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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517632-22-00 | Registry Identifier | EU CT Number |
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The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
|
| Vehicle Cream | Placebo Comparator | Participants received vehicle cream, applied topically to the affected area as defined by the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Cream | Drug | Ruxolitinib cream applied topically to the affected area as a thin film twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 16 weeks |
| Proportion of participants who achieve HiSCR50 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Study Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site US020 | Recruiting | Phoenix | Arizona | 85008 | United States | |
| Investigative Site US033 |
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| Label | URL |
|---|---|
| Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1) | View source |
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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
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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| Vehicle Cream | Drug | Matching vehicle cream applied topically to the affected area as a thin film twice daily. |
|
Defined as a ≥ 50 reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 52 weeks |
| Mean change from baseline in total AN count at each postbaseline visit | Defined as mean change in total AN count. | 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. | 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. | Up to 52 weeks |
| Percentage change from baseline in abscess count at each postbaseline visit | Percent Change from baseline in number of abscess(es). | 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. | 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). | Up to 52 weeks |
| Proportion of participants with presence of draining tunnels at each postbaseline visit | Participants with presence of draining tunnels. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | Up to 56 weeks |
| Recruiting |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Investigative Site US054 | Recruiting | Tempe | Arizona | 85282 | United States |
| Investigative Site US002 | Recruiting | Fayetteville | Arkansas | 72703 | United States |
| Investigative Site US055 | Recruiting | Brea | California | 92821 | United States |
| Investigative Site US004 | Recruiting | Laguna Niguel | California | 92677 | United States |
| Investigative Site US007 | Recruiting | Los Angeles | California | 90033 | United States |
| Investigative Site US013 | Recruiting | San Diego | California | 92103 | United States |
| Investigative Site US060 | Recruiting | San Diego | California | 92120 | United States |
| Investigative Site US038 | Recruiting | San Diego | California | 92121 | United States |
| Investigative Site US059 | Recruiting | Aurora | Colorado | 80045 | United States |
| Investigative Site US045 | Recruiting | Boynton Beach | Florida | 33437 | United States |
| Investigative Site US028 | Recruiting | Fort Myers | Florida | 33912 | United States |
| Investigative Site US016 | Recruiting | Miami | Florida | 33142 | United States |
| Investigative Site US027 | Recruiting | Sanford | Florida | 32771 | United States |
| Investigative Site US057 | Recruiting | Sweetwater | Florida | 33172 | United States |
| Investigative Site US029 | Recruiting | Tampa | Florida | 33609 | United States |
| Investigative Site US061 | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
| Investigative Site US053 | Recruiting | Atlanta | Georgia | 30331 | United States |
| Investigative Site US019 | Recruiting | Marietta | Georgia | 30060 | United States |
| Investigative Site US026 | Recruiting | Chicago | Illinois | 60657 | United States |
| Investigative Site US049 | Recruiting | Clarksville | Indiana | 47129 | United States |
| Investigative Site US052 | Recruiting | West Lafayette | Indiana | 47906 | United States |
| Investigative Site US001 | Recruiting | Bowling Green | Kentucky | 42104 | United States |
| Investigative Site US022 | Recruiting | Louisville | Kentucky | 40241 | United States |
| Investigative Site US050 | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| Investigative Site US046 | Recruiting | Glenn Dale | Maryland | 20769 | United States |
| Investigative Site US003 | Recruiting | Boston | Massachusetts | 02115 | United States |
| Investigative Site US030 | Recruiting | Boston | Massachusetts | 02215 | United States |
| Investigative Site US010 | Recruiting | Quincy | Massachusetts | 02169 | United States |
| Investigative Site US051 | Not yet recruiting | Novi | Michigan | 48377 | United States |
| Investigative Site US006 | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| Investigative Site US021 | Recruiting | New Brighton | Minnesota | 55112 | United States |
| Investigative Site US036 | Recruiting | Saint Joseph | Missouri | 64506 | United States |
| Investigative Site US034 | Recruiting | New City | New York | 10956 | United States |
| Investigative Site US018 | Recruiting | New York | New York | 10003 | United States |
| Investigative Site US017 | Recruiting | New York | New York | 10023 | United States |
| Investigative Site US023 | Recruiting | Rochester | New York | 14623 | United States |
| Investigative Site US014 | Recruiting | Chapel Hill | North Carolina | 27516 | United States |
| Investigative Site US025 | Recruiting | Fargo | North Dakota | 58103 | United States |
| Investigative Site US015 | Recruiting | Bexley | Ohio | 43209 | United States |
| Investigative Site US044 | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Investigative Site US008 | Recruiting | Columbus | Ohio | 43230 | United States |
| Investigative Site US031 | Recruiting | Mason | Ohio | 45040 | United States |
| Investigative Site US048 | Recruiting | Oklahoma City | Oklahoma | 73118 | United States |
| Investigative Site US043 | Not yet recruiting | Danville | Pennsylvania | 17822 | United States |
| Investigative Site US056 | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Investigative Site US024 | Recruiting | Charleston | South Carolina | 29425 | United States |
| Investigative Site US041 | Recruiting | Myrtle Beach | South Carolina | 29788 | United States |
| Investigative Site US047 | Recruiting | Nashville | Tennessee | 37215 | United States |
| Investigative Site US062 | Recruiting | Dallas | Texas | 75390 | United States |
| Investigative Site US035 | Recruiting | El Paso | Texas | 79902 | United States |
| Investigative Site US032 | Recruiting | Frisco | Texas | 75033 | United States |
| Investigative Site US012 | Recruiting | Plano | Texas | 75025 | United States |
| Investigative Site US011 | Recruiting | San Antonio | Texas | 78213 | United States |
| Investigative Site US040 | Completed | Layton | Utah | 84041 | United States |
| Investigative Site US037 | Recruiting | Murray | Utah | 84107 | United States |
| Investigative Site US039 | Completed | Ogden | Utah | 84405 | United States |
| Investigative Site US058 | Recruiting | Seattle | Washington | 98195 | United States |
| Investigative Site BG002 | Recruiting | Sofia | 01407 | Bulgaria |
| Investigative Site BG003 | Recruiting | Sofia | 01463 | Bulgaria |
| Investigative Site CA004 | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Investigative Site CA003 | Recruiting | Calgary | Alberta | T3E 0B2 | Canada |
| Investigative Site CA009 | Recruiting | Ottawa | Ontario | K1K 4L2 | Canada |
| Investigative Site CA002 | Recruiting | Peterborough | Ontario | K9J 5K2 | Canada |
| Investigative Site CA001 | Recruiting | Richmond Hill | Ontario | L4B 1L1 | Canada |
| Investigative Site CA007 | Recruiting | Toronto | Ontario | M3B 0A7 | Canada |
| Investigative Site CA005 | Recruiting | Toronto | Ontario | M4E 1R7 | Canada |
| Investigative Site CA006 | Recruiting | Waterloo | Ontario | N2J 1C4 | Canada |
| Investigative Site CA008 | Recruiting | Sherbrooke | Quebec | J1G 1X9 | Canada |
| Investigative Site FR002 | Recruiting | Bordeaux | 33000 | France |
| Investigative Site FR005 | Recruiting | Brest | 29609 | France |
| Investigative Site FR004 | Recruiting | Nantes | 44093 | France |
| Investigative Site FR003 | Recruiting | Nice | 06200 | France |
| Investigative Site FR001 | Recruiting | Paris | 75010 | France |
| Investigative Site DE006 | Recruiting | Berlin | 10117 | Germany |
| Investigative Site DE005 | Recruiting | Berlin | 13595 | Germany |
| Investigative Site DE002 | Recruiting | Bochum | 44791 | Germany |
| Investigative Site DE004 | Recruiting | Darmstadt | 64283 | Germany |
| Investigative Site DE001 | Recruiting | Dresden | 01307 | Germany |
| Investigative Site DE003 | Recruiting | Erlangen | 91054 | Germany |
| Investigative Site DE007 | Recruiting | Hamburg | 20246 | Germany |
| Investigative Site DE008 | Recruiting | Lübeck | 23538 | Germany |
| Investigative Site IT001 | Recruiting | Catania | 95123 | Italy |
| Investigative Site IT005 | Recruiting | Cona | 44124 | Italy |
| Investigative Site IT009 | Not yet recruiting | Florence | 50122 | Italy |
| Investigative Site IT003 | Recruiting | Milan | 20122 | Italy |
| Investigative Site IT007 | Recruiting | Naples | 80131 | Italy |
| Investigative Site IT006 | Recruiting | Roma | 00137 | Italy |
| Investigative Site IT004 | Recruiting | Roma | 00144 | Italy |
| Investigative Site IT002 | Recruiting | Rozzano | 20089 | Italy |
| Investigative Site IT008 | Not yet recruiting | Torino | 10126 | Italy |
| Investigative Site PL002 | Recruiting | Lodz | 90-436 | Poland |
| Investigative Site PL003 | Recruiting | Torun | 87-100 | Poland |
| Investigative Site PL001 | Recruiting | Warsaw | 02-962 | Poland |
| Investigative Site PL004 | Recruiting | Wroclaw | 54-239 | Poland |
| Investigative Site ES004 | Recruiting | Alicante | 03010 | Spain |
| Investigative Site ES005 | Recruiting | Badalona | 08916 | Spain |
| Investigative Site ES003 | Recruiting | Barcelona | 08003 | Spain |
| Investigative Site ES001 | Recruiting | Madrid | 28009 | Spain |
| Investigative Site ES002 | Recruiting | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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