Povorcitinib for adolescents with moderate to severe hidradenitis suppurativa
A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
PHASE2 · Incyte Corporation · NCT07213973
This trial tests the oral drug povorcitinib in adolescents aged 12–17 with moderate to severe hidradenitis suppurativa to see if it is safe, how the body handles it, and whether it reduces lesions over a 54-week treatment period.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Incyte Corporation (industry) |
| Drugs / interventions | povorcitinib |
| Locations | 27 sites (Birmingham, Alabama and 26 other locations) |
| Trial ID | NCT07213973 on ClinicalTrials.gov |
What this trial studies
This Phase 2 open-label trial gives adolescents with moderate to severe hidradenitis suppurativa oral povorcitinib for up to 54 weeks to measure pharmacokinetics, safety, and clinical response. Eligible participants are 12–17 years old, weigh at least 30 kg, have at least five abscesses or inflammatory nodules and meet refined Hurley stages IB–III, and must have a history of inadequate response or intolerance to prior systemic therapy. The protocol involves regular clinic visits for lesion counts, laboratory monitoring, and adverse event reporting at participating sites. There is no placebo arm and dosing and monitoring follow the trial protocol.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12–17 years, weighing at least 30 kg, with moderate to severe HS (≥5 abscesses/inflammatory nodules and refined Hurley stages IB–III) who have had an inadequate response or intolerance to at least one conventional systemic therapy.
Not a fit: Patients with very advanced disease who have more than 20 draining tunnels, children younger than 12 or adults 18 and older, or those weighing less than 30 kg are not eligible and therefore would not receive benefit from participating in this protocol.
Why it matters
Potential benefit: If successful, povorcitinib could provide an effective oral option to reduce lesions and symptoms in adolescents with moderate to severe HS.
How similar studies have performed: Adult trials of JAK1 inhibitors, including earlier studies of povorcitinib, have shown promising efficacy and safety signals in HS, but pediatric data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 exclusion criteria apply.
Where this trial is running
Birmingham, Alabama and 26 other locations
- University of Alabama At Birmingham — Birmingham, Alabama, United States (NOT_YET_RECRUITING)
- Medical Dermatology Specialists Phoenix — Phoenix, Arizona, United States (RECRUITING)
- Saguaro Dermatology — Phoenix, Arizona, United States (RECRUITING)
- Uconn Health — Farmington, Connecticut, United States (NOT_YET_RECRUITING)
- University of Miami Miller School of Medicine — Miami, Florida, United States (RECRUITING)
- Skin Research of South Florida, Llc — Miami, Florida, United States (RECRUITING)
- Trueblue Clinical Research — Tampa, Florida, United States (RECRUITING)
- Advanced Medical Research Pc — Sandy Springs, Georgia, United States (RECRUITING)
- Endeavor Health Medical Group — Skokie, Illinois, United States (RECRUITING)
- Dermatology Skin Cancer Center Leawood — Leawood, Kansas, United States (RECRUITING)
- Equity Medical — Bowling Green, Kentucky, United States (RECRUITING)
- Johns Hopkins Oncology Center — Baltimore, Maryland, United States (RECRUITING)
- Boston Childrens Hospital — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Oakland Hills Dermatology Pc — Auburn Hills, Michigan, United States (RECRUITING)
- Wayne State University Physician Group Dermatology — Detroit, Michigan, United States (RECRUITING)
- Revival Research Institute, Llc Troy — Troy, Michigan, United States (RECRUITING)
- Washington University — St Louis, Missouri, United States (RECRUITING)
- Boeson Research Missoula 2825 Fort Missoula Rd — Missoula, Montana, United States (RECRUITING)
- University of New Mexico Hospital — Albuquerque, New Mexico, United States (RECRUITING)
- Geisinger Medical Center — Danville, Pennsylvania, United States (NOT_YET_RECRUITING)
- Bellaire Dermatology Associates Bda — Bellaire, Texas, United States (RECRUITING)
- Texas Dermatology Research Center — Dallas, Texas, United States (RECRUITING)
- Jordan Valley Dermatology Center — South Jordan, Utah, United States (RECRUITING)
- Dermcare Clinic — Mississauga, Ontario, Canada (RECRUITING)
- York Dermatology Center — Richmond Hill, Ontario, Canada (RECRUITING)
- The Hospital For Sick Children — Toronto, Ontario, Canada (RECRUITING)
- Skincare Studio Dermatology Centre — St. John's, Canada (RECRUITING)
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis