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

• Ruxolitinib Cream (Drug): Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
• Vehicle Cream (Drug): Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Primary outcomes

• Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline [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.

Secondary outcomes

• Proportion of participants with ≥ 1 flare [Up to 16 weeks]: Defined as a ≥ 25% increase in AN count with a minimum increase in total AN count of 2 relative to baseline.
• Proportion of participants who achieve HiSCR50 [Week 16]: Defined as a ≥ 50 reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.
• Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3 [Week 16]: 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.
• Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline [Week 16]: 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.
• Treatment-IR Population: Proportion of participants with ≥ 1 HS flare [Up to 16 weeks]: Defined as a ≥ 25% increase in total AN count with a minimum increase in AN count of 2 relative to baseline.
• Treatment-IR Population: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3 [Week 16]: 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.
• Proportion of participants who achieve HiSCR50/75/90/100 at each postbaseline visit [Up to 16 weeks]: 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.
• Extension Period: Proportion of participants with ≥ 1 HS flare [From Week 16 through Week 52]: Defined as a ≥ 25% increase in total AN count with a minimum increase in AN count of 2 relative to baseline.
• Proportion of participants who achieve abscess and/or inflammatory nodule (AN)75 at each postbaseline visit [Up to 52 weeks]: Defined as a ≥ 75% reduction from baseline in total AN count.
• Mean change from baseline in total AN count at each postbaseline visit [Up to 52 weeks]: Defined as mean change in total AN count.
• Percentage change from baseline in total AN count at each postbaseline visit [Up to 52 weeks]: Defined as percent change from baseline in total AN count.
• Mean change from baseline in abscess count at each postbaseline visit [Up to 52 weeks]: Defined as mean change of abscess(es) count relative to baseline.
• Percentage change from baseline in abscess count at each postbaseline visit [Up to 52 weeks]: Percent Change from baseline in number of abscess(es).
• Mean change from baseline in inflammatory nodule count at each postbaseline visit [Up to 52 weeks]: Defined as mean change of inflammatory nodule count relative to baseline.
• Percentage change from baseline in inflammatory nodule count at each postbaseline visit [Up to 52 weeks]: Defined as percent change from baseline in number of inflammatory nodule(s).
• Proportion of participants with presence of draining tunnels at each postbaseline visit [Up to 52 weeks]: Participants with presence of draining tunnels.
• 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 [Up to 52 weeks]: 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.
• Proportion of participants who achieve Itch Numeric Rating Scale (NRS)30 among participants with baseline Itch NRS score ≥ 3 at each postbaseline visit [Up to 52 weeks]: 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.
• Proportion of participants who achieve Patient Global Impression of Change (PGIC) at each postbaseline visit [Up to 52 weeks]: 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.
• Proportion of participants who achieve PGIC score 1 or 2 at each postbaseline visit [Up to 52 weeks]: 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.
• Patient Global Impression of Severity (PGIS) score at each postbaseline visit [Up to 52 weeks]: 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.
• Change from baseline in PGIS Score at each postbaseline visit [Up to 52 weeks]: 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.
• Proportion of participants who achieve status of Dermatology Life Quality Index (DLQ1)4 at each postbaseline visit [Up to 52 weeks]: 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.
• Proportion of participants who achieve status of Children's Dermatology Life Quality Index (CDLQ1)6 at each postbaseline visit [Up to 52 weeks]: 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.
• Change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit [Up to 52 weeks]: 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.
• Percent change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit [Up to 52 weeks]: 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.
• Change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit [Up to 52 weeks]: 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.
• Percent change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit [Up to 52 weeks]: 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.
• Change from baseline in EuroQol 5-dimension 5-level scale (EQ-5D-5L) score at each postbaseline visit [Up to 52 weeks]: The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.
• Treatment-IR Population: Change from baseline in total abscess count at each postbaseline visit [Up to 52 weeks]: Defined as change from baseline in total abscess count.
• Treatment-IR Population: Percent change from baseline in total abscess count at each postbaseline visit [Up to 52 weeks]: Percent Change from baseline in total abscess count.
• Treatment-IR Population: Change from baseline in total inflammatory nodule count at each postbaseline visit [Up to 52 weeks]: Defined as change from baseline in total number of inflammatory nodule(s).
• Treatment-IR Population: Percent change from baseline in total inflammatory nodule count at each postbaseline visit [Up to 52 weeks]: Defined as percent change from baseline in number of inflammatory nodule(s).
• Treatment-IR Population: Proportion of participants with presence of draining tunnels at each postbaseline visit [Up to 52 weeks]: Participants with presence of draining tunnels.
• Number of Treatment Emergent Adverse Events (TEAEs) [Up to 56 weeks]: 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.

Sex: All, ages: 12 Years to any

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:

  * 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.

Exclusion Criteria:

* 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.

7 more sites not listed.

• Incyte Study Monitor, Study director, Incyte Corporation