Lichen SclerosusPhase 2NCT05593445
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
A Phase 2 study testing Ruxolitinib cream in people with Lichen Sclerosus, run by Incyte Corporation at 14 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus
- What is being tested?
- Ruxolitinib cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 18 Nov 2022to 21 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven LS in the anogenital area.
- Baseline IGA score ≥ 2 for LS.
- Baseline Itch NRS score ≥ 4 in anogenital area.
- Willingness to avoid pregnancy.
Who cannot join
- Participants who do not have LS involving anogenital area.
- Concurrent conditions and history of other diseases:
- Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex.
- Have active genital/vulvar lesions at screening and Day 1, not related to LS
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
- Laboratory values outside of the protocol-defined criteria
- Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
- Other exclusion criteria may apply.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Apex Dermatology
Ashtabula, Ohio, 44004
Bexley Dermatology
Bexley, Ohio, 43209
Cahaba Dermatology
Birmingham, Alabama, 35244
Unc Dermatology and Skin Cancer Center At Southern Village
Chapel Hill, North Carolina, 27516
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
UC Irvine
Irvine, California, 92697
New Age Medical Research Corporation
Miami, Florida, 33186
University of Utah Health Care Midvalley Health Center Dermatology
Murray, Utah, 84107
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Seattle Skin and Laser Clinic
Seattle, Washington, 98105
The Centers For Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
Circuit Clinical
West Seneca, New York, 14224
Canada2 sites
Clinique Rsf
Québec, Quebec, G1V 3M7
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
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.
- Conditions
- Lichen Sclerosus
- Being tested
- Ruxolitinib cream, Vehicle cream
- Keywords
- Lichen Sclerosus, Skin Diseases, 18424, Ruxolitinib, topical cream, vulvar disease
- Medical subject headings
- Lichen Sclerosus et Atrophicus, Skin Diseases, Vulvar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib creamDrug
Also called INCB018424 cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle creamDrug
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib cream | Experimental | 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. Receives: Drug: Ruxolitinib cream; Drug: Vehicle cream |
| Vehicle Cream | Placebo comparator | Vehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension. Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Week 12
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from Week 12 to Week 24 plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start18 Nov 2022
- Primary completion1 Sep 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will be a 12 week double-blind period followed by a 12 week open label period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haq Nawaz, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593445
- Sponsor's protocol ID
- INCB 18424-220
- Status last verified
- Aug 2024
- First submitted
- 21 Oct 2022
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT05593445
- Acronym / sponsor ID
- INCB 18424-220
- Conditions
- Lichen Sclerosus
- Keywords
- Lichen Sclerosus, Skin Diseases, 18424, Ruxolitinib, topical cream, vulvar disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study will be a 12 week double-blind period followed by a 12 week open label period.
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib cream | Experimental | Drug: Ruxolitinib cream, Drug: Vehicle creamRuxolitinib 1.5% cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle creamVehicle cream BID for 12 weeks followed by ruxolitinb 1.5% cream BID (or QD) for 12-weeks in an open-label extension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proven LS in the anogenital area.
- Baseline IGA score ≥ 2 for LS.
- Baseline Itch NRS score ≥ 4 in anogenital area.
- Willingness to avoid pregnancy.
Key exclusion criteria (8 listed)
- Participants who do not have LS involving anogenital area.
- Concurrent conditions and history of other diseases:
- Laboratory values outside of the protocol-defined criteria
- Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
- Other exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib creamAlso: INCB018424 creamRuxolitinib cream is a topical formulation applied as a thin film to affected areas. | Drug | Ruxolitinib cream |
| Vehicle creamVehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream. | Drug | Ruxolitinib cream, Vehicle Cream |
Primary outcome
Percentage of Participants With ITCH4 at Week 12
Time frame: Baseline; 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.
11 secondary outcomes
Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12
Time frame: Baseline; Week 12
Change From Baseline in the Skin Pain NRS Score at Week 12
Time frame: Baseline; Week 12
Time to Achieve ITCH4
Time frame: up to 99.0 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
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
Time frame: from Baseline to Week 12 plus 30 days
Number of Participants With Any TEAE During the Open-label Extension Period
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
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
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
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
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
Time frame: from Week 12 to Week 24 plus 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haq Nawaz, MD study director
Incyte Corporation
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib cream in people with Lichen Sclerosus, run by Incyte Corporation at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With ITCH4 at Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.