A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov processed this data on October 3, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified October 2024 by Incyte Corporation
Sponsor
Incyte CorporationInformation Provided by (Responsible Party)
Incyte CorporationClinicaltrials.gov Identifier
NCT05620823Other Study ID Numbers: INCB 54707-301
First Submitted: November 10, 2022
First Posted: November 17, 2022
Last Update Posted: October 4, 2024
Last Verified: October 2024
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
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Study Design
| Study Type | Interventional |
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| Anticipated Enrollment | 600 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | December 19, 2022 |
| Anticipated Primary Completion Date | March 11, 2025 |
| Anticipated Study Completion Date | January 30, 2026 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 who achieve HiSCR [Week 54] 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 54] 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 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.
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
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Contacts and Locations
| Sponsors and Collaborators | Incyte Corporation |
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More Information
Additional Relevant MeSH Terms
- Hidradenitis Suppurativa
- Hidradenitis
- Sweat Gland Diseases
- Skin Diseases
- Skin Diseases, Bacterial
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
- Skin Diseases, Infectious
- Suppuration