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.
Brief Title
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Hidradenitis Suppurativa (HS)
Eligibility Criteria
Inclusion Criteria:
* 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage 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 NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
* Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
* 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.
* 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage 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 NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
* Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage 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 NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
* Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
* Agreement to use contraception
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.
* 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage 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 NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
* Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
* Agreement to use contraception
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.
Gender
All
Gender Based
false
Keywords
Hidradenitis Suppurativa
Hidradenitis
Acne inversa
HS
INCB054707
Povorcitinib
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05620823
Org Class
Industry
Org Full Name
Incyte Corporation
Org Study Id
INCB 54707-301
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Outcome Time Frame
Week 12
Secondary Ids
Secondary Id
2022-501752-29-00
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Outcome Description
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.
Outcome Time Frame
12 weeks
Outcome Measure
Proportion of participants with flare
Outcome Description
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).
Outcome Time Frame
Week 12
Outcome Measure
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.
Outcome Description
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.
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
Outcome Description
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).
Outcome Time Frame
Week 12
Outcome Measure
Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score
Outcome Description
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.
Outcome Time Frame
54 weeks
Outcome Measure
Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit
Outcome Description
Defined as mean change of Abscess count relative to baseline.
Outcome Time Frame
54 weeks
Outcome Measure
Mean change from baseline in abscess count at each visit.
Outcome Description
Percent change from baseline in number of abscess(es)
Outcome Time Frame
54 weeks
Outcome Measure
Percentage change from baseline in abscess count at every visit
Outcome Description
Defined as mean change of inflammatory nodule count relative to baseline.
Outcome Time Frame
54 weeks
Outcome Measure
Mean change from baseline in inflammatory nodule count at each visit
Outcome Description
Defined as percent change from baseline in number of inflammatory nodule(s)
Outcome Time Frame
54 weeks
Outcome Measure
Percentage change from baseline in inflammatory nodule count at each visit.
Outcome Description
Defined as mean change of draining tunnel count relative to baseline.
Outcome Time Frame
54 weeks
Outcome Measure
Mean change from baseline in draining tunnel count at each visit.
Outcome Description
Defined as percent change from baseline in number of draining tunnel(s)
Outcome Time Frame
54 weeks
Outcome Measure
Percentage change from baseline in draining tunnel count at each visit.
Outcome Description
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.
Outcome Time Frame
Week 24
Outcome Measure
Extension Period: Proportion of participants who achieve HiSCR
Outcome Description
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.
Outcome Time Frame
Week 24
Outcome Measure
Extension Period: Proportion of participants who achieve HiSCR75
Outcome Description
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.
Outcome Time Frame
From Week 12 through Week 24
Outcome Measure
Extension Period: Proportion of participants with flare
Outcome Description
Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
Outcome Time Frame
Week 24
Outcome Measure
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3
Outcome Description
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
Outcome Time Frame
Week 54
Outcome Measure
Extension Period: Proportion of participants who achieve HiSCR
Outcome Description
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.
Outcome Time Frame
Week 54
Outcome Measure
Extension Period: Proportion of participants who achieve HiSCR75
Outcome Description
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.
Outcome Time Frame
From Week 12 through Week 54
Outcome Measure
Extension Period : Proportion of participants with flare
Outcome Description
Participants with a Skin Pain score of at least 3 at baseline and who achieve at 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.
Outcome Time Frame
Week 54
Outcome Measure
Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.
Outcome Description
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.
Outcome Time Frame
From Week 12 through Week 54
Outcome Measure
Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit
Outcome Description
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.
Outcome Time Frame
From Week 12 through Week 54
Outcome Measure
Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741