Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo
NCT ID: NCT05917561
Last Updated: 2023-12-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-15
Study Completion Date
2026-05-01
Brief Summary
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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
Detailed Description
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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
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Vitiligo
Keywords
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anifrolumab
vitiligo
phototherapy
randomized
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
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.
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.
Study Groups
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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)
Group Type
EXPERIMENTAL
Anifrolumab Infusion Product
Intervention Type
DRUG
Anifrolumab 300mg/month infusion for 36 weeks
Phototherapy associated with placebo
Placebo once a month infusion for 36 weeks + UVB TL01: 2 times a week during 24 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo once a month, infusion for 36 weeks
Interventions
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Anifrolumab Infusion Product
Anifrolumab 300mg/month infusion for 36 weeks
Intervention Type
DRUG
Placebo
Placebo once a month, infusion for 36 weeks
Intervention Type
DRUG
Eligibility Criteria
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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)
* 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.
* 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)
* 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.
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
* 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.
* 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:
1. Hepatitis B surface antigen, OR
2. 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.
* 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
* 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.
* 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:
1. Hepatitis B surface antigen, OR
2. 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AstraZeneca
INDUSTRY
Sponsor Role
collaborator
University Hospital, Bordeaux
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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CHU de Bordeaux
Bordeaux, , France
Site Status
RECRUITING
Centre Hospitalier Régional Le Mans
Le Mans, , France
Site Status
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Nice
Nice, , France
Site Status
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
Site Status
NOT_YET_RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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JULIEN SENESCHAL, PROF
Role: primary
Hervé MAILLARD, Dr
Role: primary
Thierry PASSERON, Prof
Role: primary
Juliette MAZEREEUW-HAUTIER, PROF
Role: primary
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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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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BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX 2022/03
Identifier Type: -
Identifier Source: org_study_id