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NCT Number: NCT07213973

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants 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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermcare Clinic, Mississauga, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

Oral; Tablet

Other names: INCB054707

Primary outcomes

  1. Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 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.

  2. Apparent clearance

    Time frame: Up to Week 24

  3. Apparent volume of distribution

    Time frame: Up to Week 24

  4. Apparent oral absorption rate constant

    Time frame: Up to Week 24

  5. Absorption lag time

    Time frame: Up to Week 24

  6. Maximum plasma drug concentration at steady state

    Time frame: Up to Week 24

  7. Average plasma drug concentration at steady state

    Time frame: Up to Week 24

  8. Plasma concentration at steady state for the dosing interval

    Time frame: Up to Week 24

  9. Time to maximum plasma concentration at steady state

    Time frame: Up to Week 24

  10. Terminal half-life

    Time frame: Up to Week 24

Secondary outcomes

  1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

    Time frame: 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.

  2. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

    Time frame: 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.

  3. Mean change from baseline in abscess count at each visit

    Time frame: 54 weeks

    Defined as mean change of abscess count relative to baseline.

  4. Mean percentage change from baseline in abscess count at each visit

    Time frame: 54 weeks

    Defined as mean percentage change from baseline in abscess count.

  5. Mean change from baseline in inflammatory nodule count at each visit

    Time frame: 54 weeks

    Defined as mean change of inflammatory nodule count relative to baseline.

  6. Mean percentage change from baseline in inflammatory nodule count at each visit

    Time frame: 54 weeks

    Defined as mean percentage change from baseline in inflammatory nodule count.

  7. Mean change from baseline in draining tunnel count at each visit

    Time frame: 54 weeks

    Defined as mean change of draining tunnel count relative to baseline.

  8. Mean percentage change from baseline in draining tunnel count at each visit

    Time frame: 54 weeks

    Defined as mean percentage change from baseline in draining tunnel count.

  9. Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3

    Time frame: 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.

  10. Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3

    Time frame: 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.

  11. Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 9, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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