Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis suppurativa, skin disease, ruxolitinb cream
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.
Interventions
DRUGRuxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
DRUGVehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HS based on clinical history and physical examination for at least 3 months. * Diagnosis of HS (Hurley I or II) with the following: 1. A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND 2. The AN count at the screening AND baseline visits: * AN of 3 should affect at least 1 distinct anatomical area * AN of \> 3 to ≤ 10 should affect at least 2 distinct anatomical areas. * Baseline Skin Pain or Itch NRS score ≥ 1. * Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study. * Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study. * Willingness to avoid pregnancy or fathering children
Exclusion criteria
* Presence of draining tunnels at screening or at baseline visits. * Concurrent conditions and history of other diseases: 1. Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS. 2. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety. 3. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome). 4. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. 5. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline. * Laboratory values outside of the protocol-defined criteria. * Use of any prohibited medications per protocol-defined criteria. * Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | Baseline; Week 16 | The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline | Baseline; Week 16 | Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
| Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | Baseline; Week 16 | The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
| Change From Baseline in Itch NRS Score at Week 16 | Baseline; Week 16 | The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
| Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | Baseline; Week 16 | HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline. |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | Baseline; Week 16 | AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | up to Week 16 plus 30 days | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. |
| Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | up to Week 16 plus 30 days | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
| Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | from Week 17 up to Week 32 plus 30 days | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. |
| Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period | from Week 17 up to Week 32 plus 30 days | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
| Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | Baseline; Week 16 | The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
Countries
Canada, United States
Participant flow
Pre-assignment details
This study was conducted at 19 study centers in Canada and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks. | 34 |
| DBVC Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 16 weeks. | 35 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 16-Week DBVC Period | Adverse Event | 2 | 0 | 0 | 0 |
| 16-Week DBVC Period | Developed Draining Fistula | 0 | 1 | 0 | 0 |
| 16-Week DBVC Period | Lost to Follow-up | 5 | 1 | 0 | 0 |
| 16-Week DBVC Period | Physician Decision | 0 | 1 | 0 | 0 |
| 16-Week DBVC Period | Presence of Disease Tunnel | 1 | 0 | 0 | 0 |
| 16-Week DBVC Period | Protocol Violation | 1 | 0 | 0 | 0 |
| 16-Week DBVC Period | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| 16-Week OLE Period | Adverse Event | 0 | 0 | 0 | 2 |
| 16-Week OLE Period | Lost to Follow-up | 0 | 0 | 1 | 3 |
| 16-Week OLE Period | Physician Decision | 0 | 0 | 0 | 1 |
| 16-Week OLE Period | Pregnancy | 0 | 0 | 1 | 0 |
| 16-Week OLE Period | Protocol Violation | 0 | 0 | 1 | 1 |
| 16-Week OLE Period | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | DBVC Period: Vehicle Cream BID | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 9.76 | 31.3 years STANDARD_DEVIATION 9.84 | 32.0 years STANDARD_DEVIATION 9.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 34 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African-American | 29 Participants | 18 Participants | 11 Participants |
| Race/Ethnicity, Customized Half White, Half Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Metis, White | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Mixed Race: Black and White | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized North African | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White and American Indian/Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 31 Participants | 12 Participants | 19 Participants |
| Sex: Female, Male Female | 62 Participants | 33 Participants | 29 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 66 |
| other Total, other adverse events | 2 / 35 | 5 / 66 |
| serious Total, serious adverse events | 1 / 35 | 2 / 66 |
Outcome results
Primary
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Time frame: Baseline; Week 16
Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to treatment assignment at randomization. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | -3.61 ANs | Standard Error 0.378 |
| DBVC Period: Vehicle Cream BID | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | -2.42 ANs | Standard Error 0.336 |
p-value: 0.021595% CI: [-2.21, -0.18]ANCOVA
Secondary
Change From Baseline in Itch NRS Score at Week 16
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Time frame: Baseline; Week 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Change From Baseline in Itch NRS Score at Week 16 | -1.45 scores on a scale | Standard Error 0.538 |
| DBVC Period: Vehicle Cream BID | Change From Baseline in Itch NRS Score at Week 16 | -2.39 scores on a scale | Standard Error 0.493 |
p-value: 0.203195% CI: [-0.52, 2.4]ANCOVA
Secondary
Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16
The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Time frame: Baseline; Week 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | -1.90 scores on a scale | Standard Error 0.532 |
| DBVC Period: Vehicle Cream BID | Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | -2.09 scores on a scale | Standard Error 0.497 |
p-value: 0.798295% CI: [-1.27, 1.64]ANCOVA
Secondary
Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Time frame: Baseline; Week 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | -3.58 scores on a scale | Standard Error 0.505 |
| DBVC Period: Vehicle Cream BID | Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | -2.76 scores on a scale | Standard Error 0.459 |
p-value: 0.238795% CI: [-2.2, 0.56]ANCOVA
Secondary
Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline
Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Time frame: Baseline; Week 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline | -3.85 ANs | Standard Error 0.362 |
| DBVC Period: Vehicle Cream BID | Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline | -3.17 ANs | Standard Error 0.323 |
p-value: 0.167195% CI: [-1.65, 0.29]ANCOVA
Secondary
Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: up to Week 16 plus 30 days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | 0 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | 2 Participants |
Secondary
Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Week 17 up to Week 32 plus 30 days
Population: Open-label Extension Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period | 0 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period | 3 Participants |
Secondary
Number of Participants With Any TEAE in the Open-label Extension (OLE) Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Week 17 up to Week 32 plus 30 days
Population: Open-label Extension Safety Population: all participants who applied ruxolitinib 1.5% cream BID at least once during the OLE Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | 8 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | 15 Participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: up to Week 16 plus 30 days
Population: Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | 13 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | 15 Participants |
Secondary
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16
AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline.
Time frame: Baseline; Week 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN90 | 20.8 percentage of participants |
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN100 | 20.8 percentage of participants |
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN50 | 79.2 percentage of participants |
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN75 | 54.2 percentage of participants |
| DBVC Period: Vehicle Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN75 | 25.0 percentage of participants |
| DBVC Period: Vehicle Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN90 | 12.5 percentage of participants |
| DBVC Period: Vehicle Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN50 | 56.3 percentage of participants |
| DBVC Period: Vehicle Cream BID | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | AN100 | 12.5 percentage of participants |
Secondary
Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline.
Time frame: Baseline; Week 16
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 79.2 percentage of participants |
| DBVC Period: Vehicle Cream BID | Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 50.0 percentage of participants |