Study on Anifrolumab and Phototherapy for Adults with Progressive Vitiligo

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for vitiligo, a condition that causes patches of skin to lose their color. The study involves adults with progressive, non-segmental vitiligo, which means the condition affects both sides of the body symmetrically. The treatment being tested is a combination of a medication called anifrolumab and a type of light therapy known as phototherapy. Anifrolumab, also known by its code name MEDI-546, is given through an intravenous infusion every four weeks. Phototherapy involves exposing the skin to ultraviolet B (UVB) light twice a week.

The purpose of the study is to evaluate how effective this combination treatment is in helping the skin regain its color over a period of 36 weeks. Participants will be randomly assigned to receive either the combination of anifrolumab and phototherapy or phototherapy alone. The study will monitor changes in skin pigmentation using a scoring system called the Vitiligo Area Scoring Index (VASI). This will help researchers understand how well the treatment works in repigmenting the skin.

Throughout the study, the safety and tolerability of the treatment will be assessed through clinical and biological exams. Participants will have regular check-ups to monitor their progress and any potential side effects. The study aims to provide valuable insights into the potential benefits of combining anifrolumab with phototherapy for individuals with vitiligo.

1 Joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, weight, and diagnosis of non-segmental vitiligo.

Informed consent is required, and certain medications must be discontinued prior to participation.

2 Initial assessment

An initial assessment is conducted to establish baseline measurements, including the Vitiligo Area Scoring Index (VASI) score.

Blood and skin samples may be collected for further analysis.

3 Treatment phase

The treatment involves receiving anifrolumab 300 mg through an intravenous infusion every four weeks.

In addition to the medication, phototherapy using UVB TL01 is administered twice a week.

This phase lasts for 36 weeks, during which the effectiveness of the treatment is monitored.

4 Regular evaluations

Regular evaluations occur at weeks 12, 24, 36, and 48 to assess changes in vitiligo using various scoring systems.

These evaluations include clinical and biological exams to ensure safety and tolerability.

5 Final assessment

At the end of the treatment period, a final assessment is conducted to measure the overall effectiveness of the treatment.

The primary focus is on the change in the VASI score from the beginning to the end of the study.

Who Can Join the Study?

Must be a male or female aged between 18 and 65 years.
Must weigh more than or equal to 40 kilograms.
Must have a diagnosis of non-segmental vitiligo, which is a type of skin condition where patches of skin lose their color, affecting more than 5% of the body, not including hands and feet.
The vitiligo must be active, meaning there are new patches or old patches have grown in the last 6 months. This can be confirmed by a special light examination called Wood’s lamp examination.
Must be able to read, understand, and sign a consent form, either electronically or on paper.
Must be affiliated with or a beneficiary of the French Social Security system.
Must agree to stop using certain treatments like phototherapy for at least 4 weeks before starting the study.
Must agree to stop using certain medications like systemic steroids (medications that reduce inflammation), methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine for at least 4 weeks before starting and throughout the study.
Must agree to stop using certain topical treatments (applied to the skin) for at least 2 weeks before starting and throughout the study. These include TCS (topical corticosteroids), topical immune modulators like tacrolimus or pimecrolimus, topical phosphodiesterase type 4 (PDE-4) inhibitors like crisaborole, and topical JAK inhibitors like tofacitinib or ruxolitinib.

Who Cannot Join the Study?

Patients with a type of vitiligo called non-segmental vitiligo that affects more than 5% of their body, not counting the hands and feet, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.12.2023

Trial locations

Investigated drugs:

Anifrolumab

Anifrolumab is a medication given through an intravenous (IV) infusion every four weeks. It is being studied for its potential to help with skin repigmentation in adults with progressive vitiligo. In this trial, it is used in combination with phototherapy to see if it can improve the treatment outcomes.

Phototherapy (UVB TL01) is a type of light therapy used twice a week in this study. It involves exposing the skin to ultraviolet B (UVB) light, which can help stimulate skin repigmentation in people with vitiligo. In this trial, it is combined with anifrolumab to assess the effectiveness of the combined treatment.

Investigated diseases:

Vitiligo

Vitiligo – Vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on various parts of the body. It occurs when the cells responsible for skin color, melanocytes, are destroyed or stop functioning. The condition can affect any part of the skin, but it commonly appears on the face, neck, hands, and skin folds. Non-segmental vitiligo, the most common type, often presents symmetrically on both sides of the body. The progression of vitiligo is unpredictable, with some people experiencing slow changes over many years, while others may see rapid changes. The extent of pigment loss can vary, and the condition may stabilize or continue to spread over time.

Trial ID:

2024-512041-17-00

Protocol code:

CHUBX 2022/03

NCT ID:

NCT05917561

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Anifrolumab and Phototherapy for Adults with Progressive Vitiligo

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?