A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
- Registration Number
- NCT06212999
- Lead Sponsor
- Incyte Corporation
- 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 \[NCT05620836\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 960
- 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.
- 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 exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Povorcitinib Povorcitinib at the protocol-defined dose strength based on cohort assignment. Cohort B Povorcitinib Povorcitinib at the protocol-defined dose strength based on cohort assignment. Cohort C Povorcitinib Povorcitinib at the protocol-defined dose strength based on cohort assignment.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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.
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.
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.
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 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.
Time to first flare up to approximately 56 weeks Time to first flare during the long-term extension study.
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 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.
Trial Locations
- Locations (172)
Investigative Site US303
🇺🇸Phoenix, Arizona, United States
Investigative Site US240
🇺🇸Scottsdale, Arizona, United States
Investigative Site US307
🇺🇸Fort Smith, Arkansas, United States
Investigative Site US214
🇺🇸Rogers, Arkansas, United States
Investigative Site US315
🇺🇸Laguna Niguel, California, United States
Investigative Site US223
🇺🇸Los Angeles, California, United States
Investigative Site US222
🇺🇸Oakland, California, United States
Investigative Site US226
🇺🇸San Diego, California, United States
Investigative Site US233
🇺🇸Washington, District of Columbia, United States
Investigative Site US309
🇺🇸Clearwater, Florida, United States
Scroll for more (162 remaining)Investigative Site US303🇺🇸Phoenix, Arizona, United States