Hidradenitis Suppurativa (HS)Phase 2NCT07213973
Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing Povorcitinib in people with Hidradenitis Suppurativa (HS), run by Incyte Corporation at 30 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Povorcitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 2 Feb 2026to 25 Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- Agreement to use contraception.
- Willing and able to comply with the study protocol and procedures.
- Further inclusion criteria apply.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 2 countries
United States26 sites, 26 recruiting
- Recruiting
University of New Mexico Hospital
Albuquerque, New Mexico, 87102
- Recruiting
Oakland Hills Dermatology Pc
Auburn Hills, Michigan, 48326
- Recruiting
Johns Hopkins Univ Schl of Medicine
Baltimore, Maryland, 21205
- Recruiting
Bellaire Dermatology Associates Bda
Bellaire, Texas, 77401
- Recruiting
University of Alabama At Birmingham
Birmingham, Alabama, 35233
- Recruiting
Boston Childrens Hospital
Boston, Massachusetts, 02115
- Recruiting
Equity Medical
Bowling Green, Kentucky, 42104
- Recruiting
Texas Dermatology Research Center
Dallas, Texas, 75246
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
- Recruiting
Wayne State University Physician Group Dermatology
Detroit, Michigan, 48201
- Recruiting
3A Research Llc West Location
El Paso, Texas, 79902
- Recruiting
Uconn Health
Farmington, Connecticut, 06030
- Not yet recruiting
Skin Oasis Dermatology
Gambrills, Maryland, 21054
- Not yet recruiting
University of Missouri Kansas City
Kansas City, Missouri, 64108
- Recruiting
Dermatology Skin Cancer Center Leawood
Leawood, Kansas, 66211
- Recruiting
University of Miami Miller School of Medicine
Miami, Florida, 33136
- Recruiting
Skin Research of South Florida, Llc
Miami, Florida, 33173
- Recruiting
Boeson Research Missoula 2825 Fort Missoula Rd
Missoula, Montana, 59804
- Recruiting
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, 85006
- Recruiting
Saguaro Dermatology
Phoenix, Arizona, 85008
- Recruiting
Advanced Medical Research Pc
Sandy Springs, Georgia, 30328
- Recruiting
Endeavor Health Medical Group
Skokie, Illinois, 60077
- Recruiting
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
Trueblue Clinical Research
Tampa, Florida, 33607
- Recruiting
Revival Research Institute, Llc Troy
Troy, Michigan, 48084
Canada4 sites, 4 recruiting
- Recruiting
Dermcare Clinic
Mississauga, Ontario, L4W 0C2
- Recruiting
York Dermatology Center
Richmond Hill, Ontario, L4B 1L1
- Recruiting
Skincare Studio Dermatology Centre
St. John's, A1E 1V4
- Recruiting
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Povorcitinib
- Keywords
- Hidradenitis Suppurativa, HS, INCB054707, Povorcitinib, Acne inversa, Hidradenitis
- Medical subject headings
- Hidradenitis Suppurativa, Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovorcitinibDrug
Also called INCB054707
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| Povorcitinib Dose A | Experimental | Participants will receive povorcitinib dose A for 54 weeks. Receives: Drug: Povorcitinib |
| Povorcitinib Dose B | Experimental | Participants will receive povorcitinib dose B for 54 weeks. Receives: Drug: Povorcitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Week 54
Apparent clearance
Measured: Up to Week 24
Apparent volume of distribution
Measured: Up to Week 24
Apparent oral absorption rate constant
Measured: Up to Week 24
Absorption lag time
Measured: Up to Week 24
Maximum plasma drug concentration at steady state
Measured: Up to Week 24
Average plasma drug concentration at steady state
Measured: Up to Week 24
Plasma concentration at steady state for the dosing interval
Measured: Up to Week 24
Time to maximum plasma concentration at steady state
Measured: Up to Week 24
Terminal half-life
Measured: Up to Week 24
Secondary outcomes (11)
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.
Measured: 54 weeks
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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.
Measured: 54 weeks
Mean change from baseline in abscess count at each visit
Defined as mean change of abscess count relative to baseline.
Measured: 54 weeks
Mean percentage change from baseline in abscess count at each visit
Defined as mean percentage change from baseline in abscess count.
Measured: 54 weeks
Mean change from baseline in inflammatory nodule count at each visit
Defined as mean change of inflammatory nodule count relative to baseline.
Measured: 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.
Measured: 54 weeks
Mean change from baseline in draining tunnel count at each visit
Defined as mean change of draining tunnel count relative to baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start2 Feb 2026
- Primary completion25 Mar 2028 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213973
- Sponsor's protocol ID
- INCB054707-211
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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