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Hidradenitis Suppurativa (HS)Phase 3STOP-HS1NCT05620823

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

A Phase 3 study testing Povorcitinib in people with Hidradenitis Suppurativa (HS), run by Incyte Corporation at 104 sites in 12 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
608 participants
Where
104 sitesin 12 countries
Study dates
19 Dec 2022to 23 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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.
Show all 9Show fewer
  • 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

104 sites in 12 countries.

104 sites in 12 countries

United States37 sites

  • Investigative Site US331

    Albuquerque, New Mexico, 87102

  • Investigative Site US335

    Arkansas City, Arkansas, 72758

  • Investigative Site US333

    Baltimore, Maryland, 21287

  • Investigative Site US340

    Bellaire, Texas, 77401

  • Investigative Site US318

    Beverly, Massachusetts, 01915

  • Investigative Site US339

    Bexley, Ohio, 43209

  • Investigative Site US330

    Boardman, Ohio, 44512

  • Investigative Site US306

    Boca Raton, Florida, 33486

  • Investigative Site US320

    Boca Raton, Florida, 33486

  • Investigative Site US304

    Boston, Massachusetts, 02215

  • Investigative Site US341

    Bowling Green, Kentucky, 42103

  • Investigative Site US310

    Brighton, Massachusetts, 02135

  • Investigative Site US327

    Chicago, Illinois, 60612

  • Investigative Site US314

    Cincinnati, Ohio, 45219

  • Investigative Site US312

    Cleveland, Ohio, 44106

  • Investigative Site US325

    Columbia, Maryland, 21045

  • Investigative Site US307

    Fort Smith, Arkansas, 72916

  • Investigative Site US317

    Hialeah, Florida, 33012-3618

  • Investigative Site US337

    Indianapolis, Indiana, 46250

  • Investigative Site US324

    Kew Gardens, New York, 11415

  • Investigative Site US315

    Laguna Niguel, California, 92677

  • Investigative Site US326

    Los Angeles, California, 90045

  • Investigative Site US338

    Margate, Florida, 33063

  • Investigative Site US311

    Marietta, Georgia, 30060-1047

  • Investigative Site US334

    Metairie, Louisiana, 70006

  • Investigative Site US313

    Norfolk, Virginia, 23502

  • Investigative Site US321

    North Miami Beach, Florida, 33162-4708

  • Investigative Site US316

    Orlando, Florida, 32819

  • Investigative Site US303

    Phoenix, Arizona, 85006

  • Investigative Site US300

    Plano, Texas, 75025

  • Investigative Site US301

    Portland, Oregon, 97223

  • Investigative Site US323

    San Francisco, California, 94118

  • Investigative Site US319

    Skokie, Illinois, 60077

  • Investigative Site US308

    Spokane, Washington, 99202

  • Investigative Site US302

    St Louis, Missouri, 63110

  • Investigative Site US328

    Tampa, Florida, 33612

  • Investigative Site US336

    Tampa, Florida, 33613

Other trials in United States

Japan10 sites

  • Investigative Site JP305

    Kurume-shi, 830-0011

  • Investigative Site JP300

    Kyoto, 602-8566

  • Investigative Site JP301

    Nakagami-gun, 903-0215

  • Investigative Site JP303

    Niigata, 951-8520

  • Investigative Site JP307

    Nishinomiya-shi, 663-8186

  • Investigative Site JP308

    Sapporo, 060-8648

  • Investigative Site JP302

    Sendai, 980-8574

  • Investigative Site JP309

    Shinjuku-ku, 160-0023

  • Investigative Site JP304

    tabashi City, 173-8610

  • Investigative Site JP306

    Tsukuba, 305-8576

Other trials in Japan

Canada8 sites

  • Investigative Site CA304

    Barrie, Ontario, L4M 1G7

  • Investigative Site CA308

    Hamilton, Ontario, L8L 3C3

  • Investigative Site CA306

    Laval, Quebec, H7N 6L2

  • Investigative Site CA303

    London, Ontario, N6H 5L5

  • Investigative Site CA307

    Montreal, Quebec, H2K 4L5

  • Investigative Site CA302

    Peterborough, Ontario, K9J 5K2

  • Investigative Site CA309

    Québec, Quebec, G1V 4T3

  • Investigative Site CA301

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

France8 sites

  • Investigative Site FR305

    Bordeaux, 33000

  • Investigative Site FR303

    Brest, 29609

  • Investigative Site FR307

    Le Mans, 72037

  • Investigative Site FR304

    Marseille, 13385

  • Investigative Site FR302

    Nantes, 44093

  • Investigative Site FR300

    Paris, 75010

  • Investigative Site FR301

    Saint-Priest-en-Jarez, 42270

  • Investigative Site FR306

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Investigative Site DE305

    Darmstadt, 64283

  • Investigative Site DE302

    Dresden, 01307

  • Investigative Site DE306

    Düsseldorf, 40225

  • Investigative Site DE301

    Frankfurt am Main, 60590

  • Investigative Site DE303

    Hamburg, 20246

  • Investigative Site DE300

    Hanover, 30519

  • Investigative Site DE304

    Langenau, 89129

  • Investigative Site DE307

    Memmingen, 87700

Other trials in Germany

Austria7 sites

  • Investigative Site AT304

    Graz, 08036

  • Investigative Site 00A

    Innsbruck, 06020

  • Investigative Site AT306

    Innsbruck, 06020

  • Investigative Site AT302

    Linz, 04020

  • Investigative Site AT305

    Vienna, 01090

  • Investigative Site AT301

    Vienna, 01100

  • Investigative Site AT300

    Vienna, 01130

Other trials in Austria

Belgium7 sites

  • Investigative Site BE300

    Brussels, 01070

  • Investigative Site BE304

    Brussels, 01200

  • Investigative Site BE301

    Ghent, 09000

  • Investigative Site BE306

    Ghent, 09000

  • Investigative Site BE305

    Leuven, 03000

  • Investigative Site BE302

    Liège, 04000

  • Investigative Site BE303

    Namur, 05000

Other trials in Belgium

Spain6 sites

  • Investigative Site ES302

    Badalona, 08916

  • Investigative Site ES303

    Barcelona, 08003

  • Investigative Site ES301

    Granada, 18014

  • Investigative Site ES305

    Madrid, 28041

  • Investigative Site ES300

    Pontevedra, 36001

  • Investigative Site ES304

    Santiago de Compostela, 15706

Other trials in Spain

Greece4 sites

  • Investigative Site GR300

    Athens, 12462

  • Investigative Site GR303

    Athens, 16121

  • Investigative Site GR301

    Thessaloniki, 54643

  • Investigative Site GR302

    Thessaloniki, 56403

Other trials in Greece

Poland4 sites

  • Investigative Site PL304

    Ostrowiec, 27-400

  • Investigative Site PL303

    Poznan, 60-529

  • Investigative Site PL301

    Wroclaw, 50-566

  • Investigative Site PL302

    Wroclaw, 51-318

Other trials in Poland

Netherlands3 sites

  • Investigative Site NL302

    Breda, 4818 CK

  • Investigative Site NL303

    Groningen, 9713 GZ

  • Investigative Site NL301

    Rotterdam, 3015 GD

Other trials in Netherlands

Czechia2 sites

  • Investigative Site CZ301

    Ostrava - Poruba, 708 52

  • Investigative Site CZ300

    Prague, 150 06

Other trials in Czechia

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, Hidradenitis, Acne inversa, HS, INCB054707, Povorcitinib
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 NCT05620823
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. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)

    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.

    Measured: Week 12

Secondary outcomes (22)

  1. 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: Week 12

  2. Proportion of participants with flare

    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.

    Measured: 12 weeks

  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.

    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).

    Measured: Week 12

  4. Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.

    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.

    Measured: Week 12

  5. Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score

    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).

    Measured: Week 12

  6. Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit

    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.

    Measured: 54 weeks

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

    Defined as mean change of Abscess count relative to baseline.

    Measured: 54 weeks

  8. Percentage change from baseline in abscess count at every visit

    Percent change from baseline in number of abscess(es)

    Measured: 54 weeks

  9. 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

  10. Percentage change from baseline in inflammatory nodule count at each visit.

    Defined as percent change from baseline in number of inflammatory nodule(s)

    Measured: 54 weeks

  11. 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

  12. Percentage change from baseline in draining tunnel count at each visit.

    Defined as percent change from baseline in number of draining tunnel(s)

    Measured: 54 weeks

  13. Extension Period: Proportion of participants who achieve HiSCR

    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.

    Measured: Week 24

  14. Extension Period: Proportion of participants who achieve 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: Week 24

  15. Extension Period: Proportion of participants with flare

    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.

    Measured: From Week 12 through Week 24

  16. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3

    Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

    Measured: Week 24

  17. Extension Period: Proportion of participants who achieve HiSCR

    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

    Measured: Week 54

  18. Extension Period: Proportion of participants who achieve 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: Week 54

  19. Extension Period : Proportion of participants with flare

    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.

    Measured: From Week 12 through Week 54

  20. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3.

    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.

    Measured: Week 54

  21. Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit

    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.

    Measured: From Week 12 through Week 54

  22. Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit

    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.

    Measured: From Week 12 through Week 54

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 start19 Dec 2022
  3. Primary completion3 Feb 2025
  4. Study completion23 Dec 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
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620823
Sponsor's protocol ID
INCB 54707-301
Other IDs
2022-501752-29-00
Acronym
STOP-HS1
Status last verified
Feb 2026
First submitted
10 Nov 2022
Last updated
10 Feb 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

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 104 sites in 12 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 9 inclusion and 5 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Japan, Canada, France, Germany and 7 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) (time frame: 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 NCT05620823, 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 10 Feb 2026.

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