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

JRCT ID: jRCT2051230048

Registered date:21/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hidradenitis Suppurativa
• Date of first enrollment: 29/08/2023
• Target sample size: 600
• Countries of recruitment: Austria,Japan,Belgium,Japan,Canada,Japan,Czechia,Japan,France,Japan,Germany,Japan,Poland,Japan,Spain,Japan,United States,Japan,Greece,Japan,Netherlands,Japan
• Study type: Interventional

Intervention(s)

- Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 54 weeks.
- Povorcitinib Dose B
Participants will receive Povorcitinib Dose B for 54 weeks.
- Placebo
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.

Outcome(s)

• Primary Outcome: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 12 ]

Secondary Outcome

1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Week 12 ]
2. Proportion of participants with flare [ Time Frame: Week 12 ]
3. 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. [ Time Frame: Week 12 ]
4. Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score >= 3. [ Time Frame: Week 12 ]
5. Proportion of participants with a >= 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score [ Time Frame: Week 12 ]
6. Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit [ Time Frame: Week 54 ]
7. Mean change from baseline in abscess count at each visit [ Time Frame: Week 54 ]
8. Percentage change from baseline in abscess count at every visit [ Time Frame: Week 54 ]
9. Mean change from baseline in inflammatory nodule count at each visit [ Time Frame: Week 54 ]
10. Percentage change from baseline in inflammatory nodule count at each visit [ Time Frame: Week 54 ]
11. Mean change from baseline in draining tunnel count at each visit. [ Time Frame: Week 54 ]
12. Percentage change from baseline in draining tunnel count at each visit [ Time Frame: Week 54 ]
13. Extension Period: Proportion of participants who achieve HiSCR [ Time Frame: Week 24 ]
14. Extension Period: Proportion of participants who achieve HiSCR75 [ Time Frame: Week 24 ]
15. Extension Period: Proportion of participants with flare [ Time Frame: From Week 12 through Week 24 ]
16. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score >= 3 [ Time Frame: Week 24 ]
17. Extension Period: Proportion of participants who achieve HiSCR [ Time Frame: Week 54 ]
18. Extension Period: Proportion of participants who achieve HiSCR75 [ Time Frame: Week 54 ]
19. Extension Period : Proportion of participants with flare [ Time Frame: From Week 12 through Week 54 ]
20. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score >= 3. [ Time Frame: Week 54 ]
21. Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit [ Time Frame: From Week 12 through Week 54 ]
22. Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit [ Time Frame: From Week 12 through Week 54 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
2. Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.
3. 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.
4. 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).
5. Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
6. 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.
7. Agreement to use contraception
8. Willing and able to comply with the study protocol and procedures.
9. Further inclusion criteria apply.

Exclude criteria

1. Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
2. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
3. 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.
4. Laboratory values outside of the protocol-defined ranges.
5. Further exclusion criteria apply.

Related Information

• Primary Sponsor: Ono Shintaro
• Secondary ID(s): NCT05620823