Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-17
SponsorIncyte Corporation

About this trial

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.

Eligibility criteria

Qualifiers

Aged ≥ 12 to < 18 years at the time of informed consent/assent signing.

Body weight ≥ 30 kg at both screening and baseline visits.

Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.

Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.

Disqualifiers

Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.

Women who are pregnant (or who are considering pregnancy) or breastfeeding.

Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.

Laboratory values outside of the protocol-defined ranges.

Trial design

Treatments tested in this trial

  • Povorcitinib

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

30
Canada
Dermcare ClinicL4W 0C2, MississaugaOntario, Canada
York Dermatology CenterL4B 1L1, Richmond HillOntario, Canada
The Hospital For Sick ChildrenM5G 1X8, TorontoOntario, Canada
Skincare Studio Dermatology CentreA1E 1V4, St. John's Canada

Sponsors and collaborators

Incyte Corporation

Lead sponsor