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

Incyte

Status and phase: Not yet enrolling; Phase 2

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: Povorcitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07213973

INCB054707-211

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.
• Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
• Agreement to use contraception.
• Willing and able to comply with the study protocol and procedures.
• Further inclusion criteria apply.

Exclusion criteria

• 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.
• Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Povorcitinib Dose A

Experimental group

Description:

Participants will receive povorcitinib dose A for 54 weeks.

Treatment:

Drug: Povorcitinib

Povorcitinib Dose B

Experimental group

Description:

Participants will receive povorcitinib dose B for 54 weeks.

Treatment:

Drug: Povorcitinib