A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov processed this data on November 15, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified November 2024 by Incyte Corporation
Sponsor
Incyte CorporationInformation Provided by (Responsible Party)
Incyte CorporationClinicaltrials.gov Identifier
NCT06212999Other Study ID Numbers: INCB 54707-312
First Submitted: January 9, 2024
First Posted: January 19, 2024
Last Update Posted: November 18, 2024
Last Verified: November 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 | 960 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| Primary Purpose | Treatment |
| Official Title | A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa |
| Study Start Date | January 30, 2024 |
| Anticipated Primary Completion Date | December 26, 2026 |
| Anticipated Study Completion Date | December 26, 2026 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) [up to approximately 56 weeks] TEAE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.
Secondary Outcome Measures
- Proportion of participants with Serious Treatment-Emergent Adverse Events (TEAEs) [up to approximately 56 weeks] Serious TEAE is defined as any untoward medical occurrence that, at any dose, meet at least one of the following criteria: (a) results in death; (b) is life-threatening; (c) requires inpatient hospitalization or prolongation of existing hospitalization; (d) results in persistent or significant disability/incapacity; (e) is a congenital anomaly/birth defect; (f) is an important medical event.
- Proportion of participants with TEAEs leading to study drug discontinuation [up to approximately 56 weeks] Defined as any TEAE that leads to discontinuation of study drug.
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [up to approximately 56 weeks] HiSCR is defined as at least a 50% reduction from baseline of parent study in the total abscess and inflammatory nodule (AN) count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [up to approximately 56 weeks] HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) [up to approximately 56 weeks] HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100) [up to approximately 56 weeks] HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants with flare at each visit [up to approximately 56 weeks] Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 ANs relative to Week 54.
- Time to first flare [up to approximately 56 weeks] Time to first flare during the long-term extension study.
- Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit [up to approximately 56 weeks] The HiSQoL is a HS-specific, health-related quality of life (QoL) instrument. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.
- Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit [up to approximately 56 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.
- Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit [up to approximately 56 weeks]
- Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit [up to approximately 56 weeks] ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
- Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit [up to approximately 56 weeks]
- Proportion of participants with a total AN count of 0, 1, or 2 at each visit [up to approximately 56 weeks] AN count defined as the total sum of abscesses and inflammatory nodules.
- Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit [up to approximately 56 weeks] ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.
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 |
| Inclusion Criteria |
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| Exclusion Criteria |
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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