Anifrolumab for Non-segmental vitiligo

Inclusion criteria

• {"criterion_text":"- Subject male or female aged ≥ 18 years and ≤ 65 years"}
• {"criterion_text":"- Subject with body weight > or = 40kg"}
• {"criterion_text":"- Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet"}
• {"criterion_text":"- Active non-segmental vitiligo is defined by: •\tNon-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND •\tPresence of hypochromic aspect under Wood’s lamp examination and/or perifollicular hypopigmentation under Wood’s lamp examination."}
• {"criterion_text":"- Able to read, understand, and give documented (electronic or paper signature) informed consent"}
• {"criterion_text":"- Affiliated or beneficiary of the French Social Security"}
• {"criterion_text":"- Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2): phototherapy."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization and throughout the study: •\tTCS or topical immune modulators (e.g., tacrolimus or pimecrolimus) •\tTopical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) •\tTopical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments."}

Exclusion criteria

• {"criterion_text":"- Segmental or mixed vitiligo"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients who are currently experiencing a skin infection that requires treatment, or who are currently being treated, with topical or systemic antibiotics. \tNote: 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."}
• {"criterion_text":"- Patients with history of basal cell or squamous epithelial skin cancer or melanoma"}
• {"criterion_text":"- Presence of significant uncontrolled neuropsychiatric disorder, are clinically judged by the investigator to be at risk for suicide."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Current alcohol, drug, or chemical abuse."}

Primary endpoints

• {"endpoint_text":"- Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline and week 36.","definition_or_measurement_approach":"Mean change in percentage VASI score between baseline and week 36; VASI is used to assess percentage of skin repigmentation after 36 weeks of treatment in the experimental group."}

Secondary endpoints

• {"endpoint_text":"- The safety and tolerability of anifrolumab and phototherapy will be assessed based on clinical and biological exams.","definition_or_measurement_approach":"Safety and tolerability assessed via clinical examinations and biological (laboratory) tests."}
• {"endpoint_text":"- Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline, week 12, 24 and 48.","definition_or_measurement_approach":"Mean change in percentage VASI score measured at baseline and at weeks 12, 24 and 48."}
• {"endpoint_text":"- Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 12, 24, 36 and 48","definition_or_measurement_approach":"Mean change in percentage F-VASI measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Mean variation in percentage of Vitiligo European Task Force (VETF) score between baseline , week 12, 24, 36 and 48","definition_or_measurement_approach":"Mean change in percentage VETF score measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Mean variation in percentage of Vitiligo Extent Score (VES) score between baseline , week 12, 24, 36 and 48","definition_or_measurement_approach":"Mean change in percentage VES measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Mean change in percentage VSAS measured at baseline and at weeks 12, 24, 36 and 48 to assess disease activity."}
• {"endpoint_text":"- Variation of the Dermatology Life Quality Index (DLQI) between baseline, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in DLQI score measured at baseline and at weeks 12, 24, 36 and 48 to assess quality of life."}
• {"endpoint_text":"- Variation of the Score of the Skindex 29 between inclusion, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in Skindex-29 score measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Variation of the Vitiligo Impact Scale (VIPs) between inclusion, week 12, 24, 36 and 48 weeks","definition_or_measurement_approach":"Change in VIPs score measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Evolution of vitiligo noticeability scale (VNS) score between inclusion, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in VNS score measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) between inclusion, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in PhGIC-V measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Evolution of Patient's Global Impression of Change-Vitiligo (PaGIC-V) between inclusion, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in PaGIC-V measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Evolution of Total – Physician Global Vitiligo Assessment (T-PhGVA) between inclusion, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in T-PhGVA measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Evolution of Total – Patient Global Vitiligo Assessment (T-PaGVA) between inclusion, week 12, 24, 36 and 48","definition_or_measurement_approach":"Change in T-PaGVA measured at baseline and at weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Blood inflammatory markers by multiplex ELISA on serum at baseline and weeks 12, 24, 36; skin inflammatory markers by immunofluorescence on skin biopsies at baseline, week 12 and week 36; transcriptomic analysis on skin biopsies as specified."}

France

Earliest CTIS Part Ii Submission Date

09-09-2024

Latest Decision Or Authorization Date

13-01-2026

Processing Time Days

491

Number Of Sites

5

Number Of Participants

48

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France