A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

JRCT ID: jRCT2051240088

Registered date:12/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hidradenitis Suppurativa
• Date of first enrollment: 10/09/2024
• Target sample size: 960
• Countries of recruitment: United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Experimental: Cohort A
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Experimental: Cohort B
Povorcitinib at the protocol-defined dose strength based on cohort assignment.
Experimental: Cohort C
Povorcitinib at the protocol-defined dose strength based on cohort assignment.

Outcome(s)

Primary Outcome

Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
[Time Frame: up to approximately 56 weeks]

Secondary Outcome

1. Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs)
[Time Frame: up to approximately 56 weeks]
2. Proportion of participants with TEAEs leading to study drug discontinuation
[Time Frame: up to approximately 56 weeks]
3. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
[Time Frame: up to approximately 56 weeks]
4. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
[Time Frame: up to approximately 56 weeks]
5. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
[Time Frame: up to approximately 56 weeks]
6. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)
[Time Frame: up to approximately 56 weeks]
7. Proportion of participants with flare at each visit
[Time Frame: up to approximately 56 weeks]
8. Time to first flare
[Time Frame: up to approximately 56 weeks]
9. Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit
[Time Frame: up to approximately 56 weeks]
10. Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit
[Time Frame: up to approximately 56 weeks]
11. Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit
[Time Frame: up to approximately 56 weeks]
12. Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit
[Time Frame: up to approximately 56 weeks]
13. Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit
[Time Frame: up to approximately 56 weeks]
14. Proportion of participants with a total AN count of 0, 1, or 2 at each visit
[Time Frame: up to approximately 56 weeks]
15. Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
[Time Frame: up to approximately 56 weeks]

Key inclusion & exclusion criteria

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

Include criteria

1. Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
2. Agreement to use contraception.
3. Willing and able to comply with the study protocol and procedures.
4. Further inclusion criteria apply.

Exclude criteria

1. Participation in the extension study could expose the participant to an undue safety risk.
2. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
3. Further exclusion criteria apply.

Related Information

• Primary Sponsor: Ono Shintaro
• Secondary ID(s): NCT06212999