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

Sponsors and collaborators