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NCT Number: NCT06212999

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

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]).

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This study is active but is not currently recruiting participants.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site AU203, Charlestown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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: 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 outcomes

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

    Time frame: 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.

  2. Proportion of participants with TEAEs leading to study drug discontinuation

    Time frame: up to approximately 56 weeks

    Defined as any TEAE that leads to discontinuation of study drug.

  3. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)

    Time frame: 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.

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

    Time frame: 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.

  5. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)

    Time frame: 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.

  6. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 100 (HiSCR100)

    Time frame: 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.

  7. Proportion of participants with flare at each visit

    Time frame: 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.

  8. Time to first flare

    Time frame: up to approximately 56 weeks

    Time to first flare during the long-term extension study.

  9. Mean change from baseline of parent study in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each visit

    Time frame: 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.

  10. Mean change from baseline of parent study in Dermatology Life Quality Index (DLQI) score at each visit

    Time frame: 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.

  11. Proportion of participants with no increase in abscess and inflammatory nodule (AN) count relative to Week 54 at each visit

    Time frame: up to approximately 56 weeks

  12. Proportion of participants with no increase in abscess, inflammatory nodule, and draining tunnel (ANdT) count relative to Week 54 at each visit

    Time frame: up to approximately 56 weeks

    ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.

  13. Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit

    Time frame: up to approximately 56 weeks

  14. Proportion of participants with a total AN count of 0, 1, or 2 at each visit

    Time frame: up to approximately 56 weeks

    AN count defined as the total sum of abscesses and inflammatory nodules.

  15. Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit

    Time frame: up to approximately 56 weeks

    ANdT count is defined as the total sum of abscesses, inflammatory nodules, and draining tunnels.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 3, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

Acronym: STOP-HS LTE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Mar 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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