Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation
About this trial
Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
Live, attenuated vaccine.
Trial design
Design model
Single group
Treatments tested in this trial
povorcitinib
DrugStudy drug will be taken orally as defined by the protocol.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: povorcitinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Adverse events either reported for the first time in this Protocol or any AE ongoing and defined as treatment-emergent from the parent Protocol.
Time frame
Up to approximately 3 yearsSecondary outcomes
1
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
Time frame
Up to approximately 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov