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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental povorcitinib |
Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled. |
|
Recruiting Locations
Phoenix, Arizona 85006
Boca Raton, Florida 33486
Tampa, Florida 33613
Tampa, Florida 33615
Spokane, Washington 99202
More Details
- NCT ID
- NCT06855498
- Status
- Recruiting
- Sponsor
- Incyte Corporation