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A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS LTE)

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

Ono Shintaro

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

jpmedinfo@incyte.com

Medical Information Center

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

+81-120-094-139

jpmedinfo@incyte.com

Recruiting

July. 13, 2024

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

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.

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.

Both

Hidradenitis Suppurativa

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.

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

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]

+81-75-251-5873

June. 06, 2024

Yes

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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