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Hidradenitis SuppurativaPhase 3NCT06958211

Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

A Phase 3 study testing Ruxolitinib Cream in people with Hidradenitis Suppurativa, run by Incyte Corporation at 107 sites in 9 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 the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Ruxolitinib Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
573 participants
Where
107 sitesin 9 countries
Study dates
12 Jun 2025to 11 Jul 2027
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of HS for at least 6 months prior to screening visit.
  • Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:
  • A total AN count of at least 4, with no draining tunnels AND
  • Affecting at least 2 distinct anatomical areas
  • Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
  • Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.
  • Further inclusion criteria apply.

Who cannot join

  • Body surface areas to be treated exceed 20% BSA at screening or baseline
  • Presence of draining tunnels at screening or baseline.
  • Medical history including 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 criteria.
  • Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
  • Further exclusion criteria apply.

Trial locations and contacts

107 sites in 9 countries.

107 sites in 9 countries

United States67 sites

  • Investigative Site US217

    Albuquerque, New Mexico, 87102

  • Investigative Site US238

    Ann Arbor, Michigan, 48103

  • Investigative Site US248

    Arlington, Virginia, 22206

  • Investigative Site US230

    Auburn Hills, Michigan, 48326

  • Investigative Site US255

    Austin, Texas, 78759

  • Investigative Site US257

    Birmingham, Alabama, 35203

  • Investigative Site US218

    Birmingham, Alabama, 35244

  • Investigative Site US256

    Bluffton, South Carolina, 29910

  • Investigative Site US208

    Boca Raton, Florida, 33486

  • Investigative Site US219

    Brooklyn, New York, 11203

  • Investigative Site US244

    Castle Rock, Colorado, 80109

  • Investigative Site US228

    Cleveland, Ohio, 44124

  • Investigative Site US231

    Columbus, Georgia, 31904

  • Investigative Site US243

    Columbus, Ohio, 43213

  • Investigative Site US249

    Columbus, Ohio, 43213

  • Investigative Site US252

    Cromwell, Connecticut, 06416

  • Investigative Site US260

    Cypress, Texas, 77429

  • Investigative Site US209

    Danville, Virginia, 24541

  • Investigative Site US246

    Elmhurst, New York, 11373

  • Investigative Site US262

    Encino, California, 91436

  • Investigative Site US269

    Fairport, New York, 14450

  • Investigative Site US222

    Fountain Valley, California, 92708

  • Investigative Site US254

    Gambrills, Maryland, 21054

  • Investigative Site US203

    Hialeah, Florida, 33012-3618

  • Investigative Site US235

    Hoboken, New Jersey, 07030

  • Investigative Site US259

    Huntersville, North Carolina, 28078

  • Investigative Site US258

    Jacksonville, Florida, 32216

  • Investigative Site US213

    Kew Gardens, New York, 11415

  • Investigative Site US264

    Lake Charles, Louisiana, 70601

  • Investigative Site US216

    Las Vegas, Nevada, 89145

  • Investigative Site US211

    Los Angeles, California, 90045

  • Investigative Site US237

    Los Angeles, California, 90056

  • Investigative Site US206

    Maitland, Florida, 32751

  • Investigative Site US201

    Marriottsville, Maryland, 21104

  • Investigative Site US223

    Miami, Florida, 33136

  • Investigative Site US241

    Miami, Florida, 33147

  • Investigative Site US202

    Miami, Florida, 33173

  • Investigative Site US253

    Milford, Massachusetts, 01757

  • Investigative Site US210

    Milwaukee, Wisconsin, 53226

  • Investigative Site US212

    Missoula, Montana, 59804

  • Investigative Site US239

    Montgomery, Alabama, 36117

  • Investigative Site US267

    Mt. Pleasant, South Carolina, 29464

  • Investigative Site US227

    Needham, Massachusetts, 02492

  • Investigative Site US266

    New Orleans, Louisiana, 70115

  • Investigative Site US242

    New York, New York, 10075

  • Investigative Site US229

    Norfolk, Virginia, 23502

  • Investigative Site US234

    Northridge, California, 91325

  • Investigative Site US215

    Phoenix, Arizona, 85006

  • Investigative Site US261

    Phoenix, Arizona, 85037

  • Investigative Site US205

    Plainfield, Indiana, 46168

  • Investigative Site US226

    Plymouth Meeting, Pennsylvania, 19462

  • Investigative Site US204

    Portland, Oregon, 97201

  • Investigative Site US270

    Prosper, Texas, 75078

  • Investigative Site US245

    Rochester, New York, 14620

  • Investigative Site US225

    Sandy Springs, Georgia, 30328

  • Investigative Site US250

    Santa Ana, California, 92706

  • Investigative Site US265

    Seattle, Washington, 98105

  • Investigative Site US207

    Skokie, Illinois, 60077

  • Investigative Site US224

    Spokane, Washington, 99202

  • Investigative Site US251

    St Louis, Missouri, 63110-1010

  • Investigative Site US232

    Sugar Land, Texas, 77479

  • Investigative Site US214

    Tampa, Florida, 33609

  • Investigative Site US247

    Tampa, Florida, 33612

  • Investigative Site US240

    Tucson, Arizona, 85718

  • Investigative Site US271

    Wildwood, Missouri, 63040

  • Investigative Site US263

    Winston-Salem, North Carolina, 27104

  • Investigative Site US268

    Worcester, Massachusetts, 01605

Other trials in United States

Canada9 sites

  • Investigative Site CA209

    Edmonton, Alberta, T5K1X3

  • Investigative Site CA207

    Fredericton, New Brunswick, E3B 1G9

  • Investigative Site CA202

    Hamilton, Ontario, L8L 3C3

  • Investigative Site CA203

    London, Ontario, N6H 5L5

  • Investigative Site CA204

    Markham, Ontario, L3P 1X3

  • Investigative Site CA205

    Mississauga, Ontario, L4W 0C2

  • Investigative Site CA208

    Saskatoon, Saskatchewan, S7K 0H6

  • Investigative Site CA206

    St. John's, A1E 1V4

  • Investigative Site CA201

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Spain8 sites

  • Investigative Site ES205

    Barcelona, 08041

  • Investigative Site ES208

    Esplugues de Llobregat, 08950

  • Investigative Site ES201

    Granada, 18014

  • Investigative Site ES206

    Granollers, 08402

  • Investigative Site ES202

    Las Palmas de Gran Canaria, 35010

  • Investigative Site ES203

    Madrid, 28041

  • Investigative Site ES207

    Manises, 46940

  • Investigative Site ES204

    Santiago de Compostela, 15706

Other trials in Spain

Germany6 sites

  • Investigative Site DE207

    Bad Bentheim, 48455

  • Investigative Site DE206

    Göttingen, 37075

  • Investigative Site DE202

    Hanover, 30159

  • Investigative Site DE203

    Kiel, 24105

  • Investigative Site DE205

    Langenau, 89129

  • Investigative Site DE204

    Merzig, 66663

Other trials in Germany

Belgium4 sites

  • Investigative Site BE204

    Brussels, 01070

  • Investigative Site BE201

    Ghent, 09000

  • Investigative Site BE203

    Ghent, 09000

  • Investigative Site BE202

    Leuven, 03000

Other trials in Belgium

France4 sites

  • Investigative Site FR201

    Reims, 51100

  • Investigative Site FR203

    Rouen, 76031

  • Investigative Site FR204

    Saint-Etienne, 42055

  • Investigative Site FR202

    Toulouse, 31059

Other trials in France

Poland4 sites

  • Investigative Site PL202

    Lublin, 20-607

  • Investigative Site LP204

    Poznan, 60-309

  • Investigative Site PL201

    Rzeszów, 35-055

  • Investigative Site PL203

    Wroclaw, 54-144

Other trials in Poland

Bulgaria3 sites

  • Investigative Site BG201

    Sevlievo, 05400

  • Investigative Site BG202

    Sofia, 01431

  • Investigative Site BG203

    Sofia, 01592

Other trials in Bulgaria

Netherlands2 sites

  • Investigative Site NL203

    Amsterdam, 1105 AZ

  • Investigative Site NL201

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Being tested
Ruxolitinib Cream, Vehicle Cream
Keywords
Hidradenitis suppurativa, skin disease, ruxolitinb cream
Medical subject headings
Hidradenitis Suppurativa, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ruxolitinib CreamDrug

    Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

  • Vehicle CreamDrug

    Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study groups in NCT06958211
Study groupRoleWhat they receive
Ruxolitinib 1.5 % CreamExperimentalParticipants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Receives: Drug: Ruxolitinib Cream
Vehicle CreamPlacebo comparatorParticipants received vehicle cream, applied topically to the affected area as defined by the protocol.
Receives: Drug: Vehicle Cream

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 (HS) Clinical Response 75 (HiSCR75) from baseline

    HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and/or inflammatory nodule (AN) count with no increase from baseline in abscess or draining tunnel count.

    Measured: Week 16

Secondary outcomes (35)

  1. Proportion of participants with ≥ 1 flare

    Defined as a ≥ 25% increase in AN count with a minimum increase in total AN count of 2 relative to baseline.

    Measured: Up to 16 weeks

  2. Proportion of participants who achieve HiSCR50

    Defined as a ≥ 50 reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.

    Measured: Week 16

  3. Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3

    Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS3, defined as at least 3-unit reduction from baseline in the Skin Pain NRS.

    Measured: Week 16

  4. Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline

    Treatment IR-Population defined as participants who had an inadequate response, intolerance, or contraindication to prior topical or systemic medications for HS. 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: Week 16

  5. Treatment-IR Population: Proportion of participants with ≥ 1 HS flare

    Defined as a ≥ 25% increase in total AN count with a minimum increase in AN count of 2 relative to baseline.

    Measured: Up to 16 weeks

  6. Treatment-IR Population: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3

    Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS3, defined as at least 3-unit reduction from baseline in the Skin Pain NRS.

    Measured: Week 16

  7. Proportion of participants who achieve HiSCR50/75/90/100 at each postbaseline visit

    Defined as a ≥ 50%/75%/90%/100% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.

    Measured: Up to 16 weeks

  8. Extension Period: Proportion of participants with ≥ 1 HS flare

    Defined as a ≥ 25% increase in total AN count with a minimum increase in AN count of 2 relative to baseline.

    Measured: From Week 16 through Week 52

  9. Proportion of participants who achieve abscess and/or inflammatory nodule (AN)75 at each postbaseline visit

    Defined as a ≥ 75% reduction from baseline in total AN count.

    Measured: Up to 52 weeks

  10. Mean change from baseline in total AN count at each postbaseline visit

    Defined as mean change in total AN count.

    Measured: Up to 52 weeks

  11. Percentage change from baseline in total AN count at each postbaseline visit

    Defined as percent change from baseline in total AN count.

    Measured: Up to 52 weeks

  12. Mean change from baseline in abscess count at each postbaseline visit

    Defined as mean change of abscess(es) count relative to baseline.

    Measured: Up to 52 weeks

  13. Percentage change from baseline in abscess count at each postbaseline visit

    Percent Change from baseline in number of abscess(es).

    Measured: Up to 52 weeks

  14. Mean change from baseline in inflammatory nodule count at each postbaseline visit

    Defined as mean change of inflammatory nodule count relative to baseline.

    Measured: Up to 52 weeks

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

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

    Measured: Up to 52 weeks

  16. Proportion of participants with presence of draining tunnels at each postbaseline visit

    Participants with presence of draining tunnels.

    Measured: Up to 52 weeks

  17. Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3 at each postbaseline visit

    Participants with a Skin Pain score of at least 3 at baseline and who achieve Skin Pain NRS3, defined as at least 3-unit reduction from baseline in the Skin Pain NRS.

    Measured: Up to 52 weeks

  18. Proportion of participants who achieve Itch Numeric Rating Scale (NRS)30 among participants with baseline Itch NRS score ≥ 3 at each postbaseline visit

    Participants with a Itch score of at least 3 at baseline and who achieve Itch NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Itch NRS.

    Measured: Up to 52 weeks

  19. Proportion of participants who achieve Patient Global Impression of Change (PGIC) at each postbaseline visit

    The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.

    Measured: Up to 52 weeks

  20. Proportion of participants who achieve PGIC score 1 or 2 at each postbaseline visit

    The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.

    Measured: Up to 52 weeks

  21. Patient Global Impression of Severity (PGIS) score at each postbaseline visit

    The PGIS is a single-item, self-reporting measure in which the participant rates the severity of their overall status over the past week based on a 5-point scale: (1) none, (2) mild, (3) moderate, (4) severe, and (5) very severe.

    Measured: Up to 52 weeks

  22. Change from baseline in PGIS Score at each postbaseline visit

    The PGIS is a single-item, self-reporting measure in which the participant rates the severity of their overall status over the past week based on 5-point scale: (1) none, (2) mild, (3) moderate, (4) severe, and (5) very severe.

    Measured: Up to 52 weeks

  23. Proportion of participants who achieve status of Dermatology Life Quality Index (DLQ1)4 at each postbaseline visit

    Defined as a ≥ 4-point reduction in DLQI score relative to baseline. The DLQI is a simple, 10-question, validated questionnaire to measure how much a skin problem has affected an adult participant over the previous 7 days, across symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.

    Measured: Up to 52 weeks

  24. Proportion of participants who achieve status of Children's Dermatology Life Quality Index (CDLQ1)6 at each postbaseline visit

    Defined as a ≥ 6-point reduction in CDLQI score relative to baseline. The CDLQI is a 10-question, validated questionnaire to measure the impact of skin disease on the lives of children over the previous 7 days.

    Measured: Up to 52 weeks

  25. Change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit

    The HiSQoL is a 17-item, HS-specific, health-related, quality-of-life instrument with a 7-day recall period used to assess HS symptoms and the impact of HS problems on quality of life.

    Measured: Up to 52 weeks

  26. Percent change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit

    The HiSQoL is a 17-item, HS-specific, health-related, quality-of-life instrument with a 7-day recall period used to assess HS symptoms and the impact of HS problems on quality of life.

    Measured: Up to 52 weeks

  27. Change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit

    The HiSQoL-AA is a 15-item instrument with a 7-day recall period used to assess HS symptoms and experiences of HS in adolescent.

    Measured: Up to 52 weeks

  28. Percent change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit

    The HiSQoL-AA is a 15-item instrument with a 7-day recall period used to assess HS symptoms and experiences of HS in adolescent.

    Measured: Up to 52 weeks

  29. Change from baseline in EuroQol 5-dimension 5-level scale (EQ-5D-5L) score at each postbaseline visit

    The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

    Measured: Up to 52 weeks

  30. Treatment-IR Population: Change from baseline in total abscess count at each postbaseline visit

    Defined as change from baseline in total abscess count.

    Measured: Up to 52 weeks

  31. Treatment-IR Population: Percent change from baseline in total abscess count at each postbaseline visit

    Percent Change from baseline in total abscess count.

    Measured: Up to 52 weeks

  32. Treatment-IR Population: Change from baseline in total inflammatory nodule count at each postbaseline visit

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

    Measured: Up to 52 weeks

  33. Treatment-IR Population: Percent change from baseline in total inflammatory nodule count at each postbaseline visit

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

    Measured: Up to 52 weeks

  34. Treatment-IR Population: Proportion of participants with presence of draining tunnels at each postbaseline visit

    Participants with presence of draining tunnels.

    Measured: Up to 52 weeks

  35. Number of Treatment Emergent Adverse Events (TEAEs)

    A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first application of study cream.

    Measured: Up to 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 posted6 May 2025
  2. Study start12 Jun 2025
  3. Primary completion9 Oct 2026 (estimated)
  4. Study completion11 Jul 2027 (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
573 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958211
Sponsor's protocol ID
INCB018424-325
Other IDs
2024-517633-40-00
Status last verified
Jul 2026
First submitted
25 Apr 2025
Last updated
8 Jul 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 Ruxolitinib Cream in people with Hidradenitis Suppurativa, run by Incyte Corporation at 107 sites in 9 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 7 inclusion and 6 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Canada, Spain, Germany, Belgium and 4 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?

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 who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline (time frame: Week 16). 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 NCT06958211.

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 8 Jul 2026.

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