Efficacy and tolerability of the combination of anifrolumab (300 mg IV) and phototherapy versus phototherapy in adults with progressive vitiligo

Phase 2

Recruiting

• Conditions: Patient with non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet

• Registration Number: 2024-512041-17-00
• Lead Sponsor: Centre Hospitalier Universitaire De Bordeaux

Brief Summary

To evaluate the efficacy of the combination of anifrolumab intravenous (IV) every four weeks + UVB TL01 (twice a week) by the evaluation of the percentage of skin repigmentation after 36 weeks of treatment using the VASI score in the experimental group receiving anifrolumab + UVB TL01.

Detailed Description

Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing ANIFROLUMAB (300mg/month) + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start ANIFROLUMAB 3 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at week 12, 24, 36 and 48.

Study Timeline

• Study First Posted: 2024-09-18
• Last Update Posted: 2025-06-16

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

Subject male or female aged ≥ 18 years and ≤ 65 years

Subject with body weight > or = 40kg

Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet

Active non-segmental vitiligo is defined by: • Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND • Presence of hypochromic aspect under Wood’s lamp examination and/or perifollicular hypopigmentation under Wood’s lamp examination.

Able to read, understand, and give documented (electronic or paper signature) informed consent

Affiliated or beneficiary of the French Social Security

Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2): phototherapy.

Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization and throughout the study: systemic steroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine.

Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization and throughout the study: • TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus) • Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) • Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments.

Exclusion Criteria

Segmental or mixed vitiligo

Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus) that would interfere with evaluations of the effect of study medication on vitiligo.

Patients who are currently experiencing a skin infection that requires treatment, or who are currently being treated, with topical or systemic antibiotics. Note: Patients may not be rescreened until at least 4 weeks after the date of their previous screen failure and at least 2 weeks after resolution of the infection.

Patients with history of basal cell or squamous epithelial skin cancer or melanoma

Presence of significant uncontrolled neuropsychiatric disorder, are clinically judged by the investigator to be at risk for suicide.

Have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).

Current alcohol, drug, or chemical abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline and week 36.		Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline and week 36.

Secondary Outcome Measures

Name	Time	Method
The safety and tolerability of anifrolumab and phototherapy will be assessed based on clinical and biological exams.		The safety and tolerability of anifrolumab and phototherapy will be assessed based on clinical and biological exams.
Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline, week 12, 24 and 48.		Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline, week 12, 24 and 48.
Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 12, 24, 36 and 48		Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 12, 24, 36 and 48
Mean variation in percentage of Vitiligo European Task Force (VETF) score between baseline , week 12, 24, 36 and 48		Mean variation in percentage of Vitiligo European Task Force (VETF) score between baseline , week 12, 24, 36 and 48
Mean variation in percentage of Vitiligo Extent Score (VES) score between baseline , week 12, 24, 36 and 48		Mean variation in percentage of Vitiligo Extent Score (VES) score between baseline , week 12, 24, 36 and 48
Evolution of the activity of vitiligo will be assessed by measuring the variation in percentage of the Vitiligo Signs of Activity Score (VSAS) between baseline , week 12, 24, 36 and 48		Evolution of the activity of vitiligo will be assessed by measuring the variation in percentage of the Vitiligo Signs of Activity Score (VSAS) between baseline , week 12, 24, 36 and 48
Variation of the Dermatology Life Quality Index (DLQI) between baseline, week 12, 24, 36 and 48		Variation of the Dermatology Life Quality Index (DLQI) between baseline, week 12, 24, 36 and 48
Variation of the Score of the Skindex 29 between inclusion, week 12, 24, 36 and 48		Variation of the Score of the Skindex 29 between inclusion, week 12, 24, 36 and 48
Variation of the Vitiligo Impact Scale (VIPs) between inclusion, week 12, 24, 36 and 48 weeks		Variation of the Vitiligo Impact Scale (VIPs) between inclusion, week 12, 24, 36 and 48 weeks
Evolution of vitiligo noticeability scale (VNS) score between inclusion, week 12, 24, 36 and 48		Evolution of vitiligo noticeability scale (VNS) score between inclusion, week 12, 24, 36 and 48
Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) between inclusion, week 12, 24, 36 and 48		Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) between inclusion, week 12, 24, 36 and 48
Evolution of Patient's Global Impression of Change-Vitiligo (PaGIC-V) between inclusion, week 12, 24, 36 and 48		Evolution of Patient's Global Impression of Change-Vitiligo (PaGIC-V) between inclusion, week 12, 24, 36 and 48
Evolution of Total – Physician Global Vitiligo Assessment (T-PhGVA) between inclusion, week 12, 24, 36 and 48		Evolution of Total – Physician Global Vitiligo Assessment (T-PhGVA) between inclusion, week 12, 24, 36 and 48
Evolution of Total – Patient Global Vitiligo Assessment (T-PaGVA) between inclusion, week 12, 24, 36 and 48		Evolution of Total – Patient Global Vitiligo Assessment (T-PaGVA) between inclusion, week 12, 24, 36 and 48
Blood inflammatory markers will be measured at inclusion, week 12, 24, 36 weeks using multiplex ELISA on patients’ serum Skin inflammatory markers will be measured at inclusion, 12 and 36 weeks using immunofluorescence on skin biopsies, and transcriptomic analysis on skin biopsies.		Blood inflammatory markers will be measured at inclusion, week 12, 24, 36 weeks using multiplex ELISA on patients’ serum Skin inflammatory markers will be measured at inclusion, 12 and 36 weeks using immunofluorescence on skin biopsies, and transcriptomic analysis on skin biopsies.

Trial Locations

Locations (5)

Hospices Civils De Lyon; 🇫🇷 Bron, France

Centre Hospitalier Universitaire De La Reunion; 🇫🇷 St Denis, France

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Universitaire De Nice; 🇫🇷 Nice, France

Centre Hospitalier Le Mans; 🇫🇷 Le Mans Cedex 9, France

Hospices Civils De Lyon

🇫🇷Bron, France

Cécile LESORT

Site contact

+33472117211

cecile.lesort@chu-lyon.fr