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

Phase 3RecruitingNCT06958211

Incyte Corporation450 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Hidradenitis Suppurativa

Interventions

Ruxolitinib CreamDRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Vehicle CreamDRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (110)

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

Proportion of participants with ≥ 1 flare

Defined as ≥ 25% increase in AN count with a minimum increase in total AN count of 2 relative to baseline.

Time frame: Up to 16 weeks

Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 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 NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

Time frame: 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.

Time frame: Week 16

Treatment-IR Population: Proportion of participants with ≥ 1 HS flare

Defined as ≥ 25% increase in total AN count with a minimum increase in AN count of 2 relative to baseline.

Time frame: Up to 16 weeks

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

Central Contacts

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

Data from ClinicalTrials.gov

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Investigative Site US257

Birmingham, Alabama, United States

RECRUITING

Investigative Site US218

Birmingham, Alabama, United States

RECRUITING

Investigative Site US239

Montgomery, Alabama, United States

RECRUITING

Investigative Site US215

Phoenix, Arizona, United States

RECRUITING

Investigative Site US261

Phoenix, Arizona, United States

RECRUITING

Investigative Site US221

Scottsdale, Arizona, United States

WITHDRAWN

Investigative Site US240

Tucson, Arizona, United States

NOT_YET_RECRUITING

Investigative Site US262

Encino, California, United States

RECRUITING

Investigative Site US222

Fountain Valley, California, United States

RECRUITING

Investigative Site US211

Los Angeles, California, United States

RECRUITING

...and 100 more locations

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

Defined as ≥ 50%/75%/90%/100% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count.

Time frame: Up to 16 weeks

Extension Period: Proportion of participants with ≥ 1 HS flare

Defined as ≥ 25% increase in total AN count with a minimum increase in AN count of 2 relative to baseline.

Time frame: From Week 16 through Week 52

Proportion of participants who achieve abscess and/or inflammatory nodule (AN)75 at each postbaseline visit

Defined as ≥ 75% reduction from baseline in total AN count.

Time frame: Up to 52 weeks

Mean change from baseline in total AN count at each postbaseline visit

Defined as mean change in total AN count.

Time frame: 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.

Time frame: 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.

Time frame: Up to 52 weeks

Percentage change from baseline in abscess count at each postbaseline visit

Percent Change from baseline in number of abscess(es).

Time frame: 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.

Time frame: 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).

Time frame: Up to 52 weeks

Proportion of participants with presence of draining tunnels at each postbaseline visit

Participants with presence of draining tunnels.

Time frame: Up to 52 weeks

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

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 52 weeks

Proportion of participants who achieve PGIC score 1 or 2 at each postbaseline visit

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: Up to 56 weeks