non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet MedDRA version: 21.1 Level: PT Classification code 10047642 Term: Vitiligo System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Saphnelo
Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Anifrolumab
CAS Number: 1326232-46-5
Concentration unit: mg/ml mil
Sponsors
Centre Hospitalier Universitaire de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject: male or female aged = 18 years and = 65 years - Subject with body weight ? 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 - Registered in 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) and throughout the study: systemic steroids, phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine. - Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization (Visit 2) 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. - Patient characteristics - Are male or nonpregnant, nonbreastfeeding female patients, except: a. Male patients must agree to use 2 forms of birth control (1 must be highly effective, see below) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 4 weeks following the last dose of investigational product. b. Female patients of childbearing potential must agree to use 2 forms of birth control, when engaging in sexual intercourse with a male partner while enrolled in the study and for at least 12 weeks following the last dose of investigational product. The following birth control methods are considered acceptable (the patient should choose 2 to be used with their male partner, and 1 must be highly effective): • Highly effective birth control methods: oral, injectable, or implanted hormonal contraceptives (combined estrogen/progesterone or progesterone only, associated with inhibition of ovulation); intrauterine device (containing copper) or intrauterine system (e.g., progestin-releasing coil); or vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate). • Effective birth control methods: condom with a spermicidal foam, gel, film, cream, or suppository; occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository; or oral hormonal contraceptives. c. Females of nonchildbearing potential are not required to use birth control and they are defined as: • Women =60 years of age or women who are congenitally sterile, or • Women =40 and <60 years of age who have had a cessation of menses for =12 months and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (=40 mIU/mL or =40 IU/L), or women who are surgically sterile (i.e., have had a hysterectomy or bilateral oophorectomy or tubal ligation). - Patients fully vaccinated against COVID-19. A patient is considered fully vaccinated =2 weeks after receipt of the second dose in a 2-dose series (Pfizer-BioNTech and Moderna) or = 2 weeks after receipt of the single dose of the Janssen vaccine. - Signed informed consent form (ICF) Are the tria
Exclusion criteria
Exclusion criteria: General exclusion criteria - Segmental or mixed vitiligo - Patients that 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. - Patients that 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). - 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. - Current alcohol, drug, or chemical abuse. Other non inclusion criteria - Have hypersensitivity to anifrolumab or to any of the excipients. - Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures. - Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. - Have participated within the last 30 days in a clinical study involving an investigational product. If the previous investigational product has a long half-life (2 weeks or longer), at least 3 months or 5 half-lives (whichever is longer) should be allowed between the end of the previous treatment and the inclusion. - Have previously been randomized in this study or any other study investigating anifrolumab. - Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Evaluate the efficacy of the combination of ANIFROLUMAB IV every four weeks + UVB TL01 (twice a week) by the evaluation of the percentage of skin repigmentation after 12 weeks of treatment using the VASI score in the experimental group receiving ANIFROLUMAB + UVB TL01. Following objectives will be evaluated 12, 20 and 36 weeks after inclusion. •To evaluate the safety and tolerability of the combination of ANIFROLUMAB IV Following objectives will be evaluated 48 weeks after inclusion: 12 weeks after stopping the experimental procedure;Primary end point(s): Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score between baseline and week 36 ;Timepoint(s) of evaluation of this end point: Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The safety and tolerability of ANIFROLUMAB and phototherapy will be assessed based on clinical and biological exams. - Evolution of vitiligo disease - 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 quality of life will be assessed - 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. ;Timepoint(s) of evaluation of this end point: week 12, 24, 36 and 48 | — |
Countries
France
Contacts
Public ContactProject manager
Centre Hospitalier Universitaire de Bordeaux
Outcome results
None listed