A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS LTE)

Incyte

Status and phase: Enrolling; Phase 3

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: Povorcitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06212999

INCB 54707-312

2023-507204-31-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]).

Enrollment: 960 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
• Agreement to use contraception.
• Willing and able to comply with the study protocol and procedures.
• Further inclusion criteria apply.

Exclusion criteria

• Participation in the extension study could expose the participant to an undue safety risk.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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960 participants in 3 patient groups

Cohort A

Experimental group

Description:

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: Povorcitinib

Cohort B

Experimental group

Description:

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: Povorcitinib

Cohort C

Experimental group

Description:

Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Treatment:

Drug: Povorcitinib