AzTrials
AzTrials

Hidradenitis Suppurativa (HS)Phase 3STOP-HS2NCT05620836

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

A Phase 3 study testing Povorcitinib in people with Hidradenitis Suppurativa (HS), run by Incyte Corporation at 101 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
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?
Yes, some participants may receive a placebo
How many people
619 participants
Where
101 sitesin 11 countries
Study dates
22 Feb 2023to 21 Nov 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants ≥ 18 years of age.
  • Diagnosis of moderate to severe HS ≥ 3 months prior to Screening visit.
  • HS lesions present in ≥ 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the Screening and Baseline visits.
  • Total abscess and inflammatory nodule (AN) count ≥ 5 at both the Screening and Baseline visits.
  • History of inadequate response to an appropriate course of at least 1 conventional systemic therapy for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for HS)
  • Agree to not use certain topical antiseptics on the areas affected by HS lesions during the placebo-controlled period.
  • Willingness to avoid pregnancy or fathering children.
  • Other inclusion criteria apply.

Who cannot join

  • Draining tunnel count of > 20 at Screening or Baseline visits.
  • Women who are pregnant (or who are considering pregnancy) or breastfeeding.
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
  • Evidence of infection with TB, HBV, HCV or HIV.
  • History of failure to JAK inhibitor treatment of any inflammatory disease.
  • Laboratory values outside of the protocol-defined ranges.
  • Other exclusion criteria apply.

Trial locations and contacts

101 sites in 11 countries.

101 sites in 11 countries

United States38 sites

  • Investigative Site US214

    Arkansas City, Arkansas, 72758

  • Investigative Site US235

    Arlington, Texas, 76011

  • Investigative Site US224

    Baltimore, Maryland, 21224

  • Investigative Site US218

    Bellaire, Texas, 77401

  • Investigative Site US208

    Beverly, Massachusetts, 01915

  • Investigative Site US215

    Bexley, Ohio, 43209

  • Investigative Site US228

    Brandon, Florida, 33511

  • Investigative Site US205

    Chapel Hill, North Carolina, 27516

  • Investigative Site US203

    Columbus, Ohio, 43210

  • Investigative Site US213

    Detroit, Michigan, 48084

  • Investigative Site US242

    Fayetteville, Arkansas, 72703

  • Investigative Site US230

    Hightstown, New Jersey, 08520

  • Investigative Site US206

    Indianapolis, Indiana, 46250

  • Investigative Site US241

    Iowa City, Iowa, 52242

  • Investigative Site US223

    Los Angeles, California, 90033

  • Investigative Site US209

    Louisville, Kentucky, 40241

  • Investigative Site US227

    Margate, Florida, 33063

  • Investigative Site US207

    Metairie, Louisiana, 70006

  • Investigative Site US204

    Miami, Florida, 33125

  • Investigative Site US236

    Miami, Florida, 33173

  • Investigative Site US212

    Minneapolis, Minnesota, 55455

  • Investigative Site US232

    Murfreesboro, Tennessee, 37130

  • Investigative Site US229

    New Orleans, Louisiana, 70115

  • Investigative Site US202

    New York, New York, 10003

  • Investigative Site US200

    Ocala, Florida, 34470

  • Investigative Site US239

    Omaha, Nebraska, 68144

  • Investigative Site US238

    Pflugerville, Texas, 78660

  • Investigative Site US221

    Quincy, Massachusetts, 02169

  • Investigative Site US210

    Rochester, New York, 14642

  • Investigative Site US234

    San Antonio, Texas, 78213

  • Investigative Site US226

    San Diego, California, 92103

  • Investigative Site US222

    San Francisco, California, 94118

  • Investigative Site US240

    Scottsdale, Arizona, 85255

  • Investigative Site US237

    Scottsdale, Arizona, 85259

  • Investigative Site US201

    Tampa, Florida, 33613

  • Investigative Site US233

    Washington D.C., District of Columbia, 20060

  • Investigative Site US217

    Waterford, Michigan, 48328

  • Investigative Site US220

    West Dundee, Illinois, 60118

Other trials in United States

Germany10 sites

  • Investigative Site DE202

    Berlin, 10117

  • Investigative Site DE203

    Bochum, 44791

  • Investigative Site DE201

    Dessau, 06847

  • Investigative Site DE207

    Erlangen, 91054

  • Investigative Site US225

    Frankfurt am Main, MA, 60590

  • Investigative Site DE208

    Göttingen, 37075

  • Investigative Site DE205

    Heidelberg, 69120

  • Investigative Site DE200

    Kiel, 24105

  • Investigative Site DE204

    Lübeck, 23538

  • Investigative Site DE206

    Mainz, 55131

Other trials in Germany

Australia8 sites

  • Investigative Site AU202

    Benowa, Queensland, 04217

  • Investigative Site AU201

    Carlton, Victoria, 03053

  • Investigative Site AU205

    Kogarah, New South Wales, 02217

  • Investigative Site AU203

    Kotara, New South Wales, 02289

  • Investigative Site AU200

    Liverpool, New South Wales, 02170

  • Investigative Site AU204

    Melbourne, Victoria, 03002

  • Investigative Site AU206

    Woolloongabba, Queensland, 04102

  • Investigative Site AU207

    Woolloongabba, Queensland, 04102

Other trials in Australia

Canada8 sites

  • Investigative Site CA202

    Calgary, Alberta, T3E 0B2

  • Investigative Site CA204

    Edmonton, Alberta, T6G 1C3

  • Investigative Site CA205

    Fredericton, New Brunswick, E3B 1G9

  • Investigative Site CA207

    Mississauga, Ontario, L4W 0C2

  • Investigative Site CA208

    Richmond Hill, Ontario, L4C 9M7

  • Investigative Site CA206

    Saint-Jérôme, Quebec, J7Z 7E2

  • Investigative Site CA203

    St. John's, A1A 4Y3

  • Investigative Site CA200

    Surrey, British Columbia, V3V 0C6

Other trials in Canada

Italy8 sites

  • Investigative Site IT200

    Ancona, 60126

  • Investigative Site IT204

    Brescia, 25124

  • Investigative Site IT207

    Catania, 95123

  • Investigative Site IT202

    Milan, 20122

  • Investigative Site IT203

    Naples, 80131

  • Investigative Site IT206

    Pisa, 56126

  • Investigative Site IT205

    Roma, 00168

  • Investigative Site IT201

    Rozzano, 20089

Other trials in Italy

France7 sites

  • Investigative Site FR200

    Antony, 92160

  • Investigative Site FR205

    Dijon, 21000

  • Investigative Site FR204

    Lyon, 69003

  • Investigative Site FR203

    Nice, 06200

  • Investigative Site FR206

    Reims, 51100

  • Investigative Site FR202

    Rouen, 76031

  • Investigative Site FR201

    Toulon, 83000

Other trials in France

Spain6 sites

  • Investigative Site ES203

    Alicante, 03010

  • Investigative Site ES202

    Las Palmas de Gran Canaria, 35019

  • Investigative Site ES204

    Madrid, 28005

  • Investigative Site ES201

    Madrid, 28007

  • Investigative Site ES205

    Madrid, 28040

  • Investigative Site ES200

    Manises, 46940

Other trials in Spain

Bulgaria5 sites

  • Investigative Site BG203

    Sofia, 01407

  • Investigative Site BG202

    Sofia, 01463

  • Investigative Site BG200

    Sofia, 01510

  • Investigative Site BG204

    Sofia, 01606

  • Investigative Site BG201

    Stara Zagora, 06000

Other trials in Bulgaria

United Kingdom5 sites

  • Investigative Site GB202

    Birmingham, B15 2GW

  • Investigative Site GB200

    Dudley, DY1 2HQ

  • Investigative Site GB201

    Leeds, LS1 3EX

  • Investigative Site GB204

    London, SE1 7EH

  • Investigative Site GB203

    Salford, M6 8HD

Other trials in United Kingdom

Poland4 sites

  • Investigative Site PL203

    Lublin, 20573

  • Investigative Site PL200

    Rzeszów, 35-055

  • Investigative Site PL201

    Warsaw, 02-507

  • Investigative Site PL202

    Warsaw, 02-962

Other trials in Poland

Denmark2 sites

  • Investigative Site DK200

    Århus N, 08200

  • Investigative Site DK201

    Roskilde, 04000

Other trials in Denmark

About this study

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

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.

Being tested
Povorcitinib, Placebo
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

  • PlaceboDrug

    Oral, Tablet

Study groups in NCT05620836
Study groupRoleWhat they receive
Povorcitinib Dose AExperimentalParticipants will receive Povorcitinib Dose A for 54 weeks.
Receives: Drug: Povorcitinib
Povorcitinib Dose BExperimentalParticipants will receive Povorcitinib Dose B for 54 weeks.
Receives: Drug: Povorcitinib
PlaceboPlacebo comparatorParticipants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 12

    HiSCR50 is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 12

Secondary outcomes (43)

  1. Percentage of Participants Who Achieved HiSCR75 at Week 12

    HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 12

  2. Percentage of Participants With Flare by Week 12

    Participants who experienced at least 1 flare over 12 weeks were assessed. Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 relative to baseline.

    Measured: Baseline; Week 12

  3. Percentage of Participants With at Least a 3-point Decrease in Skin Pain Numerical Rating Scale (NRS) Score at Week 12 Among Participants With a Baseline Skin Pain NRS Score ≥3

    Participants with a Skin Pain score of at least 3 at baseline and who experienced at least a 3-point decrease in Skin Pain score at Week 12, relative to baseline, were assessed. Skin Pain was assessed using an 11-point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).

    Measured: Baseline; Week 12

  4. Percentage of Participants Who Achieved Skin Pain NRS30 at Week 12 Among Participants With a Baseline Skin Pain NRS Score of at Least 3

    Participants with a Skin Pain score of at least 3 at baseline and who achieved Skin Pain NRS30 at Week 12, defined as at least a 30% reduction and at least a 1-unit reduction from baseline in the Skin Pain NRS, were assessed. Skin Pain was assessed using an 11-point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain). analyzed.

    Measured: Baseline; Week 12

  5. Percentage of Participants With at Least a 4-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 12

    Participants with a baseline FACIT-F score ≤48 and who experienced at least a 4-point increase in FACIT-F score at Week 12, relative to baseline, were assessed. 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 for each item ranging from 0 (worst fatigue) to 4 (no fatigue). The total score is a sum of the 13 item scores and ranges from 0 (worst fatigue) to 52 (no fatigue).

    Measured: Baseline; Week 12

  6. Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    The DLQI is a 10-question, validated questionnaire that measures how much the skin problem has affected the participant over the previous 7 days, across symptoms and feelings, daily activities, leisure, work and school, personal relations, and treatment. Each question is scored as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. Change from baseline was calculated as the post-baseline value minus the baseline value. Scores from each question are summed to produce a total score, ranging from 0 (not relevant) to 30 (very much). A higher score reflects a greater negative impact on quality of life.

    Measured: Baseline; up to Week 54

  7. Mean Change From Baseline in DLQI Score at Each Visit During the Extension Period

    The DLQI is a 10-question, validated questionnaire that measures how much the skin problem has affected the participant over the previous 7 days, across symptoms and feelings, daily activities, leisure, work and school, personal relations, and treatment. Each question is scored as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. Change from baseline was calculated as the post-baseline value minus the baseline value. Scores from each question are summed to produce a total score, ranging from 0 (not relevant) to 30 (very much). A higher score reflects a greater negative impact on quality of life.

    Measured: Baseline; up to Week 54

  8. Mean Change From Baseline in Abscess Count at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; up to Week 54

  9. Mean Change From Baseline in Abscess Count at Each Visit During the Extension Period

    Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; up to Week 54

  10. Percentage Change From Baseline (PCFB) in Abscess Count at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    Percentage change from baseline was calculated as (post-baseline value minus the baseline value) divided by the baseline value x 100.

    Measured: Baseline; up to Week 54

  11. Percentage Change From Baseline in Abscess Count at Each Visit During the Extension Period

    Percentage change from baseline was calculated as (post-baseline value minus the baseline value) divided by the baseline value x 100.

    Measured: Baseline; up to Week 54

  12. Mean Change From Baseline in Inflammatory Nodule Count at Each Visit at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; up to Week 54

  13. Mean Change From Baseline in Inflammatory Nodule Count at Each Visit During the Extension Period

    Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; up to Week 54

  14. Percentage Change From Baseline in Inflammatory Nodule Count at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    Percentage change from baseline was calculated as (post-baseline value minus the baseline value) divided by the baseline value x 100.

    Measured: Baseline; up to Week 54

  15. Percentage Change From Baseline in Inflammatory Nodule Count at Each Visit During the Extension Period

    Percentage change from baseline was calculated as (post-baseline value minus the baseline value) divided by the baseline value x 100.

    Measured: Baseline; up to Week 54

  16. Mean Change From Baseline in Draining Tunnel Count at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; up to Week 54

  17. Mean Change From Baseline in Draining Tunnel Count at Each Visit During the Extension Period

    Change from baseline was calculated as the post-baseline value minus the baseline value.

    Measured: Baseline; up to Week 54

  18. Percentage Change From Baseline in Draining Tunnel Count at Each Visit During the Placebo-controlled Period and the Overall Study (for Participants Who Took Only Povorcitinib)

    Percentage change from baseline was calculated as (post-baseline value minus the baseline value) divided by the baseline value x 100.

    Measured: Baseline; up to Week 54

  19. Percentage Change From Baseline in Draining Tunnel Count at Each Visit During the Extension Period

    Percentage change from baseline was calculated as (post-baseline value minus the baseline value) divided by the baseline value x 100.

    Measured: Baseline; up to Week 54

  20. Percentage of Participants Who Achieved HiSCR50 at Week 24 for Participants Who Took Only Povorcitinib

    HiSCR50 is defined as at least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 24

  21. Percentage of Participants Who Achieved HiSCR50 at Week 24 During the Extension Period

    HiSCR50 is defined as at least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 24

  22. Percentage of Participants Who Achieved HiSCR75 at Week 24 for Participants Who Took Only Povorcitinib

    HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 24

  23. Percentage of Participants Who Achieved HiSCR75 at Week 24 During the Extension Period

    HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 24

  24. Percentage of Participants With Flare by Week 24 for Participants Who Took Only Povorcitinib

    Participants who experienced at least 1 flare over 24 weeks were assessed. Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 relative to baseline.

    Measured: Baseline; up to Week 24

  25. Percentage of Participants With Flare by Week 24 During the Extension Period

    Participants who experienced at least 1 flare over 24 weeks were assessed. Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 relative to baseline.

    Measured: Baseline; up to Week 24

  26. Percentage of Participants Who Achieved Skin Pain NRS30 at Week 24 Among Participants With Baseline Skin Pain NRS Score of at Least 3 and Who Took Only Povorcitinib

    Participants with a Skin Pain score of at least 3 at baseline and who achieved Skin Pain NRS30 at Week 24, defined as at least a 30% reduction and at least a 1-unit reduction from baseline in the Skin Pain NRS, were assessed.

    Measured: Baseline; Week 24

  27. Percentage of Participants Who Achieved Skin Pain NRS30 at Week 24 During the Extension Period Among Participants With Baseline Skin Pain NRS Score of at Least 3

    Participants with a Skin Pain score of at least 3 at baseline and who achieved Skin Pain NRS30 at Week 24, defined as at least a 30% reduction and at least a 1-unit reduction from baseline in the Skin Pain NRS, were assessed.

    Measured: Baseline; Week 24

  28. Percentage of Participants Who Achieved HiSCR50 at Week 54 for Participants Who Took Only Povorcitinib

    HiSCR50 is defined as at least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 54

  29. Percentage of Participants Who Achieved HiSCR50 at Week 54 During the Extension Period

    HiSCR50 is defined as at least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 54

  30. Percentage of Participants Who Achieved HiSCR75 at Week 54 for Participants Who Took Only Povorcitinib

    HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 54

  31. Percentage of Participants Who Achieved HiSCR75 at Week 54 During the Extension Period

    HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: Baseline; Week 54

  32. Percentage of Participants With Flare by Week 54 for Participants Who Took Only Povorcitinib

    Participants who experienced at least 1 flare over 54 weeks were assessed. Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 relative to baseline.

    Measured: Baseline; up to Week 54

  33. Percentage of Participants With Flare at Week 54 During the Extension Period

    Participants who experienced at least 1 flare over 54 weeks were assessed. Flare is defined as at least a 25% increase in the total AN count with a minimum increase of 2 relative to baseline.

    Measured: Baseline; up to Week 54

  34. Percentage of Participants Who Achieved Skin Pain NRS30 at Week 54 Among Participants With Baseline Skin Pain NRS Score of at Least 3 and Who Took Only Povorcitinib

    Participants with a Skin Pain score of at least 3 at baseline and who achieved Skin Pain NRS30 at Week 54, defined as at least a 30% reduction and at least a 1-unit reduction from baseline in the Skin Pain NRS, were assessed.

    Measured: Baseline; Week 54

  35. Percentage of Participants Who Achieved Skin Pain NRS30 at Week 54 During the Extension Period Among Participants With Baseline Skin Pain NRS Score of at Least 3

    Participants with a Skin Pain score of at least 3 at baseline and who achieved Skin Pain NRS30 at Week 54, defined as at least a 30% reduction and at least a 1-unit reduction from baseline in the Skin Pain NRS, were assessed.

    Measured: Baseline; Week 54

  36. Percentage of Participants Who Achieved Maintenance of HiSCR50 or Greater Response During the Extension Period for Participants Who Took Only Povorcitinib

    Maintenance of response is defined as achieving HiSCR50 at Week 12 and maintaining it or achieving greater response at each visit during the extension period. HiSCR50 is defined as at least a 50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: up to 42 weeks (from end of Week 12 to end of Week 54)

  37. Percentage of Participants Who Achieved Maintenance of HiSCR75 or Greater Response During the Extension Period for Participants Who Took Only Povorcitinib

    Maintenance of response is defined as achieving HiSCR75 at Week 12 and maintaining it or achieving greater response at each visit during the extension period. HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count.

    Measured: up to 42 weeks (from end of Week 12 to end of Week 54)

  38. Placebo-controlled Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is 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. A TEAE is any AE, either reported for the first time or the worsening of a pre-existing event, occurring after the first dose of study drug until 30 days after the last dose of study drug.

    Measured: up to Week 16

  39. Placebo-controlled Period: Number of Participants With ≥Grade 3 TEAEs

    A TEAE is any AE, either reported for the first time or the worsening of a pre-existing event, occurring after the first dose of study drug until 30 days after the last dose of study drug. Severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

    Measured: up to Week 16

  40. Extension Period: Number of Participants With TEAEs

    An AE is 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. A TEAE is any AE, either reported for the first time or the worsening of a pre-existing event, occurring after the first dose of study drug until 30 days after the last dose of study drug.

    Measured: up to 46 weeks (from end of Week 12 to end of Week 58)

  41. Extension Period: Number of Participants With ≥Grade 3 TEAEs

    A TEAE is any AE, either reported for the first time or the worsening of a pre-existing event, occurring after the first dose of study drug until 30 days after the last dose of study drug. Severity of AEs was graded using the National Cancer Institute CTCAE version 5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

    Measured: up to 46 weeks (from end of Week 12 to end of Week 58)

  42. Overall Study Period: Number of Participants Who Took Only Povorcitinib With TEAEs

    An AE is 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. A TEAE is any AE, either reported for the first time or the worsening of a pre-existing event, occurring after the first dose of study drug until 30 days after the last dose of study drug.

    Measured: up to Week 58

  43. Overall Study Period: Number of Participants Who Took Only Povorcitinib With ≥Grade 3 TEAEs

    A TEAE is any AE, either reported for the first time or the worsening of a pre-existing event, occurring after the first dose of study drug until 30 days after the last dose of study drug. Severity of AEs was graded using the National Cancer Institute CTCAE version 5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

    Measured: up to Week 58

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start22 Feb 2023
  3. Primary completion7 Jan 2025
  4. Study completion21 Nov 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
619 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620836
Sponsor's protocol ID
INCB 54707-302
Other IDs
2022-501753-36-00
Acronym
STOP-HS2
Status last verified
Oct 2026
First submitted
10 Nov 2022
Last updated
5 Nov 2026
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

Publications

  • Porter ML, Martorell A, Sayed CJ, Bechara FG, Lev-Tov H, Hsiao JL, Frew JW, Reguiai Z, Gooderham MJ, Goldfarb N, van der Zee HH, Del Marmol V, Marzano AV, Ehst BD, Ackerman LS, Hayama K, Tian C, Kelley J, Zhen H, Kirby JS, Brown K, Santos LL, Zouboulis CC. Povorcitinib for hidradenitis suppurativa: the randomized, double-blind, placebo-controlled STOP-HS1 and STOP-HS2 phase 3 trials. Nat Med. 2026 Aug;32(8):3071-3081. doi: 10.1038/s41591-026-04534-z. Epub 2026 Jul 23.

    PubMed 42493571

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Povorcitinib in people with Hidradenitis Suppurativa (HS), run by Incyte Corporation at 101 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Germany, Australia, Canada, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05620836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in