Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, Hidradenitis, Acne inversa, HS, Povorcitinib, Long-Term Extension (LTE), INCB054707
Brief summary
The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).
Interventions
DRUGPovorcitinib
Oral; Tablet
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Cohort C is open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302). * Agreement to use contraception. * Willing and able to comply with the study protocol and procedures. * Further inclusion criteria apply.
Exclusion criteria
* Participation in the extension study could expose the participant to an undue safety risk. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed