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

Sponsor

Incyte Corporation (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05620836

Collaborator

(none)

600

Enrollment

Arms

37.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa (HS)	Drug: Povorcitinib Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or Placebo once a day (QD); participants who complete the placebo-controlled (PC) 12-week period may continue to a 42-week extension (EXT) period with Povorcitinib (Dose A or Dose B) QD.Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or Placebo once a day (QD); participants who complete the placebo-controlled (PC) 12-week period may continue to a 42-week extension (EXT) period with Povorcitinib (Dose A or Dose B) QD.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Anticipated Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

Mar 11, 2025

Anticipated Study Completion Date :

Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Povorcitinib Dose A Participants will receive Povorcitinib Dose A for 54 weeks.	Drug: Povorcitinib Oral, Tablet Other Names: INCB054707
Experimental: Povorcitinib Dose B Participants will receive Povorcitinib Dose B for 54 weeks.	Drug: Povorcitinib Oral, Tablet Other Names: INCB054707
Placebo Comparator: Placebo Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.	Drug: Placebo Oral, Tablet

Arm

Intervention/Treatment

Experimental: Povorcitinib Dose A

Participants will receive Povorcitinib Dose A for 54 weeks.

Drug: Povorcitinib

Oral, Tablet

Other Names:

INCB054707

Experimental: Povorcitinib Dose B

Participants will receive Povorcitinib Dose B for 54 weeks.

Drug: Povorcitinib

Oral, Tablet

Other Names:

INCB054707

Placebo Comparator: Placebo

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

Drug: Placebo

Oral, Tablet

Outcome Measures

Primary Outcome Measures

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [Week 12]
HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

Secondary Outcome Measures

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Week 12]
HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Proportion of participants with flare [12 Weeks]
Participants who experience at least 1 flare over 12 weeks; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.
Proportion of participants with a ≥ 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score ≥ 3 [Week 12]
Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score at Week 12, relative to baseline. Skin Pain is an 11-point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).
Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3. [Week 12]
Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 12 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score [Week 12]
Participants with a baseline FACIT-F score ≤ 48 and who experience at least a 4-point increase in FACIT-F score at Week 12, relative to baseline. The FACIT-F scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days, with scores ranging from 0 (worst fatigue) to 52 (no fatigue).
Mean change from baseline in Dermatology Life Quality Index (DLQI) score [54 weeks]
The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (QoL). The DLQI total score ranges from 0 to 30, with higher scores indicating lower skin health related QoL.
Mean change from baseline in abscess count [54 weeks]
Defined as mean change of abscess(es) count relative to baseline.
Percentage change from baseline in abscess count [54 weeks]
Percent Change from baseline in number of abscess(es)
Mean change from baseline in inflammatory nodule count [54 weeks]
Defined as mean change of inflammatory nodule count relative to baseline.
Percentage change from baseline in inflammatory nodule count [54 weeks]
Defined as percent change from baseline in number of inflammatory nodule(s)
Mean change from baseline in draining tunnel count [54 weeks]
Defined as mean change of draining tunnel count relative to baseline.
Percentage change from baseline in draining tunnel count [54 weeks]
Defined as Percent change from baseline in number of draining tunnel(s)
Extension Period: Proportion of participants who achieve HiSCR [Week 24]
HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Extension Period: Proportion of participants who achieve HiSCR75 [Week 24]
HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Extension Period: Proportion of participants with flare [From Week 12 through Week 24]
Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. [Week 24]
Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Extension Period: Proportion of participants who achieve HiSCR [Week 54]
HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Extension Period: Proportion of participants who achieve HiSCR75 [Week 54]
HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
Extension Period: Proportion of participants with flare [From Week 12 through Week 54]
Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. [Week 54]
Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Extension Period: Proportion of participants who achieve maintenance of HiSCR or greater response at each visit [From Week 12 through Week 54]
Maintenance of response defined as participants who achieve HiSCR at Week 12 and maintain it or achieve greater response at each visit during the EXT period.
Extension Period: Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit [From Week 12 through Week 54]
Maintenance of response defined as participants who achieve HiSCR75 at Week 12 and maintain it or achieve greater response at each visit during the EXT period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.