Hidradenitis SuppurativaPhase 3NCT06959225
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
A Phase 3 study testing Ruxolitinib Cream in people with Hidradenitis Suppurativa, run by Incyte Corporation at 101 sites in 8 countries.
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
- 580 participants
- Where
- 101 sitesin 8 countries
- Study dates
- 23 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
101 sites in 8 countries.
101 sites in 8 countries
United States59 sites
Investigative Site US061
Atlanta, Georgia, 30322
Investigative Site US053
Atlanta, Georgia, 30331
Investigative Site US059
Aurora, Colorado, 80045
Investigative Site US050
Baton Rouge, Louisiana, 70809
Investigative Site US015
Bexley, Ohio, 43209
Investigative Site US003
Boston, Massachusetts, 02115
Investigative Site US030
Boston, Massachusetts, 02215
Investigative Site US001
Bowling Green, Kentucky, 42104
Investigative Site US045
Boynton Beach, Florida, 33437
Investigative Site US055
Brea, California, 92821
Investigative Site US014
Chapel Hill, North Carolina, 27516
Investigative Site US024
Charleston, South Carolina, 29425
Investigative Site US026
Chicago, Illinois, 60657
Investigative Site US044
Cincinnati, Ohio, 45219
Investigative Site US049
Clarksville, Indiana, 47129
Investigative Site US008
Columbus, Ohio, 43230
Investigative Site US062
Dallas, Texas, 75390
Investigative Site US043
Danville, Pennsylvania, 17822
Investigative Site US035
El Paso, Texas, 79902
Investigative Site US025
Fargo, North Dakota, 58103
Investigative Site US002
Fayetteville, Arkansas, 72703
Investigative Site US028
Fort Myers, Florida, 33912
Investigative Site US032
Frisco, Texas, 75033
Investigative Site US046
Glenn Dale, Maryland, 20769
Investigative Site US004
Laguna Niguel, California, 92677
Investigative Site US040
Layton, Utah, 84041
Investigative Site US007
Los Angeles, California, 90033
Investigative Site US022
Louisville, Kentucky, 40241
Investigative Site US019
Marietta, Georgia, 30060
Investigative Site US031
Mason, Ohio, 45040
Investigative Site US016
Miami, Florida, 33142
Investigative Site US006
Minneapolis, Minnesota, 55455
Investigative Site US037
Murray, Utah, 84107
Investigative Site US041
Myrtle Beach, South Carolina, 29788
Investigative Site US047
Nashville, Tennessee, 37215
Investigative Site US021
New Brighton, Minnesota, 55112
Investigative Site US034
New City, New York, 10956
Investigative Site US018
New York, New York, 10003
Investigative Site US017
New York, New York, 10023
Investigative Site US051
Novi, Michigan, 48377
Investigative Site US039
Ogden, Utah, 84405
Investigative Site US048
Oklahoma City, Oklahoma, 73118
Investigative Site US056
Philadelphia, Pennsylvania, 19107
Investigative Site US020
Phoenix, Arizona, 85008
Investigative Site US012
Plano, Texas, 75025
Investigative Site US010
Quincy, Massachusetts, 02169
Investigative Site US023
Rochester, New York, 14623
Investigative Site US036
Saint Joseph, Missouri, 64506
Investigative Site US011
San Antonio, Texas, 78213
Investigative Site US013
San Diego, California, 92103
Investigative Site US060
San Diego, California, 92120
Investigative Site US038
San Diego, California, 92121
Investigative Site US027
Sanford, Florida, 32771
Investigative Site US033
Scottsdale, Arizona, 85259
Investigative Site US058
Seattle, Washington, 98195
Investigative Site US057
Sweetwater, Florida, 33172
Investigative Site US029
Tampa, Florida, 33609
Investigative Site US054
Tempe, Arizona, 85282
Investigative Site US052
West Lafayette, Indiana, 47906
Canada9 sites
Investigative Site CA004
Calgary, Alberta, T2J 7E1
Investigative Site CA003
Calgary, Alberta, T3E 0B2
Investigative Site CA009
Ottawa, Ontario, K1K 4L2
Investigative Site CA002
Peterborough, Ontario, K9J 5K2
Investigative Site CA001
Richmond Hill, Ontario, L4B 1L1
Investigative Site CA008
Sherbrooke, Quebec, J1G 1X9
Investigative Site CA007
Toronto, Ontario, M3B 0A7
Investigative Site CA005
Toronto, Ontario, M4E 1R7
Investigative Site CA006
Waterloo, Ontario, N2J 1C4
Italy9 sites
Investigative Site IT001
Catania, 95123
Investigative Site IT005
Cona, 44124
Investigative Site IT009
Florence, 50122
Investigative Site IT003
Milan, 20122
Investigative Site IT007
Naples, 80131
Investigative Site IT006
Roma, 00137
Investigative Site IT004
Roma, 00144
Investigative Site IT002
Rozzano, 20089
Investigative Site IT008
Torino, 10126
Germany8 sites
Investigative Site DE006
Berlin, 10117
Investigative Site DE005
Berlin, 13595
Investigative Site DE002
Bochum, 44791
Investigative Site DE004
Darmstadt, 64283
Investigative Site DE001
Dresden, 01307
Investigative Site DE003
Erlangen, 91054
Investigative Site DE007
Hamburg, 20246
Investigative Site DE008
Lübeck, 23538
France5 sites
Investigative Site FR002
Bordeaux, 33000
Investigative Site FR005
Brest, 29609
Investigative Site FR004
Nantes, 44093
Investigative Site FR003
Nice, 06200
Investigative Site FR001
Paris, 75010
Spain5 sites
Investigative Site ES004
Alicante, 03010
Investigative Site ES005
Badalona, 08916
Investigative Site ES003
Barcelona, 08003
Investigative Site ES001
Madrid, 28009
Investigative Site ES002
Madrid, 28040
Poland4 sites
Investigative Site PL002
Lodz, 90-436
Investigative Site PL003
Torun, 87-100
Investigative Site PL001
Warsaw, 02-962
Investigative Site PL004
Wroclaw, 54-239
Bulgaria2 sites
Investigative Site BG002
Sofia, 01407
Investigative Site BG003
Sofia, 01463
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Receives: Drug: Ruxolitinib Cream |
| Vehicle Cream | Placebo comparator | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Proportion of participants with presence of draining tunnels at each postbaseline visit
Participants with presence of draining tunnels.
Measured: Up to 52 weeks
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
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
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
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
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
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
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
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
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
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
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
Percent change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit
he 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
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
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
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
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
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
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
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.
- First posted6 May 2025
- Study start23 Jun 2025
- Primary completion9 Oct 2026 (estimated)
- Study completion11 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Study Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959225
- Sponsor's protocol ID
- INCB018424-324
- Other IDs
- 2024-517632-22-00
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2025
- Last updated
- 28 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06959225
- Acronym / sponsor ID
- INCB018424-324
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, skin disease, ruxolitinb cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 11 Jul 2027 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Drug: Ruxolitinib CreamParticipants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamParticipants received vehicle cream, applied topically to the affected area as defined by the protocol. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib CreamRuxolitinib cream applied topically to the affected area as a thin film twice daily. | Drug | Ruxolitinib 1.5 % Cream |
| Vehicle CreamMatching vehicle cream applied topically to the affected area as a thin film twice daily. | Drug | Vehicle Cream |
Primary outcome
Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
Time frame: Week 16
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.
35 secondary outcomes
Proportion of participants with ≥ 1 flare
Time frame: Up to 16 weeks
Proportion of participants who achieve HiSCR50
Time frame: Week 16
Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3
Time frame: Week 16
Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline
Time frame: Week 16
Treatment-IR Population: Proportion of participants with ≥ 1 HS flare
Time frame: Up to 16 weeks
Treatment-IR Population: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3
Time frame: Week 16
Proportion of participants who achieve HiSCR50/75/90/100 at each postbaseline visit
Time frame: Up to 16 weeks
Extension Period: Proportion of participants with ≥ 1 HS flare
Time frame: From Week 16 through Week 52
Proportion of participants who achieve abscess and/or inflammatory nodule (AN)75 at each postbaseline visit
Time frame: Up to 52 weeks
Mean change from baseline in total AN count at each postbaseline visit
Time frame: Up to 52 weeks
Percentage change from baseline in total AN count at each postbaseline visit
Time frame: Up to 52 weeks
Mean change from baseline in abscess count at each postbaseline visit
Time frame: Up to 52 weeks
Percentage change from baseline in abscess count at each postbaseline visit
Time frame: Up to 52 weeks
Mean change from baseline in inflammatory nodule count at each postbaseline visit
Time frame: Up to 52 weeks
Percentage change from baseline in inflammatory nodule count at each postbaseline visit
Time frame: Up to 52 weeks
Proportion of participants with presence of draining tunnels at each postbaseline visit
Time frame: Up to 52 weeks
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
Time frame: Up to 52 weeks
Proportion of participants who achieve Itch Numeric Rating Scale (NRS)30 among participants with baseline Itch NRS score ≥ 3 at each postbaseline visit
Time frame: Up to 52 weeks
Proportion of participants who achieve Patient Global Impression of Change (PGIC) at each postbaseline visit
Time frame: Up to 52 weeks
Proportion of participants who achieve PGIC score 1 or 2 at each postbaseline visit
Time frame: Up to 52 weeks
Patient Global Impression of Severity (PGIS) score at each postbaseline visit
Time frame: Up to 52 weeks
Change from baseline in PGIS Score at each postbaseline visit
Time frame: Up to 52 weeks
Proportion of participants who achieve status of Dermatology Life Quality Index (DLQ1)4 at each postbaseline visit
Time frame: Up to 52 weeks
Proportion of participants who achieve status of Children's Dermatology Life Quality Index (CDLQ1)6 at each postbaseline visit
Time frame: Up to 52 weeks
Change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit
Time frame: Up to 52 weeks
Percent change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit
Time frame: Up to 52 weeks
Change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit
Time frame: Up to 52 weeks
Percent change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit
Time frame: Up to 52 weeks
Change from baseline in EuroQol 5-dimension 5-level scale (EQ-5D-5L) score at each postbaseline visit
Time frame: Up to 52 weeks
Treatment-IR Population: Change from baseline in total abscess count at each postbaseline visit
Time frame: Up to 52 weeks
Treatment-IR Population: Percent change from baseline in total abscess count at each postbaseline visit
Time frame: Up to 52 weeks
Treatment-IR Population: Change from baseline in total inflammatory nodule count at each postbaseline visit
Time frame: Up to 52 weeks
Treatment-IR Population: Percent change from baseline in total inflammatory nodule count at each postbaseline visit
Time frame: Up to 52 weeks
Treatment-IR Population: Proportion of participants with presence of draining tunnels at each postbaseline visit
Time frame: Up to 52 weeks
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 56 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Study Monitor study director
Incyte Corporation
101 sites in 8 countries: see every site and its status.
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 101 sites in 8 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 28 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 101 sites in United States, Canada, Italy, Germany, France and 3 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?
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 28 Jul 2026.