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VitiligoPhase 2VITANINCT05917561

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

A Phase 2 study testing Anifrolumab Infusion Product in people with Vitiligo, run by University Hospital, Bordeaux at 4 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Vitiligo
What is being tested?
Anifrolumab Infusion Product
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
4 sitesFrance
Study dates
15 Dec 2023to 1 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • 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.
  • 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.
  • 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)

Who cannot join

  • 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
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  • Presence of significant uncontrolled neuropsychiatric disorder, are clinically judged by the investigator to be at risk for suicide.
  • Current alcohol, drug, or chemical abuse
  • Patients that have been treated with the following therapies:
  • monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for less than 5 half-lives prior to randomization.
  • received prior treatment with any oral JAK inhibitor (e.g., tofacitinib, ruxolitinib)
  • received any systemic corticosteroid administered within 4 weeks prior to planned randomization or are anticipated to require systemic corticosteroids during the study.
  • received any systemic treatment with Methotrexate, Azathioprine, Cyclosporine within 12 weeks prior to planned randomization
  • have had an intra-articular corticosteroid injection within 4 weeks prior to planned randomization.
  • 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:
  • 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)
  • 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:
  • 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.
  • 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:
  • Aspartate aminotransferase (AST) >2.0 × upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) >2.0 × ULN.
  • Total bilirubin >1.5ULN (unless due to Gilbert's syndrome)
  • Serum creatinine >2.0 mg/dL (or >181 μmol/L)
  • Neutrophil count <1000/μL (or <1.0 × 109/L)
  • Platelet count <25000/μL (or <25 × 109/L)
  • Haemoglobin <8 g/dL (or <80 g/L),
  • 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.

Trial locations and contacts

4 sites in 1 country.

Julien SENESCHAL, Prof contact

+33 (0)5 56 79 49 63

julien.seneschal@chu-bordeaux.fr

Frédéric PERRY contact

+33 (0)5 57 82 11 58

frederic.perry@chu-bordeaux.fr

France4 sites, 4 recruiting

  • CHU de Bordeaux

    Bordeaux, 33075

    JULIEN SENESCHAL, PROF, +33 (0)5 56 79 49 63, julien.seneschal@chu-bordeaux.fr

    Recruiting

  • Centre Hospitalier Régional Le Mans

    Le Mans, 72037

    Hervé MAILLARD, Dr, +33 (0)2 49 81 25 07, hmaillard@ch-lemans.fr

    Not yet recruiting

  • Centre Hospitalier Universitaire de Nice

    Nice, 06000

    Thierry PASSERON, Prof, 04 92 03 55 25, thierry.passeron@unice.fr

    Not yet recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059

    Juliette MAZEREEUW-HAUTIER, PROF, 05.67.77.81.41, mazereeuw.sec@chu-toulouse.fr

    Not yet recruiting

Other trials in France

About this study

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

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

Read the 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.

Conditions
Vitiligo
Being tested
Anifrolumab Infusion Product, Placebo
Keywords
anifrolumab, vitiligo, phototherapy, randomized
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anifrolumab Infusion ProductDrug

    Anifrolumab 300mg/month infusion for 36 weeks

  • PlaceboDrug

    Placebo once a month, infusion for 36 weeks

Study groups in NCT05917561
Study groupRoleWhat they receive
Phototherapy associated with active treatmentExperimentalAnifrolumab 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)
Receives: Drug: Anifrolumab Infusion Product
Phototherapy associated with placeboPlacebo comparatorPlacebo once a month infusion for 36 weeks + UVB TL01: 2 times a week during 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score with VASI score

    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.

    Measured: Week 36

Secondary outcomes (46)

  1. Score with VASI score

    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

    Measured: Week 12

  2. Score with VASI score Extent Score (VES)

    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.

    Measured: Week 24

  3. Score with VASI score Extent Score (VES)

    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.

    Measured: Week 48

  4. Face Vitiligo Aera Scoring Index (F-VASI) score

    Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 12

    Measured: Week 12

  5. Face Vitiligo Aera Scoring Index (F-VASI) score

    Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 24

    Measured: Week 24

  6. Face Vitiligo Aera Scoring Index (F-VASI) score

    Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 36

    Measured: Week 36

  7. Face Vitiligo Aera Scoring Index (F-VASI) score

    Mean variation in percentage of Face Vitiligo Area Scoring Index (F-VASI) score between baseline , week 48

    Measured: Week 48

  8. Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs

    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.

    Measured: Week 36

  9. Evaluation of score Vitiligo European Task Force (VETF)

    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).

    Measured: Week 12

  10. Evaluation of score Vitiligo European Task Force (VETF)

    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).

    Measured: Week 24

  11. Evaluation of score Vitiligo European Task Force (VETF)

    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).

    Measured: Week 36

  12. Evaluation of score of the Vitiligo Extent Score (VES)

    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.

    Measured: Week 48

  13. Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)

    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.

    Measured: Week 12

  14. Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)

    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.

    Measured: Week 24

  15. Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)

    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.

    Measured: Week 36

  16. Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)

    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.

    Measured: Week 48

  17. Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V)

    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.

    Measured: Week 12

  18. Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V)

    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.

    Measured: Week 24

  19. Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V)

    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.

    Measured: Week 36

  20. Evaluation of score of the Dermatology Life Quality Index (DLQI) Global Impression of Change-Vitiligo (PhGIC-V)

    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.

    Measured: Week 48

  21. Evaluation of the score of the Skindex 29

    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.

    Measured: Week 12

  22. Evaluation of the score of the Skindex 29

    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.

    Measured: Week 24

  23. Evaluation of the score of the Skindex 29

    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.

    Measured: Week 36

  24. Evaluation of the score of the Vitiligo Impact Patient Scale (VIP)

    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

    Measured: Week 48

  25. Evaluation of the score of the Vitiligo Impact Patient Scale (VIP)

    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

    Measured: Week 12

  26. Evaluation of the score of the Vitiligo Impact Patient Scale (VIP)

    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

    Measured: Week 24

  27. Evaluation of the score of the Vitiligo Impact Patient Scale (VIP)

    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

    Measured: Week 36

  28. Evaluation of the Vitiligo Noticeability Scale (VNS)

    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

    Measured: Week 12

  29. Evaluation of the Vitiligo Noticeability Scale (VNS)

    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

    Measured: Week 24

  30. Evaluation of the Vitiligo Noticeability Scale (VNS)

    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

    Measured: Week 36

  31. Evaluation of the Vitiligo Noticeability Scale (VNS)

    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

    Measured: Week 48

  32. Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V)

    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.

    Measured: Week 12

  33. Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V)

    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.

    Measured: Week 24

  34. Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V)

    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.

    Measured: Week 36

  35. Evolution of Physician's Global Impression of Change- Vitiligo (PhGIC-V)

    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.

    Measured: Week 48

  36. Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V)

    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.

    Measured: Week 12

  37. Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V)

    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.

    Measured: Week 24

  38. Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V)

    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.

    Measured: Week 36

  39. Evolution of Patient's Global Impression of Change- Vitiligo (PaGIC-V)

    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.

    Measured: Week 48

  40. Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA)

    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

    Measured: Week 12

  41. Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA)

    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

    Measured: Week 24

  42. Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA)

    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

    Measured: Week 36

  43. Evolution of the Total Physician Global Vitiligo Assessment (T-PhGVA)

    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

    Measured: Week 48

  44. Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.

    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.

    Measured: Day 1

  45. Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.

    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.

    Measured: Week 12

  46. Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.

    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.

    Measured: Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start15 Dec 2023
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917561
Sponsor's protocol ID
CHUBX 2022/03
Acronym
VITANI
Status last verified
Dec 2023
First submitted
31 May 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 25596811

  • 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.

    PubMed 27189851

  • 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.

    PubMed 25710794

  • 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.

    PubMed 15210457

  • 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.

    PubMed 28685247

  • 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.

    PubMed 24438589

  • 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.

    PubMed 28380264

  • 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.

    PubMed 32369451

  • 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.

    PubMed 28927891

  • 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.

    PubMed 31851795

  • 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.

    PubMed 21712822

  • 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.

    PubMed 17981025

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anifrolumab Infusion Product in people with Vitiligo, run by University Hospital, Bordeaux at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julien SENESCHAL, Prof (+33 (0)5 56 79 49 63, julien.seneschal@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score with VASI score (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05917561, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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