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Efficacy and tolerability of the combination of anifrolumab (300 mg IV) and phototherapy versus phototherapy in adults with progressive vitiligo
EU CTIS ID: 2024-512041-17-00
What this study is testing
To evaluate the efficacy of the combination of anifrolumab intravenous (IV) every four weeks + UVB TL01 (twice a week) by the evaluation of the percentage of skin repigmentation after 36 weeks of treatment using the VASI score in the experimental group receiving anifrolumab + UVB TL01.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject male or female aged ≥ 18 years and ≤ 65 years
- Subject with body weight > or = 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
- Affiliated or beneficiary of the French Social Security
You likely can't join if
- Segmental or mixed vitiligo
- 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. Note: Patients may not be rescreened until at least 4 weeks after the date of their previous screen failure and at least 2 weeks after resolution of the infection.
- 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.
- 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).
See the full eligibility criteria
- Subject male or female aged ≥ 18 years and ≤ 65 years
- Subject with body weight > or = 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
- Affiliated or beneficiary of 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): phototherapy.
- Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization and throughout the study: systemic steroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine.
- Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization and throughout the study: • TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus) • Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) • Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments.
- Segmental or mixed vitiligo
- 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. Note: Patients may not be rescreened until at least 4 weeks after the date of their previous screen failure and at least 2 weeks after resolution of the infection.
- 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.
- 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).
- Current alcohol, drug, or chemical abuse.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.