A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

NCT05593445 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 18424-220
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Lichen Sclerosus

Keywords

Lichen Sclerosus; Skin Diseases; 18424; Ruxolitinib; topical cream; vulvar disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline; Week 12

Secondary Outcomes (11)

• Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12

  Baseline; Week 12

• Change From Baseline in the Skin Pain NRS Score at Week 12

  Baseline; Week 12

• Time to Achieve ITCH4

  up to 99.0 days

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period

  from Baseline to Week 12 plus 30 days

• Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period

  from Baseline to Week 12 plus 30 days

Study Arms (2)

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.

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.

Drug: Vehicle cream

Interventions

Ruxolitinib cream DRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Also known as: INCB018424 cream

Ruxolitinib cream

Vehicle cream DRUG

Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Ruxolitinib cream; Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females aged 18 years or older at screening with a biopsy confirmed diagnosis of Lichen Sclerosus
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (14)

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

UC Irvine

Irvine, California, 92697, United States

Location

The Centers For Vulvovaginal Disorders

Washington D.C., District of Columbia, 20037, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

Circuit Clinical

West Seneca, New York, 14224, United States

Location

Unc Dermatology and Skin Cancer Center At Southern Village

Chapel Hill, North Carolina, 27516, United States

Location

Apex Dermatology

Ashtabula, Ohio, 44004, United States

Location

Bexley Dermatology

Bexley, Ohio, 43209, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah Health Care Midvalley Health Center Dermatology

Murray, Utah, 84107, United States

Location

Seattle Skin and Laser Clinic

Seattle, Washington, 98105, United States

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Clinique Rsf

Québec, Quebec, G1V 3M7, Canada

Location

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus; Skin Diseases; Vulvar Diseases

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Haq Nawaz, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Study will be a 12 week double-blind period followed by a 12 week open label period.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: November 18, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 21, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

CA (2); US (12)