Combination approach with ritlecitinib and nbUVB compared to ritlecitinib alone for treating vitiligo

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

16 Oct 2025 → ongoing

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare between the groups, the mean percentage change of F-VASI and T-VASI between the baseline and week 52.

Secondary objectives 12

1. 1. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving F-VASI-50 at week 24, week 36, week 52 and week 72.
2. 2. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving F-VASI 75 at week 24, week 36, week 52 and week 72.
3. 3. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving F-VASI 90 at week 24, week 36, week 52 and week 72.
4. 4. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving T-VASI50 at week 24, week 36, week 52 and week 72
5. 5. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy achieving T-VASI75 at week 52 and week 72
6. 6. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy, the mean %CFB F-VASI and T-VASI at week 12, week 24, week 36 and week 72
7. 7. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy, the mean change of Vitiligo Noticeability scale (VNS) at week 36, week 52 and week 72
8. 8. To compare the proportion of patients treated with combined ritlecitinib + nbUVB versus ritlecitinib monotherapy, the evolution of quality of life measured using the VIPs short form between baseline and week 36, week 52 and week 72
9. 9. To assess the safety and tolerability of the bi-therapy
10. 10. To compare within each group, the evolution of patient global impression between baseline and each visit
11. 11. To compare within each group, the disease activity between baseline and week 12, week 24, week 36, week 52 and week 72 visit
12. 12. To compare within each group, the disease stabilisation between baseline and week 12, week 24, week 36, week 52 and week 72 visit

Conditions and MedDRA coding

Vitiligo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Men and women with non-segmental vitiligo.
2. 2. Age ≥ 18 age old
3. 3. BSA involvement between 4% and 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet
4. 4. BSA ≥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)
5. 5. F-VASI ≥0.5 and T-VASI ≥3
6. 6. Active and stable vitiligo
7. 7. For 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;
8. 8. Affiliation to a social security system;
9. 9. Signed informed consent.

Exclusion criteria 13

1. 1. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration,
2. 2. Segmental or mixed vitiligo
3. 3. Contraindication to nbUVB phototherapy
4. 4. Concomitant use of topical or systemic immunosuppressive medication or steroids
5. 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
6. 6. Patients suffering from photodermatosis or taking photosensitive drugs
7. 7. Patients 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),
8. 8. Personal history of skin cancer
9. 9. Personal 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
10. 10. Patients with active infection or other systemic/ inflammatory disease
11. 11. Tuberculosis or latent tuberculosis
12. 12. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship, deprived of freedom or with psychiatric condition
13. 13. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 12

1. 1. 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. A decrease in 50% or more of the initial F-VASI is called F-VASI50 and will define a success.
2. 2. 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. A decrease in 75% or more of the initial F-VASI is called F-VASI 75 and will define a success.
3. 3. A 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.
4. 4. T-VASI 50, as define above, will be assessed at week 24, week 36, week 52 and week 72
5. 5. T-VASI 75, as define above, will be assessed at week 52 and week 72
6. 6. %CFB in FVASI and %CFB in T-VASI at week 12, week 24, week 36 and week 72 will be define
7. 7. The 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
8. 8. The 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.
9. 9. All 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
10. 10. The patient global impression after treatment will be measured PGIC (F/V) and PGIS (F/V) for each visit
11. 11. The 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.
12. 12. Response 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Thierry Passeron

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Cynthia CAILLON

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications