS)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
povorcitinib
Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.
  • Drug: povorcitinib
    Study drug will be taken orally as defined by the protocol.

Recruiting Locations

Investigative Site US004
Phoenix, Arizona 85006

Investigative Site US002
Boca Raton, Florida 33486

Investigative Site US005
Tampa, Florida 33613

Investigative Site US001
Tampa, Florida 33615

Investigative Site US003
Spokane, Washington 99202

More Details

NCT ID
NCT06855498
Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com