RITLECITINIB for Vitiligo

Inclusion criteria

• {"criterion_text":"- 1.\tMen and women with non-segmental vitiligo.\n- 2.\tAge ≥ 18 age old\n- 3.\tBSA involvement between 4% and 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet\n- 4.\tBSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids)\n- 5.\tF-VASI ≥0.5 and T-VASI ≥3\n- 6.\tActive and stable vitiligo\n- 7.\tFor Women of childbearing potential (WOCBP), an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study; Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at baseline;\n- 8.\tAffiliation to a social security system;\n- 9.\tSigned informed consent."}

Exclusion criteria

• {"criterion_text":"- 1.\tPregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration,\n- 10.\tPatients with active infection or other systemic/ inflammatory disease\n- 11.\tTuberculosis or latent tuberculosis\n- 12.\tVulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition\n- 13.\tParticipants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.\n- 2.\tSegmental or mixed vitiligo\n- 3.\tContraindication to nbUVB phototherapy\n- 4.\tConcomitant use of topical or systemic immunosuppressive medication or steroids\n- 5.\tPatients treated before with oral JAK inhibitor, topical treatments (including JAK inhibitors) that could affect vitiligo (eg, corticosteroids, vitamin D3 and calcineurin inhibitor) within 2 Weeks of Day 1 (Baseline) and during the study\n- 6.\tPatients suffering from photodermatosis or taking photosensitive drugs\n- 7.\tPatients with more than 33% of leucotrichia on the lesions (Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions),\n- 8.\tPersonal history of skin cancer\n- 9.\tPersonal history of any malignancies or a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ will be excluded from the study"}

Primary endpoints

• {"endpoint_text":"- The Facial Vitiligo Area Scoring Index (F-VASI) is a tool allowing to assess the depigmentation of the face. Using the fingertips unit (FTU), it calculates the extent of vitiligo on the face by using the number of FTU [20]. %CFB in F-VASI at Week 52 is defined as %CFB FVASIW0-W52 = (FVASIw0 - FVASIw52)/FVASIw0.","definition_or_measurement_approach":"F-VASI assessed using fingertips unit (FTU) to calculate extent of facial vitiligo. Primary measure is % change from baseline (%CFB) in F-VASI at Week 52, defined as (FVASIw0 - FVASIw52)/FVASIw0."}

Secondary endpoints

• {"endpoint_text":"- 1.\tThe Facial Vitiligo Area Scoring Index (F-VASI) is a tool allowing to assess the depigmentation of the face. Using the fingertips unit (FTU), it calculates the extent of vitiligo on the face by using the number of FTU. A decrease in 50% or more of the initial F-VASI is called F-VASI50 and will define a success.\n- 2.\tThe Facial Vitiligo Area Scoring Index (F-VASI) is a tool allowing to assess the depigmentation of the face. Using the fingertips unit (FTU), it calculates the extent of vitiligo on the face by using the number of FTU. A decrease in 75% or more of the initial F-VASI is called F-VASI 75 and will define a success.\n- 3.\tA decrease in 90% or more of the initial F-VASI is called F-VASI 90 and will define a success. The number of patients achieving the F-VASI 90 will be assessed at week 24, week 36, week 52 and week 72.\n- 4.\tT-VASI 50, as define above, will be assessed at week 24, week 36, week 52 and week 72\n- 5.\tT-VASI 75, as define above, will be assessed at week 52 and week 72\n- 6.\t%CFB in FVASI and %CFB in T-VASI at week 12, week 24, week 36 and week 72 will be define\n- 7.\tThe Vitiligo Noticeability scale (VNS) will be used as a patient reported outcome. To assess this scale, the patient is asked to compare using a mirror his present state as compared to picture at baseline\n- 8.\tThe quality of life will be assessed by using VIPs (Vitiligo Impact Patient scale) short form at baseline and week 36, week 52 and week 72.\n- 9.\tAll the adverse events (clinical and biological) occurring over the study period will be collected with their type, grade and severity. At each visit, the investigator will record all the events since the last visit\n- 10.\tThe patient global impression after treatment will be measured PGIC (F/V) and PGIS (F/V) for each visit\n- 11.\tThe activity of the disease will be assessed between baseline and week 12, week 24, week 36, week 52 and week 72, using the VSAS score [26] determined by using at least 3 different anatomical lesional locations.\n- 12.\tResponse based on stabilization of disease, defined as: <15-point increase in T-VASI score between baseline and week 12, week 24, week 36, week 52 and week 72 visit.","definition_or_measurement_approach":"1-3: F-VASI response thresholds defined as F-VASI50 (≥50% decrease), F-VASI75 (≥75% decrease), F-VASI90 (≥90% decrease) assessed at specified weeks. 4-5: T-VASI responses defined analogously and assessed at specified weeks. 6: %CFB in F-VASI and T-VASI at specified timepoints. 7: VNS is a patient-reported comparison to baseline photograph using a mirror. 8: Quality of life measured by VIPs short form at baseline and weeks 36, 52, 72. 9: Safety: collection of all clinical and biological adverse events with type, grade, severity at each visit. 10: Patient Global Impression scales (PGIC/PGIS) assessed each visit. 11: Disease activity assessed using VSAS score across at least 3 lesion locations at specified visits. 12: Disease stabilization defined as <15-point increase in T-VASI between baseline and specified visits."}

France

Earliest CTIS Part Ii Submission Date

17-07-2025

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

20

Number Of Sites

5

Number Of Participants

80

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France