Hidradenitis Suppurativa (HS)
Conditions
Keywords
Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis
Brief summary
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.
Interventions
DRUGPovorcitinib
Oral; Tablet
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 12 to \< 18 years at the time of informed consent/assent signing. * Body weight ≥ 30 kg at both screening and baseline visits. * Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit. * Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits. * HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits. * Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS). * Agreement to use contraception. * Willing and able to comply with the study protocol and procedures. * Further inclusion criteria apply.
Exclusion criteria
* Presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * Laboratory values outside of the protocol-defined ranges. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) | Baseline through Week 54 | TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. |
| Apparent clearance | Up to Week 24 | — |
| Apparent volume of distribution | Up to Week 24 | — |
| Apparent oral absorption rate constant | Up to Week 24 | — |
| Absorption lag time | Up to Week 24 | — |
| Maximum plasma drug concentration at steady state | Up to Week 24 | — |
| Average plasma drug concentration at steady state | Up to Week 24 | — |
| Plasma concentration at steady state for the dosing interval | Up to Week 24 | — |
| Time to maximum plasma concentration at steady state | Up to Week 24 | — |
| Terminal half-life | Up to Week 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | 54 weeks | HiSCR50 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. |
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | 54 weeks | 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. |
| Mean change from baseline in abscess count at each visit | 54 weeks | Defined as mean change of abscess count relative to baseline. |
| Mean percentage change from baseline in abscess count at each visit | 54 weeks | Defined as mean percentage change from baseline in abscess count. |
| Mean change from baseline in inflammatory nodule count at each visit | 54 weeks | Defined as mean change of inflammatory nodule count relative to baseline. |
| Mean percentage change from baseline in inflammatory nodule count at each visit | 54 weeks | Defined as mean percentage change from baseline in inflammatory nodule count. |
| Mean change from baseline in draining tunnel count at each visit | 54 weeks | Defined as mean change of draining tunnel count relative to baseline. |
| Mean percentage change from baseline in draining tunnel count at each visit | 54 weeks | Defined as mean percentage change from baseline in draining tunnel count. |
| Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3 | 54 weeks | Defined as participants with a Skin Pain NRS score of at least 3 at baseline and who achieve 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 ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3 | 54 weeks | 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. |
| Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit | 54 weeks | The CDLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days, across symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. |
Countries
Canada, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed