Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, Hidradenitis, Acne inversa, HS, INCB054707, Povorcitinib
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
* 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
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 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 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 at each visit | 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 at each visit. | 54 weeks | Defined as mean change of Abscess count relative to baseline. |
| Percentage change from baseline in abscess count at every visit | 54 weeks | Percent change from baseline in number of abscess(es) |
| Mean change from baseline in inflammatory nodule count at each visit | 54 weeks | Defined as mean change of inflammatory nodule count relative to baseline. |
| Percentage change from baseline in inflammatory nodule count at each visit. | 54 weeks | Defined as percent change from baseline in number of inflammatory nodule(s) |
| Mean change from baseline in draining tunnel count at each visit. | 54 weeks | Defined as mean change of draining tunnel count relative to baseline. |
| Percentage change from baseline in draining tunnel count at each visit. | 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 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 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. |
| 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. |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Greece, Japan, Netherlands, Poland, Spain, United States
Outcome results
None listed