Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo

NCT07152626 | Not Yet Recruiting Phase 2

• 2 other identifiers: 25-PP-032025-521504-22-00
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. areas of high stress. Ritlecitinib, an orally administered inhibitor of JAK3 (Janus kinase)/ TEC (tyrosine kinase expressed in hepatocellular carcinoma) has shown effectiveness and safety for the treatment of vitiligo. In a phase 2b trial, three doses of ritlecitinib, 200/50 mg, 100/50 mg, and 50 mg, were all statistically significant versus placebo on the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 in patients with active NSV. Considering that the immune process primarily contributes to depigmentation while ultraviolet (UV) radiation stimulates the differentiation and proliferation of melanocyte stem cells for re-pigmentation, the investigators propose that a combination therapy using ritlecitinib and narrowband UVB (nbUVB) could offer an optimal approach for treating vitiligo patients. The primary objective is thTo compare between the groups, the mean percentage change from baseline in F-VASI and T-VASI at week 52. Following central randomization, patients will be assigned to receive either ritlecitinib 100mg daily (QD) or a combined therapy using ritlecitinib 100mg QD + twice weekly narrowband UVB treatment for a duration of 52 weeks. At the end of this period, all participants will continue for the open-label phase, receiving ritlecitinib 100mg QD. Eligible participants will be stratified by Fitzpatrick Skin Type (FST, also known as phototype). More specifically, there will be 2 strata based on FST targets: (1) FST I to III (2) FST I IV, to VI. Each FST stratum will target to enroll at least 50% participants into the study population. Stratified randomization across FST sub-groups will support the evaluation of a consistent benefit-risk profile across all FST strata. Enrollment of participants with active or stable nonsegmental vitiligo will be proactively managed without formally capping or stratifying. Throughout the study, there will be a total of 8 visits conducted: selection, inclusion, week 4, week 12, week 24, week 36, week 52 and week 72. In patients who volunteer, a skin biopsy will be performed on both the lesional and perilesional areas at baseline, week 4 and week 52. We aim to include between 12 and 20 volunteer patients. Serum and plasma samples will be collected at the screening visit, week 4, week 12, week 24, week 36, week 52 and week 72. A pregnancy test will be performed every 4 weeks i.e. at weeks 8, 16, 20, 28, 32, 40, 44, 48, 56, 60, 64 and 68;

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

• The Facial Vitiligo Area Scoring Index (F-VASI)

  To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving The Facial Vitiligo Area Scoring Index (F-VASI) -75 at week.

  at week 52

• Total Body Vitiligo Scoring Index (T-VASI) 50

  To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving T-VASI50 at week 52

  at week 52

Secondary Outcomes (2)

• Safety treatment

  during 52 weeks

• The quality of life

  during 52 weeks

Study Arms (2)

Drug alone

ACTIVE COMPARATOR

Patients will be assigned to receive either ritlecitinib 100mg daily (QD)

Drug: LITFULO

Drug and UVB

EXPERIMENTAL

patients will be assigned to receive a combined therapy using ritlecitinib 100mg QD + twice weekly narrowband UVB treatment for a duration of 52 weeks.

Procedure: LITFULO and UVB

Interventions

LITFULO DRUG

Following central randomization, patients will be assigned to receive either ritlecitinib 100mg daily (QD) or a combined therapy using ritlecitinib 100mg QD + twice weekly narrowband UVB treatment for a duration of 52 weeks. At the end of this period, all participants will continue for the open-label phase, receiving ritlecitinib 100mg QD. Eligible participants will be stratified by Fitzpatrick Skin Type (FST, also known as phototype).

Drug alone

LITFULO and UVB PROCEDURE

Following central randomization, patients will be assigned to receive either ritlecitinib 100mg daily (QD) or a combined therapy using ritlecitinib 100mg QD + twice weekly narrowband UVB treatment for a duration of 52 weeks. At the end of this period, all participants will continue for the open-label phase, receiving ritlecitinib 100mg QD. Eligible participants will be stratified by Fitzpatrick Skin Type (FST, also known as phototype).

Drug and UVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria:
• o Have undergone hysterectomy or bilateral oophorectomy;
• Have medically confirmed ovarian failure; or
• Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause); 8. Affiliation to a social security system; 9. Signed informed consent.

You may not qualify if:

• \. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration, and 2. Segmental or mixed vitiligo, and 3. Contraindication to nbUVB phototherapy, and 4. Concomitant use of topical or systemic immunosuppressive medication or steroids, and 5. Patients 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
• At any time prior to or during the study:
• Use of permanent depigmentation treatment for vitiligo and/or other types of pigmentation disorder (eg, monobenzone or phenol).
• Previous use of any systemic JAK inhibitor for any disease indication
• Any non-B cell selective lymphocyte depleting agent (eg, alefacept, alemtuzumab) and alkylating agents \[eg, cyclophosphamide or chlorambucil\], total lymphoid irradiation, etc.
• History of MKTP or other surgical treatment for vitiligo.
• Within 6 months of the first dose of study drug or 5 half-lives (if known), or until lymphocyte count returns to normal, whichever is longer and during the study:
• \- Any B-cell-depleting agents including but not limited to rituximab or previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange.
• Within 12 weeks of first dose of study drug or 5 half-lives (if known), whichever is longer and during the study:
• Other immunomodulatory biologic agents or other marketed immunosuppressants.
• IL12/23 inhibitor (eg, ustekinumab)
• Integrin inhibitors (eg, vedolizumab)
• Within 8 weeks of Day 1 and during the study:
• \- Narrow-band UVB phototherapy, Psoralen Ultra-Violet A therapy, or other phototherapy.
• TNF inhibitors (or biosimilars thereof) as described below:

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHu de Nice, Hôpital Archet

Nice, Alpes-Maritime, 06200, France

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Thierry Passeron, PhD

CONTACT

+33492036488; passeron.t@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

FR (1)