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Hidradenitis Suppurativa (HS)Phase 3STOP-HS LTENCT06212999

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib 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 165 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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]). 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?
No, everyone receives an active treatment
How many people
617 participants
Where
165 sitesin 17 countries
Study dates
30 Jan 2024to 26 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

165 sites in 17 countries.

165 sites in 17 countries

United States61 sites

  • Investigative Site US235

    Arlington, Texas, 76011

  • Investigative Site US224

    Baltimore, Maryland, 21287

  • Investigative Site US305

    Baton Rouge, Louisiana, 70809

  • Investigative Site US218

    Bellaire, Texas, 77401

  • Investigative Site US340

    Bellaire, Texas, 77401

  • Investigative Site US215

    Bexley, Ohio, 43209

  • Investigative Site US339

    Bexley, Ohio, 43209

  • Investigative Site US330

    Boardman, Ohio, 44512

  • Investigative Site US225

    Boston, Massachusetts, 02115

  • Investigative Site US304

    Boston, Massachusetts, 02215

  • Investigative Site US341

    Bowling Green, Kentucky, 42104

  • Investigative Site US310

    Brighton, Massachusetts, 02135

  • Investigative Site US205

    Chapel Hill, North Carolina, 27516

  • Investigative Site US314

    Cincinnati, Ohio, 45219

  • Investigative Site US309

    Clearwater, Florida, 33614

  • Investigative Site US312

    Cleveland, Ohio, 44106

  • Investigative Site US230

    East Windsor, New Jersey, 08520

  • Investigative Site US213

    Fort Gratiot, Michigan, 48059

  • Investigative Site US307

    Fort Smith, Arkansas, 72916

  • Investigative Site US203

    Gahanna, Ohio, 43230

  • Investigative Site US317

    Hialeah, Florida, 33012-3618

  • Investigative Site US306

    Hollywood, Florida, 33021

  • Investigative Site US320

    Hollywood, Florida, 33021

  • Investigative Site US206

    Indianapolis, Indiana, 46250

  • Investigative Site US337

    Indianapolis, Indiana, 46250

  • Investigative Site US324

    Kew Gardens, New York, 11415

  • Investigative Site US315

    Laguna Niguel, California, 92677

  • Investigative Site US223

    Los Angeles, California, 90033

  • Investigative Site US209

    Louisville, Kentucky, 40241

  • Investigative Site US316

    Maitland, Florida, 32751

  • Investigative Site US227

    Margate, Florida, 33063

  • Investigative Site US311

    Marietta, Georgia, 30060

  • Investigative Site US325

    Marriottsville, Maryland, 21104

  • 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, 10028

  • Investigative Site US313

    Norfolk, Virginia, 23502

  • Investigative Site US321

    North Miami Beach, Florida, 33162-4708

  • Investigative Site US222

    Oakland, California, 94611

  • Investigative Site US200

    Ocala, Florida, 34470

  • Investigative Site US238

    Pflugerville, Texas, 78660

  • Investigative Site US303

    Phoenix, Arizona, 85006

  • Investigative Site US300

    Plano, Texas, 75025

  • Investigative Site US301

    Portland, Oregon, 97201

  • Investigative Site US318

    Portsmouth, New Hampshire, 03801

  • Investigative Site US221

    Quincy, Massachusetts, 02169

  • Investigative Site US210

    Rochester, New York, 14620

  • Investigative Site US214

    Rogers, Arkansas, 72758

  • Investigative Site US234

    San Antonio, Texas, 78213

  • Investigative Site US226

    San Diego, California, 92103

  • Investigative Site US240

    Scottsdale, Arizona, 85255

  • Investigative Site US308

    Spokane, Washington, 99202

  • Investigative Site US302

    St Louis, Missouri, 63110

  • Investigative Site US228

    Tampa, Florida, 33609

  • Investigative Site US201

    Tampa, Florida, 33613

  • Investigative Site US217

    Waterford, Michigan, 48328

  • Investigative Site US220

    West Dundee, Illinois, 60118

Other trials in United States

Germany15 sites

  • Investigative Site DE202

    Berlin, 10117

  • Investigative Site DE203

    Bochum, 44791

  • Investigative Site DE305

    Darmstadt, 64283

  • Investigative Site DE201

    Dessau, 06847

  • Investigative Site DE302

    Dresden, 01307

  • Investigative Site DE306

    Düsseldorf, 40225

  • Investigative Site DE207

    Erlangen, 91054

  • Investigative Site DE301

    Frankfurt, 60590

  • Investigative Site DE208

    Göttingen, 37075

  • Investigative Site DE303

    Hamburg, 20246

  • Investigative Site DE300

    Hanover, 30159

  • Investigative Site DE205

    Heidelberg, 69120

  • Investigative Site DE200

    Kiel, 24105

  • Investigative Site DE307

    Memmingen, 87700

  • Investigative Site DE206

    Merzig, 66663

Other trials in Germany

Canada14 sites

  • Investigative Site CA304

    Barrie, Ontario, L4M 7G1

  • Investigative Site CA202

    Calgary, Alberta, T3E 0B2

  • Investigative Site CA204

    Edmonton, Alberta, T6G 1C3

  • Investigative Site CA205

    Fredericton, New Brunswick, E3B 1G9

  • Investigative Site CA308

    Hamilton, Ontario, L8L 3C3

  • Investigative Site CA303

    London, Ontario, N6H 5L5

  • Investigative Site CA207

    Mississauga, Ontario, L4W 0C2

  • Investigative Site CA307

    Montreal, Quebec, H2X 2V1

  • Investigative Site CA302

    Peterborough, Ontario, K9J 5K2

  • Investigative Site CA208

    Richmond Hill, Ontario, L4B 1L1

  • Investigative Site CA206

    Saint-Jérôme, Quebec, J7Z 7E2

  • Investigative Site CA203

    St. John's, A1A 4Y3

  • Investigative Site CA200

    Surrey, British Columbia, V3V 0C6

  • Investigative Site CA301

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

France13 sites

  • Investigative Site FR305

    Bordeaux, 33000

  • Investigative Site FR303

    Brest, 29609

  • Investigative Site FR205

    Dijon, 21000

  • Investigative Site FR307

    Le Mans, 72037

  • Investigative Site FR204

    Lyon, 69437

  • Investigative Site FR304

    Marseille, 13385

  • Investigative Site FR302

    Nantes, 44093

  • Investigative Site FR203

    Nice, 06200

  • Investigative Site FR300

    Paris, 75010

  • Investigative Site FR206

    Reims, 51100

  • Investigative Site FR202

    Rouen, 76031

  • Investigative Site FR301

    Saint-Priest-en-Jarez, 42270

  • Investigative Site FR306

    Toulouse, 31059

Other trials in France

Spain11 sites

  • Investigative Site ES203

    Alicante, 03010

  • Investigative Site ES302

    Badalona, 08916

  • Investigative Site ES303

    Barcelona, 08003

  • Investigative Site ES301

    Granada, 18014

  • Investigative Site ES202

    Las Palmas de Gran Canaria, 35010

  • Investigative Site ES201

    Madrid, 28009

  • Investigative Site ES205

    Madrid, 28040

  • Investigative Site ES305

    Madrid, 28041

  • Investigative Site ES200

    Manises, 46940

  • Investigative Site ES300

    Pontevedra, 36001

  • Investigative Site ES304

    Santiago de Compostela, 15706

Other trials in Spain

Japan8 sites

  • Investigative Site JP301

    Ginowan-shi, 901-2725

  • Investigative Site JP304

    Itabashi-ku, 173-8610

  • Investigative Site JP305

    Kurume-shi, 830-0011

  • Investigative Site JP300

    Kyoto, 602-8566

  • Investigative Site JP303

    Niigata, 951-8520

  • Investigative Site JP308

    Sapporo, 060-8648

  • Investigative Site JP302

    Sendai, 980-8574

  • Investigative Site JP309

    Shinjuku-ku, 160-0023

Other trials in Japan

Australia7 sites

  • Investigative Site AU201

    Carlton, Victoria, 03053

  • Investigative Site AU203

    Charlestown, New South Wales, 02290

  • Investigative Site AU205

    Kogarah, New South Wales, 02217

  • 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

Poland7 sites

  • Investigative Site PL203

    Lublin, 20573

  • Investigative Site PL304

    Ostrowiec Świętokrzyski, 27-400

  • Investigative Site PL200

    Rzeszów, 35-055

  • Investigative Site PL201

    Warsaw, 02-507

  • Investigative Site PL202

    Warsaw, 02-962

  • Investigative Site PL301

    Wroclaw, 50-566

  • Investigative Site PL302

    Wroclaw, 51-503

Other trials in Poland

Italy6 sites

  • Investigative Site IT200

    Ancona, 60126

  • Investigative Site IT207

    Catania, 95123

  • Investigative Site IT202

    Milan, 20122

  • Investigative Site IT206

    Pisa, 56126

  • Investigative Site IT205

    Roma, 00136

  • Investigative Site IT201

    Rozzano, 20089

Other trials in Italy

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

Belgium3 sites

  • Investigative Site BE300

    Brussels, 01070

  • Investigative Site BE301

    Ghent, 09000

  • Investigative Site BE302

    Liège, 04000

Other trials in Belgium

Greece3 sites

  • Investigative Site GR300

    Athens, 12462

  • Investigative Site GR303

    Athens, 16121

  • Investigative Site GR302

    Thessaloniki, 56403

Other trials in Greece

Netherlands3 sites

  • Investigative Site NL302

    Breda, 4818 CK

  • Investigative Site NL303

    Groningen, 9713 GZ

  • Investigative Site NL301

    Rotterdam, 3015 GD

Other trials in Netherlands

United Kingdom3 sites

  • Investigative Site GB202

    Birmingham, B15 2TH

  • Investigative Site GB200

    Dudley, DY1 2HQ

  • Investigative Site GB203

    Salford, M6 8HD

Other trials in United Kingdom

Austria2 sites

  • Investigative Site AT306

    Inssbruck, 06020

  • Investigative Site AT305

    Vienna, 01090

Other trials in Austria

Czechia2 sites

  • Investigative Site CZ301

    Ostrava - Poruba, 708 52

  • Investigative Site CZ300

    Prague, 150 06

Other trials in Czechia

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 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]).

Being tested
Povorcitinib
Keywords
Hidradenitis Suppurativa, Hidradenitis, Acne inversa, HS, Povorcitinib, Long-Term Extension (LTE), INCB054707
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

Study groups in NCT06212999
Study groupRoleWhat they receive
Cohort AExperimentalPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Receives: Drug: Povorcitinib
Cohort BExperimentalPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Receives: Drug: Povorcitinib
Cohort CExperimentalPovorcitinib at the protocol-defined dose strength based on cohort assignment.
Receives: Drug: Povorcitinib

What is being measured

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

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

    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.

    Measured: up to approximately 56 weeks

Secondary outcomes (15)

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

    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.

    Measured: up to approximately 56 weeks

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

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

    Measured: up to approximately 56 weeks

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

    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.

    Measured: up to approximately 56 weeks

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

    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.

    Measured: up to approximately 56 weeks

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

    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.

    Measured: up to approximately 56 weeks

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

    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.

    Measured: up to approximately 56 weeks

  7. Proportion of participants with flare at each visit

    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.

    Measured: up to approximately 56 weeks

  8. Time to first flare

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

    Measured: up to approximately 56 weeks

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

    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.

    Measured: up to approximately 56 weeks

  10. Mean change from baseline of parent study 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: up to approximately 56 weeks

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

    Measured: 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

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

    Measured: up to approximately 56 weeks

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

    Measured: up to approximately 56 weeks

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

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

    Measured: up to approximately 56 weeks

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

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

    Measured: up to approximately 56 weeks

Timeline

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

  1. First posted19 Jan 2024
  2. Study start30 Jan 2024
  3. Primary completion26 Dec 2026 (estimated)
  4. Study completion26 Dec 2026 (estimated)

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212999
Sponsor's protocol ID
INCB 54707-312
Other IDs
2023-507204-31-00, 2023
Acronym
STOP-HS LTE
Status last verified
Aug 2026
First submitted
9 Jan 2024
Last updated
25 Aug 2026
Results posted
No
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

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 165 sites in 17 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Germany, Canada, France, Spain and 12 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. 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?

This study is still under way. Results are not available in the source record yet.

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 with Treatment-Emergent Adverse Events (TEAEs) (time frame: up to approximately 56 weeks). 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 NCT06212999.

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 25 Aug 2026.

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