A Phase 2 interventional study of Ruxolitinib cream and Vehicle cream in Lichen Sclerosus, sponsored by Incyte Corporation. Completed at 14 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
48 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 10 are open to participants now.
This study's enrollment of 61 is above the median of 40 across 36 interventional studies indexed under Lichen Sclerosus et Atrophicus.
Browse Lichen Sclerosus et Atrophicus studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Concurrent conditions and history of other diseases:
Ruxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Drug: Ruxolitinib cream · Drug: Vehicle cream
Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension.
Drug: Vehicle cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Also known as: INCB018424 cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Percentage of Participants With ITCH4 at Week 12
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: Baseline; Week 12
Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12
The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible \[i.e., itch, pain, dysuria\]); signs (3 items; possibly reversible \[i.e., whitening, petechiae/ecchymosis, fissures\]); and architectural changes (6 items; irreversible \[i.e., skin fusion, perianal involvement, etc.\]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section.
Time frame: Baseline; Week 12
Change From Baseline in the Skin Pain NRS Score at Week 12
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours.
Time frame: Baseline; Week 12
Time to Achieve ITCH4
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: up to 99.0 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled 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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Baseline to Week 12 plus 30 days
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
A TEAE was defined as an AE either 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 the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 Baseline to Week 12 plus 30 days
Number of Participants With Any TEAE During the Open-label Extension 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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Week 12 to Week 24 plus 30 days
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
A TEAE was defined as an AE either 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 the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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 12 to Week 24 plus 30 days
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Baseline to Week 12 plus 30 days
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Baseline to Week 12 plus 30 days
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Week 12 to Week 24 plus 30 days
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Week 12 to Week 24 plus 30 days
| Milestone | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|---|---|
| Started | 31 | 30 | 0 | 0 |
| Completed | 29 | 27 | 0 | 0 |
| Not completed | 2 | 3 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Did not meet eligibility criteria | 1 | 0 | 0 | 0 |
| Milestone | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|---|---|
| Started | 0 | 0 | 29 | 27 |
| Completed | 0 | 0 | 26 | 25 |
| Not completed | 0 | 0 | 3 | 2 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
| percentage of participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Percentage of Participants With ITCH4 at Week 12 | 35.7 (18.6 to 55.9) | 40.0 (22.7 to 59.4) |
The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible \[i.e., itch, pain, dysuria\]); signs (3 items; possibly reversible \[i.e., whitening, petechiae/ecchymosis, fissures\]); and architectural changes (6 items; irreversible \[i.e., skin fusion, perianal involvement, etc.\]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section.
| scores on a scale | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | -5.79 ± 0.80 | -3.03 ± 0.82 |
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours.
| scores on a scale | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Change From Baseline in the Skin Pain NRS Score at Week 12 | -3.22 ± 0.50 | -2.70 ± 0.52 |
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
| days | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Time to Achieve ITCH4 | 35.0 (7.0 to 57.0) | 28.0 (6.0 to NA) |
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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | 14 | 12 |
A TEAE was defined as an AE either 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 the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | 1 | 0 |
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 an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any TEAE During the Open-label Extension Period | 13 | 11 |
A TEAE was defined as an AE either 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 the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: 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.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | 1 | 0 |
The investigator determined if a clinical laboratory test value was clinically meaningful.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | 0 | 0 |
The investigator determined if a clinical laboratory test value was clinically meaningful.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | 0 | 0 |
The investigator determined if a clinical laboratory test value was clinically meaningful.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | 0 | 0 |
The investigator determined if a clinical laboratory test value was clinically meaningful.
| Participants | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | 0 | 0 |
Collected over up to approximately 32 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ruxolitinib Cream 1.5% BID | 0/58 (0%) | 0/58 (0%) | 10/58 (17.2%) |
| Vehicle Cream BID | 0/30 (0%) | 1/30 (3.3%) | 6/30 (20%) |
| Event | Ruxolitinib Cream 1.5% BID | Vehicle Cream BID |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 0/58 | 1/30 |
| Event | Ruxolitinib Cream 1.5% BID | Vehicle Cream BID |
|---|---|---|
| NasopharyngitisInfections and infestations | 3/58 | 3/30 |
| Urinary tract infectionInfections and infestations | 4/58 | 0/30 |
| COVID-19Infections and infestations | 2/58 | 2/30 |
| Upper respiratory tract infectionInfections and infestations | 1/58 | 2/30 |
| Vulvovaginal mycotic infectionInfections and infestations | 3/58 | 0/30 |
| Age, Continuous(years) | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID | Total |
|---|---|---|---|
| Mean | 60.0 ± 11.28 | 61.9 ± 12.25 | 60.9 ± 11.71 |
| Sex: Female, Male(Participants) | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID | Total |
|---|---|---|---|
| Female | 31 | 30 | 61 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 28 | 25 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DBVC Period: Ruxolitinib Cream 1.5% BID | DBVC Period: Vehicle Cream BID | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 5 | 5 |
| White | 31 | 25 | 56 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lichen Sclerosus et Atrophicus→
Incyte Corporation