A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) (STOP-HS2)

Incyte

Status and phase: Enrolling; Phase 3

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: Povorcitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05620836

INCB 54707-302

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants ≥ 18 years of age.
• Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit.
• HS lesions present in ≥ 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits.
• Total abscess and inflammatory nodule (AN) count ≥ 5 at both the Screening and Baseline visits.
• History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS)
• Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
• Willingness to avoid pregnancy or fathering children.
• Other inclusion criteria apply.

Exclusion criteria

• Draining tunnel count of > 20 at Screening or Baseline visits.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
• Evidence of infection with TB, HBV, HCV or HIV.
• History of failure to JAK inhibitor treatment of any inflammatory disease.
• Laboratory values outside of the protocol-defined ranges.
• Other exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 3 patient groups, including a placebo group

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

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.

Treatment:

Drug: Placebo