An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo

Phase 1

• Conditions: onsegmental vitiligo with genital involvement; MedDRA version: 21.1Level: PTClassification code: 10047642Term: Vitiligo Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-503737-22-00
• Lead Sponsor: Incyte Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Ability to comprehend and willingness to sign an ICF for the study., Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted., Male and female participants must be willing to take appropriate contraceptive measures (see Appendix A) to avoid pregnancy or fathering a child for the duration of study participation with the exception of the following: a. Females of non–childbearing potential (ie, or surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, = 12 months of amenorrhea without an alternative medical cause)., Age = 18 years at the time of signing the ICF., Clinical diagnosis of nonsegmental vitiligo with genital involvement; the genital area (approximately 1% BSA) is defined as labia majora, labia minora, and perineum in females, and penis, scrotum, and perineum in males., At least = 0.25% BSA of nonsegmental vitiligo in the genital area., Presence of pigmented hair within the depigmented areas (if the area is hair bearing)., At least 1 genital target lesion that is = 0.1% BSA that has a pigmented hair within it., Vitiligo on areas of the body besides the genitals., Total body vitiligo area not exceeding 10% BSA., Willing to have genital photography conducted.

Exclusion Criteria

Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, balanitis xerotica obliterans, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)., Any of the following clinical laboratory test results at screening: a. Hemoglobin < 100 g/L (ie, 10 g/dL) b. Absolute neutrophil count < 1.5 × 109/L (ie, 1500/µL) c. Platelet count < 1 × 1011/L (ie, 100,000/µL) d. AST or ALT = 2.5 × ULN e. Total bilirubin > 1.5 × ULN unless Gilbert's syndrome f. Estimated glomerular filtration rate < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation) g. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant., Use of any of the following treatments within the indicated washout period before baseline: a. 1 week: Topical drugs when used on the vitiligo areas (eg, corticosteroids, calcineurin, bimatoprost, phosphodiesterase type 4 inhibitors, retinoids). b. 4 weeks: - Melanocyte-stimulating agents (eg, afamelanotide). - Immunomodulating systemic medications (eg, corticosteroids, methotrexate, cyclosporine). - Live vaccines. Note: Live-attenuated vaccines are prohibited during the course of the study and within 4 weeks after the EOT visit. c. 12 weeks: - JAK inhibitors, systemic or topical. - Laser or any kind of phototherapy, including tanning bed or intentional UV exposure. d. 5 half-lives or 12 weeks, whichever is longer: Biologic agents, investigational or experimental therapy or procedures for vitiligo. Investigational biologics should be discussed with the sponsor to determine whether a longer period of discontinuation is required., Body mass index < 17 or > 40 kg/m2., Pregnant or lactating participants, or those considering pregnancy during the period of their study participation., History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the application schedule and study assessments., Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug study., Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities., In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations., Employees of the sponsor or investigator or are otherwise dependents of them., Known allergy or reaction to any component of the study drug formulation., Prior or current use of depigmentation treatments (eg, monobenzone)., Active or recurrent genital warts or herpes., Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia., An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum)., Had = 3 laser hair removal treatments in an area to be treated for vitiligo., No venous access outside of areas to be treated., Concurrent conditions and history of other diseases as follows: a. Any other skin disorder that, in th

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified