Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis
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.
Interventions
DRUGPovorcitinib
Oral, Tablet
DRUGPlacebo
Oral, Tablet
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| Percentage change from baseline in inflammatory nodule count | 54 weeks | Defined as percent change from baseline in number of inflammatory nodule(s) |
Countries
Australia, Bulgaria, Canada, Denmark, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Outcome results
None listed