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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povorcitinib Dose A | Experimental | Participants will receive povorcitinib dose A for 54 weeks. |
|
| Povorcitinib Dose B | Experimental | Participants will receive povorcitinib dose B for 54 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povorcitinib | Drug | Oral; Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) | 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. | Baseline through Week 54 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | 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. | 54 weeks |
| Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham | Not yet recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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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. |
| 54 weeks |
| Mean change from baseline in abscess count at each visit | Defined as mean change of abscess count relative to baseline. | 54 weeks |
| Mean percentage change from baseline in abscess count at each visit | Defined as mean percentage change from baseline in abscess count. | 54 weeks |
| Mean change from baseline in inflammatory nodule count at each visit | Defined as mean change of inflammatory nodule count relative to baseline. | 54 weeks |
| Mean percentage change from baseline in inflammatory nodule count at each visit | Defined as mean percentage change from baseline in inflammatory nodule count. | 54 weeks |
| Mean change from baseline in draining tunnel count at each visit | Defined as mean change of draining tunnel count relative to baseline. | 54 weeks |
| Mean percentage change from baseline in draining tunnel count at each visit | Defined as mean percentage change from baseline in draining tunnel count. | 54 weeks |
| Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3 | 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. | 54 weeks |
| Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3 | 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. | 54 weeks |
| Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit | 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. | 54 weeks |
| Medical Dermatology Specialists Phoenix |
| Recruiting |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Saguaro Dermatology | Recruiting | Phoenix | Arizona | 85008 | United States |
| Uconn Health | Recruiting | Farmington | Connecticut | 06030 | United States |
| University of Miami Miller School of Medicine | Recruiting | Miami | Florida | 33136 | United States |
| Skin Research of South Florida, Llc | Recruiting | Miami | Florida | 33173 | United States |
| Trueblue Clinical Research | Recruiting | Tampa | Florida | 33607 | United States |
| Advanced Medical Research Pc | Recruiting | Sandy Springs | Georgia | 30328 | United States |
| Endeavor Health Medical Group | Recruiting | Skokie | Illinois | 60077 | United States |
| Dermatology Skin Cancer Center Leawood | Recruiting | Leawood | Kansas | 66211 | United States |
| Equity Medical | Recruiting | Bowling Green | Kentucky | 42104 | United States |
| Johns Hopkins Univ Schl of Medicine | Recruiting | Baltimore | Maryland | 21205 | United States |
| Skin Oasis Dermatology | Not yet recruiting | Gambrills | Maryland | 21054 | United States |
| Boston Childrens Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
| Oakland Hills Dermatology Pc | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| Wayne State University Physician Group Dermatology | Recruiting | Detroit | Michigan | 48201 | United States |
| Revival Research Institute, Llc Troy | Recruiting | Troy | Michigan | 48084 | United States |
| University of Missouri Kansas City | Not yet recruiting | Kansas City | Missouri | 64108 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| Boeson Research Missoula 2825 Fort Missoula Rd | Recruiting | Missoula | Montana | 59804 | United States |
| University of New Mexico Hospital | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Geisinger Medical Center | Not yet recruiting | Danville | Pennsylvania | 17822 | United States |
| Bellaire Dermatology Associates Bda | Recruiting | Bellaire | Texas | 77401 | United States |
| Texas Dermatology Research Center | Recruiting | Dallas | Texas | 75246 | United States |
| 3A Research Llc West Location | Not yet recruiting | El Paso | Texas | 79902 | United States |
| Jordan Valley Dermatology Center | Recruiting | South Jordan | Utah | 84095 | United States |
| Dermcare Clinic | Recruiting | Mississauga | Ontario | L4W 0C2 | Canada |
| York Dermatology Center | Recruiting | Richmond Hill | Ontario | L4B 1L1 | Canada |
| The Hospital For Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| Skincare Studio Dermatology Centre | Recruiting | St. John's | A1E 1V4 | Canada |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D016575 | Hidradenitis |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013543 | Sweat Gland Diseases |
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