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)
Enter a location and click search to find clinical trials sorted by distance.
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