Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo (VITANI)

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ClinicalTrials.gov Identifier: NCT05917561

Recruitment Status : Recruiting

First Posted : June 26, 2023

Last Update Posted : December 22, 2023

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Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

University Hospital, Bordeaux

Study Description

Brief Summary:

The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of ANIFROLUMAB in combination with phototherapy in adult participants with non-segmental progressive vitiligo

Condition or disease	Intervention/treatment	Phase
Vitiligo	Drug: Anifrolumab Infusion Product Drug: Placebo	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	This is a multicenter, randomized, non-comparative, phase II proof-of-concept trial involved patients with progressive vitiligo and uses one of the most common regimens in this phase of study. Assessment of the experimental treatment efficacy will be estimated only on the results obtained in the experimental treatment arm (Anifrolumab 300mg/month + narrowband UVB TL01 arm).
Masking:	Double (Participant, Investigator)
Masking Description:	Double (Participant, Investigator) This is a double-blind study. To preserve the blinding of the study, a minimum number of sponsor personnel will see the randomization table and treatment assignments before the study is complete. All study assessments will be performed by study personnel who are blinded to the patient's treatment group. Except in clinical circumstances where unblinding is required, the patients, investigators, sponsor study team, and any personnel interacting directly with patients or investigative sites will remain blinded to Anifrolumab and placebo assignment until after completion of the Double-Blinded Treatment Period.
Primary Purpose:	Treatment
Official Title:	Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double Blind Prospective, Non Comparative Proof of Concept Phase II Study
Actual Study Start Date :	December 15, 2023
Estimated Primary Completion Date :	May 1, 2026
Estimated Study Completion Date :	May 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo

MedlinePlus related topics: Vitiligo

Drug Information available for: Anifrolumab

Genetic and Rare Diseases Information Center resources: Hypomelanotic Disorder

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phototherapy associated with active treatment Anifrolumab 300mg/infusion/month for 36 weeks + UVB TL01: 2 times a week during 24 weeks. (Phototherapy will be started 12 weeks after the beginning of anifrolumab)	Drug: Anifrolumab Infusion Product Anifrolumab 300mg/month infusion for 36 weeks
Placebo Comparator: Phototherapy associated with placebo Placebo once a month infusion for 36 weeks + UVB TL01: 2 times a week during 24 weeks.	Drug: Placebo Placebo once a month, infusion for 36 weeks

Outcome Measures

Primary Outcome Measures :

Score with VASI score [ Time Frame: Week 36 ]
The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.

Secondary Outcome Measures :

Score with VASI score [ Time Frame: Week 12 ]
Change in percentage of repigmented Surface area 12 weeks after-inclusion, by using the VASI score at week 12.

The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study
Score with VASI score Extent Score (VES) [ Time Frame: Week 24 ]
Change in percentage of repigmented Surface area 24 weeks after-inclusion, by using the VASI score at week 24.

The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Score with VASI score Extent Score (VES) [ Time Frame: Week 48 ]
Change in percentage of repigmented Surface area 24 weeks after-inclusion, by using the VASI score at week 24.

The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Face Vitiligo Aera Scoring Index (F-VASI) score [ Time Frame: Week 12 ]
Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 12
Face Vitiligo Aera Scoring Index (F-VASI) score [ Time Frame: Week 24 ]
Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 24
Face Vitiligo Aera Scoring Index (F-VASI) score [ Time Frame: Week 36 ]
Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 36
Face Vitiligo Aera Scoring Index (F-VASI) score [ Time Frame: Week 48 ]
Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 48
Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs [ Time Frame: Week 36 ]
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy, or require changes in the study drug.
Evaluation of score Vitiligo European Task Force (VETF) [ Time Frame: Week 12 ]
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening <30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Evaluation of score Vitiligo European Task Force (VETF) [ Time Frame: Week 24 ]
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening <30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Evaluation of score Vitiligo European Task Force (VETF) [ Time Frame: Week 36 ]
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening <30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Evaluation of score of the Vitiligo Extent Score (VES) [ Time Frame: Week 48 ]
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS) [ Time Frame: Week 12 ]
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS) [ Time Frame: Week 24 ]
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS) [ Time Frame: Week 36 ]
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS) [ Time Frame: Week 48 ]
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V) [ Time Frame: Week 12 ]
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V) [ Time Frame: Week 24 ]
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V) [ Time Frame: Week 36 ]
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V) [ Time Frame: Week 48 ]
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Evaluation of the score of the Skindex 29 [ Time Frame: Week 12 ]
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Evaluation of the score of the Skindex 29 [ Time Frame: Week 24 ]
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Evaluation of the score of the Skindex 29 [ Time Frame: Week 36 ]
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Evaluation of the score of the Vitiligo Impact Patient Scale (VIP) [ Time Frame: Week 48 ]
Variation of the score of the Vitiligo Impact Patient Scale (VIP). Vitiligo Impact Scale is a 12-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Evaluation of the score of the Vitiligo Impact Patient Scale (VIP) [ Time Frame: Week 12 ]
Variation of the score of the Vitiligo Impact Patient Scale (VIP). Vitiligo Impact Scale is a 12-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Evaluation of the score of the Vitiligo Impact Patient Scale (VIP) [ Time Frame: Week 24 ]
Variation of the score of the Vitiligo Impact Patient Scale (VIP). Vitiligo Impact Scale is a 12-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Evaluation of the score of the Vitiligo Impact Patient Scale (VIP) [ Time Frame: Week 36 ]
Variation of the score of the Vitiligo Impact Patient Scale (VIP). Vitiligo Impact Scale is a 12-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Evaluation of the Vitiligo Noticeability Scale (VNS) [ Time Frame: Week 12 ]
Variation of the VNS score. The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. higher score corresponds to worse symptom impact
Evaluation of the Vitiligo Noticeability Scale (VNS) [ Time Frame: Week 24 ]
Variation of the VNS score. The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. higher score corresponds to worse symptom impact
Evaluation of the Vitiligo Noticeability Scale (VNS) [ Time Frame: Week 36 ]
Variation of the VNS score. The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. higher score corresponds to worse symptom impact
Evaluation of the Vitiligo Noticeability Scale (VNS) [ Time Frame: Week 48 ]
Variation of the VNS score. The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. higher score corresponds to worse symptom impact
Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) [ Time Frame: Week 12 ]
Variation of the PhGIC-V. The PhGIC-V is a physician measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) [ Time Frame: Week 24 ]
Variation of the PhGIC-V. The PhGIC-V is a physician measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) [ Time Frame: Week 36 ]
Variation of the PhGIC-V. The PhGIC-V is a physician measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V) [ Time Frame: Week 48 ]
Variation of the PhGIC-V. The PhGIC-V is a physician measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V) [ Time Frame: Week 12 ]
Variation of the PaGIC-V. The PaGIC-V is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V) [ Time Frame: Week 24 ]
Variation of the PaGIC-V. The PaGIC-V is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V) [ Time Frame: Week 36 ]
Variation of the PaGIC-V. The PaGIC-V is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V) [ Time Frame: Week 48 ]
Variation of the PaGIC-V. The PaGIC-V is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. Overall improvement: (1) much improved, (2)minimally improved, (3)no change), (4)minimally worse, (5)much worse. Higher score corresponds to worse symptom.
Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA) [ Time Frame: Week 12 ]
Variation fo the T-PhGVA: The T-PhGVA is a physician measure of vitiligo treatment success that is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive). Higher score corresponds to worse evaluation
Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA) [ Time Frame: Week 24 ]
Variation fo the T-PhGVA: The T-PhGVA is a physician measure of vitiligo treatment success that is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive). Higher score corresponds to worse evaluation
Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA) [ Time Frame: Week 36 ]
Variation fo the T-PhGVA: The T-PhGVA is a physician measure of vitiligo treatment success that is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive). Higher score corresponds to worse evaluation
Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA) [ Time Frame: Week 48 ]
Variation fo the T-PhGVA: The T-PhGVA is a physician measure of vitiligo treatment success that is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive). Higher score corresponds to worse evaluation
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex. [ Time Frame: Day 1 ]
Expression of IFN-α, TNF-α, IFN-γ, IL-4, IL-5, IL-12, IL-13, IL-15, IL-17, IL-22, IL-23, IL-33 CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, soluble HSP70.
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex. [ Time Frame: Week 12 ]
Expression of IFN-α, TNF-α, IFN-γ, IL-4, IL-5, IL-12, IL-13, IL-15, IL-17, IL-22, IL-23, IL-33 CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, soluble HSP70.
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex. [ Time Frame: Week 36 ]
Expression of IFN-α, TNF-α, IFN-γ, IL-4, IL-5, IL-12, IL-13, IL-15, IL-17, IL-22, IL-23, IL-33 CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, soluble HSP70.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 (e.g. 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:
1. 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.
2. 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.
3. Females of non-childbearing 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 folliculostimulating hormone (FSH) test confirming non-childbearing 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).
Signed informed consent form (ICF)

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

Exclusion criteria related to concomitant medications

Patients that have been treated with the following therapies:
1. monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for less than 5 half-lives prior to randomization.
2. received prior treatment with any oral JAK inhibitor (e.g., tofacitinib, ruxolitinib)
3. received any systemic corticosteroid administered within 4 weeks prior to planned randomization or are anticipated to require systemic corticosteroids during the study.
4. received any systemic treatment with Methotrexate, Azathioprine, Cyclosporine within 12 weeks prior to planned randomization
5. have had an intra-articular corticosteroid injection within 4 weeks prior to planned randomization.
6. have received more than 250 UV lights sessions
Patients that are largely or wholly incapacitated permitting little or no self-care, such as being bedridden.

Exclusion criteria related to infection and malignancy risk factors

Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
An HIV test must be performed. The result should be available within 30 days of randomisation, but prior to the second dose of investigational product administration (Visit 2/Week 4).

Confirmed positive test for hepatitis B serology for:

Hepatitis B surface antigen, OR
Hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantitation Note: Patients who were HBcAb positive at screening were tested every 3 months for HBV DNA. To remain eligible for the study, the patient's HBV DNA levels must have remained below the limit of quantitation
- Positive test for hepatitis C antibody
- Any of the following:
  1. Clinically significant chronic infection (ie, osteomyelitis, bronchiectasis, etc) within 8 weeks prior to Inclusion Visit (chronic nail infections not causing open skin lesions are allowed)
  2. Any infection requiring hospitalisation or treatment with IV anti-infectives not completed at least 4 weeks prior to Inclusion visit
- Any infection requiring IV or oral anti-infectives (including antivirals) within 2 weeks prior to Inclusion visit
- Have evidence of active TB or latent TB:
  1. have evidence of active TB, defined in this study as the following: Documented by a positive PPD test (≥5 mm induration between approximately 48 and 72 hours after application, regardless of vaccination history), medical history, clinical features, and abnormal chest x-ray at screening. The QuantiFERON®-TB Gold test or TSPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. Patients are excluded from the study if the test is not negative and there is clinical evidence of active TB.
    
    Exception: Patients with a history of active TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria are met. Such patients would not be required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT® TB test but must have a chest x-ray at screening.
  2. have evidence of untreated/inadequately or inappropriately treated latent TB, defined in this study as the following: documented to have a positive PPD test (≥5 mm induration between approximately 48 and 72 hours after application, regardless of vaccination history), no clinical features consistent with active TB, and a chest x-ray with no evidence of active TB at screening; or PPD test is positive and the patient has no medical history or chest x-ray findings consistent with active TB, the patient may have a QuantiFERON®-TB Gold test or TSPOT® TB test (as available and if compliant with local TB guidelines). If the test results are not negative, the patient will be considered to have latent TB (for purposes of this study); or QuantiFERON®-TB Gold test or T-SPOT® TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. If the test results are positive, the patient will be considered to have latent TB. If the test is not negative, the test may be repeated once within approximately 2 weeks of the initial value. If the repeat test results are again not negative, the patient will be considered to have latent TB (for purposes of this study). Exception: Patients who have evidence of latent TB may be enrolled if he or she completes at least 4 weeks of appropriate treatment prior to randomization and agrees to complete the remainder of treatment while in the trial.

Exception: Patients with a history of latent TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria are met.

Such patients would not be required to undergo the protocol specific TB testing for PPD, QuantiFERON®-TB Gold test, or TSPOT® TB test but must have a chest x-ray at screening.

Safety exclusions labs
At Screening (within 4 weeks before Week 0 [Day 1]), any of the following:
1. Aspartate aminotransferase (AST) >2.0 × upper limit of normal (ULN).
2. Alanine aminotransferase (ALT) >2.0 × ULN.
3. Total bilirubin >1.5ULN (unless due to Gilbert's syndrome)
4. Serum creatinine >2.0 mg/dL (or >181 μmol/L)
5. Neutrophil count <1000/μL (or <1.0 × 109/L)
6. Platelet count <25000/μL (or <25 × 109/L)
7. Haemoglobin <8 g/dL (or <80 g/L),
8. Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic subjects only) Note: Abnormal screening laboratory tests may be repeated ONCE on a separate sample before subject is declared a screen failure.
Confirmed COVID-19: The Baseline Visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic subjects must have recovered, defined as resolution of fever without use of antipyretics and improvement in symptoms;
Suspected COVID-19: Subjects with signs/symptoms suggestive of COVID-19, known exposure, or high risk behavior should undergo molecular (e.g., polymerase chain reaction [PCR]) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure. Perioperative management of investigational product Surgery should be avoided during the study if clinically feasible, but is permitted. If a surgery becomes necessary during the study, it should be scheduled at least 4 weeks after the previous administration of investigational product.

For non-major surgery, the decision to withhold investigational product administration is at the Investigator's discretion.

For major surgery, investigational product administration can be resumed at the Investigator's discretion after all of the following criteria are met:

External wound healing is complete, and
Any postoperative antibiotic course is completed, and
All acute surgical complications have resolved Blood donations Subjects should not donate whole blood, blood components or sperm until the completion of the follow-up period.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05917561

Contacts

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Contact: Julien SENESCHAL, Prof	+33 (0)5 56 79 49 63	julien.seneschal@chu-bordeaux.fr
Contact: Frédéric PERRY	+33 (0)5 57 82 11 58	frederic.perry@chu-bordeaux.fr

Locations

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France
CHU de Bordeaux	Recruiting
Bordeaux, France, 33075
Contact: JULIEN SENESCHAL, PROF +33 (0)5 56 79 49 63 julien.seneschal@chu-bordeaux.fr
Centre Hospitalier Régional Le Mans	Not yet recruiting
Le Mans, France, 72037
Contact: Hervé MAILLARD, Dr +33 (0)2 49 81 25 07 hmaillard@ch-lemans.fr
Centre Hospitalier Universitaire de Nice	Not yet recruiting
Nice, France, 06000
Contact: Thierry PASSERON, Prof 04 92 03 55 25 thierry.passeron@unice.fr
Centre Hospitalier Universitaire de Toulouse	Not yet recruiting
Toulouse, France, 31059
Contact: Juliette MAZEREEUW-HAUTIER, PROF 05.67.77.81.41 mazereeuw.sec@chu-toulouse.fr

Sponsors and Collaborators

University Hospital, Bordeaux

AstraZeneca

More Information

Publications:

Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.

Picardo M, Dell'Anna ML, Ezzedine K, Hamzavi I, Harris JE, Parsad D, Taieb A. Vitiligo. Nat Rev Dis Primers. 2015 Jun 4;1:15011. doi: 10.1038/nrdp.2015.11.

Whitton ME, Pinart M, Batchelor J, Leonardi-Bee J, Gonzalez U, Jiyad Z, Eleftheriadou V, Ezzedine K. Interventions for vitiligo. Cochrane Database Syst Rev. 2015 Feb 24;2015(2):CD003263. doi: 10.1002/14651858.CD003263.pub5.

Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.

Boniface K, Seneschal J, Picardo M, Taieb A. Vitiligo: Focus on Clinical Aspects, Immunopathogenesis, and Therapy. Clin Rev Allergy Immunol. 2018 Feb;54(1):52-67. doi: 10.1007/s12016-017-8622-7.

Bertolotti A, Boniface K, Vergier B, Mossalayi D, Taieb A, Ezzedine K, Seneschal J. Type I interferon signature in the initiation of the immune response in vitiligo. Pigment Cell Melanoma Res. 2014 May;27(3):398-407. doi: 10.1111/pcmr.12219. Epub 2014 Feb 21.

Jacquemin C, Rambert J, Guillet S, Thiolat D, Boukhedouni N, Doutre MS, Darrigade AS, Ezzedine K, Blanco P, Taieb A, Boniface K, Seneschal J. Heat shock protein 70 potentiates interferon alpha production by plasmacytoid dendritic cells: relevance for cutaneous lupus and vitiligo pathogenesis. Br J Dermatol. 2017 Nov;177(5):1367-1375. doi: 10.1111/bjd.15550. Epub 2017 Oct 25.

Boukhedouni N, Martins C, Darrigade AS, Drullion C, Rambert J, Barrault C, Garnier J, Jacquemin C, Thiolat D, Lucchese F, Morel F, Ezzedine K, Taieb A, Bernard FX, Seneschal J, Boniface K. Type-1 cytokines regulate MMP-9 production and E-cadherin disruption to promote melanocyte loss in vitiligo. JCI Insight. 2020 Jun 4;5(11):e133772. doi: 10.1172/jci.insight.133772.

Boniface K, Jacquemin C, Darrigade AS, Dessarthe B, Martins C, Boukhedouni N, Vernisse C, Grasseau A, Thiolat D, Rambert J, Lucchese F, Bertolotti A, Ezzedine K, Taieb A, Seneschal J. Vitiligo Skin Is Imprinted with Resident Memory CD8 T Cells Expressing CXCR3. J Invest Dermatol. 2018 Feb;138(2):355-364. doi: 10.1016/j.jid.2017.08.038. Epub 2017 Sep 18.

Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.

Brown SR, Gregory WM, Twelves CJ, Buyse M, Collinson F, Parmar M, Seymour MT, Brown JM. Designing phase II trials in cancer: a systematic review and guidance. Br J Cancer. 2011 Jul 12;105(2):194-9. doi: 10.1038/bjc.2011.235. Epub 2011 Jun 28.

Ratain MJ, Humphrey RW, Gordon GB, Fyfe G, Adamson PC, Fleming TR, Stadler WM, Berry DA, Peck CC. Recommended changes to oncology clinical trial design: revolution or evolution? Eur J Cancer. 2008 Jan;44(1):8-11. doi: 10.1016/j.ejca.2007.09.011. Epub 2007 Nov 5. No abstract available.

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Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT05917561
Other Study ID Numbers:	CHUBX 2022/03
First Posted:	June 26, 2023 Key Record Dates
Last Update Posted:	December 22, 2023
Last Verified:	December 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Bordeaux:


anifrolumab vitiligo phototherapy randomized

Additional relevant MeSH terms:

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Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases

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