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NCT05620823 Clinical Trial

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

Hidradenitis Suppurativa (HS) Clinical Trial

— STOP-HS1  

Official title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05620823
Other study ID # INCB 54707-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 19, 2022
Est. completion date January 30, 2026

Study information
Verified date May 2024
Source Incyte Corporation
Contact Incyte Corporation Call Center (US)
Phone 1.855.463.3463
Email medinfo@incyte.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Povorcitinib
Oral; Tablet
• Placebo
Oral; Tablet
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Sponsors (1)
Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Greece,  Japan,  Netherlands,  Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) 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. Week 12
Secondary Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) 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. Week 12
Secondary Proportion of participants with flare 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. 12 weeks
Secondary 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. 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). Week 12
Secondary Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3. 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. Week 12
Secondary Proportion of participants with a = 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score 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). Week 12
Secondary Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit 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. 54 weeks
Secondary Mean change from baseline in abscess count at each visit. Defined as mean change of Abscess count relative to baseline. 54 weeks
Secondary Percentage change from baseline in abscess count at every visit Percent change from baseline in number of abscess(es) 54 weeks
Secondary Mean change from baseline in inflammatory nodule count at each visit Defined as mean change of inflammatory nodule count relative to baseline. 54 weeks
Secondary Percentage change from baseline in inflammatory nodule count at each visit. Defined as percent change from baseline in number of inflammatory nodule(s) 54 weeks
Secondary Mean change from baseline in draining tunnel count at each visit. Defined as mean change of draining tunnel count relative to baseline. 54 weeks
Secondary Percentage change from baseline in draining tunnel count at each visit. Defined as percent change from baseline in number of draining tunnel(s) 54 weeks
Secondary Extension Period: Proportion of participants who achieve HiSCR 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. Week 24
Secondary Extension Period: Proportion of participants who achieve HiSCR75 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. Week 24
Secondary Extension Period: Proportion of participants with flare 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. From Week 12 through Week 24
Secondary Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3 Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS. Week 24
Secondary Extension Period: Proportion of participants who achieve HiSCR 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 Week 54
Secondary Extension Period: Proportion of participants who achieve HiSCR75 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. Week 54
Secondary Extension Period : Proportion of participants with flare 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. From Week 12 through Week 54
Secondary Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score = 3. 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. Week 54
Secondary Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit 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. From Week 12 through Week 54
Secondary Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit 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. From Week 12 through Week 54
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