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A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS1)

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ClinicalTrials.gov Identifier: NCT05620823
Recruitment Status : Recruiting
First Posted : November 17, 2022
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa (HS) Drug: Povorcitinib Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date : December 19, 2022
Estimated Primary Completion Date : March 11, 2025
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 54 weeks.
 Drug: Povorcitinib
Oral; Tablet
Other Name: INCB054707
Experimental: Povorcitinib Dose B
Participants will receive Povorcitinib Dose B for 54 weeks.
 Drug: Povorcitinib
Oral; Tablet
Other Name: INCB054707
Placebo Comparator: Placebo
Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
 Drug: Placebo
Oral; Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 12 ]
    HiSCR 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.


Secondary Outcome Measures :
  1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [ Time Frame: Week 12 ]
    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.

  2. Proportion of participants with flare [ Time Frame: 12 weeks ]
    Participants who experience at least 1 flare over 12 weeks; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.

  3. Proportion of participants with a ≥ 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score ≥ 3. [ Time Frame: Week 12 ]
    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 at Week 12, relative to baseline. Skin Pain is an 11 point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).

  4. Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. [ Time Frame: Week 12 ]
    Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 12 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

  5. Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score [ Time Frame: Week 12 ]
    Participants with a baseline FACIT-F score ≤ 48 and who experience at least a 4-point increase in FACIT-F score at Week 12, relative to baseline. The FACIT-F scale is a 13-item questionnaire that assesses self reported fatigue and its impact upon daily activities and function over the past 7 days, with scores ranging from 0 (worst fatigue) to 52 (no fatigue).

  6. Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit [ Time Frame: 54 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.

  7. Mean change from baseline in abscess count at each visit. [ Time Frame: 54 weeks ]
    Defined as mean change of Abscess count relative to baseline.

  8. Percentage change from baseline in abscess count at every visit [ Time Frame: 54 weeks ]
    Percent change from baseline in number of abscess(es)

  9. 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.

  10. Percentage change from baseline in inflammatory nodule count at each visit. [ Time Frame: 54 weeks ]
    Defined as percent change from baseline in number of inflammatory nodule(s)

  11. 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.

  12. Percentage change from baseline in draining tunnel count at each visit. [ Time Frame: 54 weeks ]
    Defined as percent change from baseline in number of draining tunnel(s)

  13. Extension Period: Proportion of participants who achieve HiSCR [ Time Frame: Week 24 ]
    HiSCR 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.

  14. Extension Period: Proportion of participants who achieve HiSCR75 [ Time Frame: Week 24 ]
    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.

  15. Extension Period: Proportion of participants with flare [ Time Frame: From Week 12 through Week 24 ]
    Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.

  16. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3 [ Time Frame: Week 24 ]
    Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

  17. Extension Period: Proportion of participants who achieve HiSCR [ Time Frame: Week 54 ]
    HiSCR 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

  18. Extension Period: Proportion of participants who achieve HiSCR75 [ Time Frame: Week 54 ]
    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.

  19. Extension Period : Proportion of participants with flare [ Time Frame: From Week 12 through Week 54 ]
    Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.

  20. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. [ Time Frame: Week 54 ]
    Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 24 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

  21. Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit [ Time Frame: From Week 12 through Week 54 ]
    Maintenance of response defined as participants who achieve HiSCR at Week 12 and maintain it or achieve greater response at each visit during the EXT period.

  22. Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit [ Time Frame: From Week 12 through Week 54 ]
    Maintenance of response defined as participants who achieve HiSCR75 at Week 12 and maintain it or achieve greater response at each visit during the EXT period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage 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 NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.
  • Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05620823


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT05620823    
Other Study ID Numbers: INCB 54707-301
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: 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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Hidradenitis Suppurativa
Hidradenitis
Acne inversa
 HS
INCB054707
Povorcitinib
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration