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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517633-40-00 | 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 | Affiliation | Role |
|---|---|---|
| Incyte Study Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site US257 | Birmingham | Alabama | 35203 | United States | ||
| Investigative Site US218 |
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| Label | URL |
|---|---|
| Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2) | 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 | 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 |
| 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 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Investigative Site US239 | Montgomery | Alabama | 36117 | United States |
| Investigative Site US215 | Phoenix | Arizona | 85006 | United States |
| Investigative Site US261 | Phoenix | Arizona | 85037 | United States |
| Investigative Site US240 | Tucson | Arizona | 85718 | United States |
| Investigative Site US262 | Encino | California | 91436 | United States |
| Investigative Site US222 | Fountain Valley | California | 92708 | United States |
| Investigative Site US211 | Los Angeles | California | 90045 | United States |
| Investigative Site US237 | Los Angeles | California | 90056 | United States |
| Investigative Site US234 | Northridge | California | 91325 | United States |
| Investigative Site US250 | Santa Ana | California | 92706 | United States |
| Investigative Site US244 | Castle Rock | Colorado | 80109 | United States |
| Investigative Site US252 | Cromwell | Connecticut | 06416 | United States |
| Investigative Site US208 | Boca Raton | Florida | 33486 | United States |
| Investigative Site US203 | Hialeah | Florida | 33012-3618 | United States |
| Investigative Site US258 | Jacksonville | Florida | 32216 | United States |
| Investigative Site US206 | Maitland | Florida | 32751 | United States |
| Investigative Site US223 | Miami | Florida | 33136 | United States |
| Investigative Site US241 | Miami | Florida | 33147 | United States |
| Investigative Site US202 | Miami | Florida | 33173 | United States |
| Investigative Site US214 | Tampa | Florida | 33609 | United States |
| Investigative Site US247 | Tampa | Florida | 33612 | United States |
| Investigative Site US231 | Columbus | Georgia | 31904 | United States |
| Investigative Site US225 | Sandy Springs | Georgia | 30328 | United States |
| Investigative Site US207 | Skokie | Illinois | 60077 | United States |
| Investigative Site US205 | Plainfield | Indiana | 46168 | United States |
| Investigative Site US264 | Lake Charles | Louisiana | 70601 | United States |
| Investigative Site US266 | New Orleans | Louisiana | 70115 | United States |
| Investigative Site US254 | Gambrills | Maryland | 21054 | United States |
| Investigative Site US201 | Marriottsville | Maryland | 21104 | United States |
| Investigative Site US253 | Milford | Massachusetts | 01757 | United States |
| Investigative Site US227 | Needham | Massachusetts | 02492 | United States |
| Investigative Site US268 | Worcester | Massachusetts | 01605 | United States |
| Investigative Site US238 | Ann Arbor | Michigan | 48103 | United States |
| Investigative Site US230 | Auburn Hills | Michigan | 48326 | United States |
| Investigative Site US251 | St Louis | Missouri | 63110-1010 | United States |
| Investigative Site US271 | Wildwood | Missouri | 63040 | United States |
| Investigative Site US212 | Missoula | Montana | 59804 | United States |
| Investigative Site US216 | Las Vegas | Nevada | 89145 | United States |
| Investigative Site US235 | Hoboken | New Jersey | 07030 | United States |
| Investigative Site US217 | Albuquerque | New Mexico | 87102 | United States |
| Investigative Site US219 | Brooklyn | New York | 11203 | United States |
| Investigative Site US246 | Elmhurst | New York | 11373 | United States |
| Investigative Site US269 | Fairport | New York | 14450 | United States |
| Investigative Site US213 | Kew Gardens | New York | 11415 | United States |
| Investigative Site US242 | New York | New York | 10075 | United States |
| Investigative Site US245 | Rochester | New York | 14620 | United States |
| Investigative Site US259 | Huntersville | North Carolina | 28078 | United States |
| Investigative Site US263 | Winston-Salem | North Carolina | 27104 | United States |
| Investigative Site US228 | Cleveland | Ohio | 44124 | United States |
| Investigative Site US243 | Columbus | Ohio | 43213 | United States |
| Investigative Site US249 | Columbus | Ohio | 43213 | United States |
| Investigative Site US204 | Portland | Oregon | 97201 | United States |
| Investigative Site US226 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Investigative Site US256 | Bluffton | South Carolina | 29910 | United States |
| Investigative Site US267 | Mt. Pleasant | South Carolina | 29464 | United States |
| Investigative Site US255 | Austin | Texas | 78759 | United States |
| Investigative Site US260 | Cypress | Texas | 77429 | United States |
| Investigative Site US270 | Prosper | Texas | 75078 | United States |
| Investigative Site US232 | Sugar Land | Texas | 77479 | United States |
| Investigative Site US248 | Arlington | Virginia | 22206 | United States |
| Investigative Site US209 | Danville | Virginia | 24541 | United States |
| Investigative Site US229 | Norfolk | Virginia | 23502 | United States |
| Investigative Site US265 | Seattle | Washington | 98105 | United States |
| Investigative Site US224 | Spokane | Washington | 99202 | United States |
| Investigative Site US210 | Milwaukee | Wisconsin | 53226 | United States |
| Investigative Site BE204 | Brussels | 01070 | Belgium |
| Investigative Site BE201 | Ghent | 09000 | Belgium |
| Investigative Site BE203 | Ghent | 09000 | Belgium |
| Investigative Site BE202 | Leuven | 03000 | Belgium |
| Investigative Site BG201 | Sevlievo | 05400 | Bulgaria |
| Investigative Site BG202 | Sofia | 01431 | Bulgaria |
| Investigative Site BG203 | Sofia | 01592 | Bulgaria |
| Investigative Site CA209 | Edmonton | Alberta | T5K1X3 | Canada |
| Investigative Site CA201 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigative Site CA207 | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Investigative Site CA202 | Hamilton | Ontario | L8L 3C3 | Canada |
| Investigative Site CA203 | London | Ontario | N6H 5L5 | Canada |
| Investigative Site CA204 | Markham | Ontario | L3P 1X3 | Canada |
| Investigative Site CA205 | Mississauga | Ontario | L4W 0C2 | Canada |
| Investigative Site CA208 | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Investigative Site CA206 | St. John's | A1E 1V4 | Canada |
| Investigative Site FR201 | Reims | 51100 | France |
| Investigative Site FR203 | Rouen | 76031 | France |
| Investigative Site FR204 | Saint-Etienne | 42055 | France |
| Investigative Site FR202 | Toulouse | 31059 | France |
| Investigative Site DE207 | Bad Bentheim | 48455 | Germany |
| Investigative Site DE206 | Göttingen | 37075 | Germany |
| Investigative Site DE202 | Hanover | 30159 | Germany |
| Investigative Site DE203 | Kiel | 24105 | Germany |
| Investigative Site DE205 | Langenau | 89129 | Germany |
| Investigative Site DE204 | Merzig | 66663 | Germany |
| Investigative Site NL203 | Amsterdam | 1105 AZ | Netherlands |
| Investigative Site NL201 | Rotterdam | 3015 CE | Netherlands |
| Investigative Site PL202 | Lublin | 20-607 | Poland |
| Investigative Site LP204 | Poznan | 60-309 | Poland |
| Investigative Site PL201 | Rzeszów | 35-055 | Poland |
| Investigative Site PL203 | Wroclaw | 54-144 | Poland |
| Investigative Site ES205 | Barcelona | 08041 | Spain |
| Investigative Site ES208 | Esplugues de Llobregat | 08950 | Spain |
| Investigative Site ES201 | Granada | 18014 | Spain |
| Investigative Site ES206 | Granollers | 08402 | Spain |
| Investigative Site ES202 | Las Palmas de Gran Canaria | 35010 | Spain |
| Investigative Site ES203 | Madrid | 28041 | Spain |
| Investigative Site ES207 | Manises | 46940 | Spain |
| Investigative Site ES204 | Santiago de Compostela | 15706 | 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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