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Study on the Effects of Ritlecitinib in Patients Aged 12 and Older with Alopecia Areata

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Ritlecitinib Tosilate in people aged 12 and older who have Alopecia Areata. Alopecia Areata is a condition that causes hair loss, often in patches, on the scalp and other parts of the body. The study will test two different doses of Ritlecitinib Tosilate, 50 mg and 100 mg, taken once daily. The purpose of the study is to see how effective these doses are in helping hair regrow on the scalp.

Participants in the study will be randomly assigned to receive either Ritlecitinib Tosilate or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of 48 weeks, during which participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their progress and any changes in their hair growth.

The main goal is to compare the effects of the 100 mg dose of Ritlecitinib Tosilate with the placebo in terms of hair regrowth. The study will also look at how participants feel about their hair growth and any improvements they notice. This research aims to provide more information about the safety and effectiveness of Ritlecitinib Tosilate for treating Alopecia Areata.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be informed about the purpose and procedures of the trial. The study aims to evaluate the effectiveness of two doses of ritlecitinib in individuals aged 12 and older with alopecia areata, a condition characterized by hair loss.
Step 2
Initial assessment
Participants will undergo an initial assessment to confirm eligibility. This includes verifying a clinical diagnosis of alopecia areata with at least 50% hair loss on the scalp, as measured by the SALT score, and ensuring no significant hair regrowth in the past six months.
Step 3
Randomization
Eligible participants will be randomly assigned to receive either ritlecitinib 50 mg, ritlecitinib 100 mg, or a placebo. The medication will be administered orally in the form of a hard capsule.
Step 4
Medication administration
Participants will take the assigned medication once daily. The duration of the treatment phase is not specified in the provided data.
Step 5
Monitoring and follow-up
Throughout the study, participants will be monitored for any changes in their condition and any side effects. Regular follow-up visits will be scheduled to assess the progress of hair regrowth and overall health.
Step 6
Evaluation of results
The primary goal is to evaluate the regrowth of scalp hair at Week 24, using the SALT score. Secondary outcomes include participant-reported improvements in their condition.

Who can join the trial?

5 criteria

Must be 18 years or older at the time of screening. Adolescents aged 12 to under 18 years can also participate if allowed by local regulations.
Must have a clinical diagnosis of alopecia areata (AA), which is a condition causing hair loss, with no other reasons for hair loss.
Must have 50% or more hair loss on the scalp, as measured by a method called SALT, and no significant hair regrowth in the last 6 months. SALT is a way to measure the amount of hair loss.
Photographs of the scalp taken at screening must be submitted for verification of the SALT score and hair loss due to AA. Participants can only join the study after this verification is confirmed.
The current episode of hair loss must have started 10 years ago or less.

Who cannot join the trial?

8 criteria

Patients with any other autoimmune disease that affects hair loss cannot participate. An autoimmune disease is when the body's defense system attacks its own cells.
Patients who have had a serious infection in the past 6 months are not eligible. A serious infection is one that requires hospitalization or intravenous antibiotics.
Patients who are currently taking medications that suppress the immune system cannot join. These medications lower the body's ability to fight infections.
Patients with a history of cancer in the past 5 years, except for certain skin cancers, are excluded. Cancer is a disease where cells grow uncontrollably.
Patients who have participated in another clinical trial in the last 30 days are not allowed to join. A clinical trial is a research study to test new treatments.
Pregnant or breastfeeding women cannot participate. Breastfeeding is feeding a baby with milk from the mother's breast.
Patients with a known allergy to the study medication or its ingredients are excluded. An allergy is a reaction by the immune system to something that is usually harmless.
Patients with uncontrolled medical conditions that could interfere with the study are not eligible. Uncontrolled means the condition is not being managed well with treatment.

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Verified sites

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Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Verified
Fakultni Nemocnice Plzen
Plzen, Czechia

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Investigated drugs

Ritlecitinib is a medication being studied for its potential to help people with alopecia areata, a condition that causes hair loss. This medication is taken once a day and is being tested to see if it can help regrow hair on the scalp. The study is looking at how safe and effective this medication is for both adults and adolescents who are 12 years old and older. By comparing it to a placebo, researchers hope to understand how well it works in helping people with this condition.

What is already known about the treatment

Ritlecitinib – Ritlecitinib is a medication taken orally in the form of a pill, typically administered once daily. It is currently being studied in clinical trials for its effectiveness in treating alopecia areata, a condition that causes hair loss. The main goal of the medication is to help regrow scalp hair in individuals affected by this condition. Ritlecitinib works by targeting specific pathways in the immune system that are involved in the process of hair loss, helping to restore normal hair growth. It is classified as a Janus kinase (JAK) inhibitor, which means it interferes with certain enzymes that play a role in inflammation and immune responses.

Investigated diseases

Alopecia areata – Alopecia areata is an autoimmune condition characterized by sudden, patchy hair loss on the scalp and other areas of the body. The immune system mistakenly attacks hair follicles, leading to hair falling out in small, round patches. The progression of the disease can vary greatly among individuals, with some experiencing only a few patches of hair loss and others losing more extensive areas of hair. In some cases, the hair may regrow on its own, while in others, the condition may persist or worsen over time. The exact cause of alopecia areata is not fully understood, but it is believed to involve a combination of genetic and environmental factors. The condition can affect people of all ages and genders.