Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib (NCT06855498) | Clinical Trial Compass
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
United States600 participantsStarted 2025-02-28
Plain-language summary
Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.
Who can participate
Age range18 Years
SexALL
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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 produ…
What they're measuring
1
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)