Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Drug: Vehicle Cream
- Registration Number
- NCT06958211
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 450
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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.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ruxolitinib 1.5 % Cream Ruxolitinib Cream Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Vehicle Cream Vehicle Cream Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of participants with ≥ 1 flare Up to 16 weeks Defined as ≥ 25% increase in AN count with a minimum increase in total AN count of 2 relative to baseline.
Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 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 NRS30, defined as at least a 30% reduction and at least 1-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 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.
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 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 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 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.
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: Proportion of participants with ≥ 1 HS flare Up to 16 weeks Defined as ≥ 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)30 at Week 12 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 NRS30, defined as at least a 30% reduction and at least 1-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 ≥ 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 ≥ 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 ≥ 75% reduction from baseline in total AN count.
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.
Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 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 NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.
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 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.
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.
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.