Hidradenitis Suppurativa (HS)
Conditions
Keywords
INCB054707, povorcitinib, Hidradenitis Suppurativa, Hidradenitis, HS
Brief summary
Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.
Interventions
DRUGpovorcitinib
Study drug will be taken orally as defined by the protocol.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 3 years | Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit | Up to approximately 3 years | ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed