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

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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

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

Trial contacts and locations

176

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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