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Study on Baricitinib for Treating Children Aged 6 to 17 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 alopecia areata, a condition that causes hair loss, in children aged 6 to less than 18 years. The treatment being tested is called baricitinib, which is taken orally in the form of a tablet or oral suspension. The study aims to determine if different doses of baricitinib are more effective than a placebo in treating children with this condition.

Participants in the study will receive either a high dose or a low dose of baricitinib, or a placebo, over a period of time. The study will monitor the effects of the treatment on hair regrowth and assess the safety of baricitinib in children. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

The main goal of the study is to see if baricitinib can help reduce the severity of hair loss in children with alopecia areata. The study will track the percentage of participants who achieve a significant improvement in their condition. This research is important for understanding how effective baricitinib is in treating alopecia areata in a younger population and could lead to better treatment options in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, which is to evaluate the effectiveness and safety of baricitinib in treating children with alopecia areata, a condition causing hair loss.

    You will be randomly assigned to receive either a high dose, a low dose of baricitinib, or a placebo, which is a substance with no active medication.

  2. Step 2

    Medication administration

    You will take the medication orally in the form of a tablet or oral suspension. The exact dosage and frequency will be determined by the study team based on your specific group assignment.

    The duration of the medication administration will be specified by the study protocol, and you will be required to follow the instructions provided by the study team.

  3. Step 3

    Regular check-ups

    Throughout the trial, you will attend regular check-ups to monitor your health and the effects of the medication. These check-ups are essential to ensure your safety and to gather data on the medication's effectiveness.

    During these visits, various assessments will be conducted, including physical examinations and possibly laboratory tests.

  4. Step 4

    Completion of the trial

    At the end of the trial, you will have a final assessment to evaluate the overall impact of the treatment on your condition.

    The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

5 criteria

  • Must have had severe alopecia areata (AA) for at least 1 year. Alopecia areata is a condition that causes hair loss.
  • Current episode of AA must have lasted at least 6 months, with hair loss covering 50% or more of the scalp.
  • Current episode of severe to very severe AA must be less than 8 years long. If the AA has lasted 8 years or more, there must have been times when hair regrowth was observed, either naturally or with treatment, in the past 8 years.
  • Both males and females can participate.
  • Participants must be part of a vulnerable population, which means they may need special protection or care.

Who cannot join the trial?

8 criteria

  • Patients who have any other medical condition that might interfere with the study.
  • Patients who are currently taking any medication that could affect the study results.
  • Patients who have had a recent infection or illness that could impact their participation.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Baricitinib is a medication being tested in this clinical trial for its effectiveness in treating children with alopecia areata, a condition that causes hair loss. It works by blocking certain enzymes in the body that are involved in the immune response, which may help reduce inflammation and prevent hair loss. The trial aims to see if baricitinib can help improve hair growth in children with this condition.

What is already known about the treatment

Baricitinib – Baricitinib is a medication administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating alopecia areata, a condition that causes hair loss, particularly in children aged 6 to less than 18 years. The main therapeutic use of baricitinib in this context is to help regrow hair in individuals with this condition. At the molecular level, baricitinib works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process that leads to hair loss. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Alopecia areata – Alopecia areata is an autoimmune condition characterized by sudden, patchy hair loss on the scalp and other parts 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, while others may lose 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 disease can also progress to more severe forms, such as alopecia totalis, which involves complete loss of scalp hair, or alopecia universalis, which involves loss of all body hair. The course of the disease is unpredictable, with periods of hair loss and regrowth.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-502700-78-00Protocol codeI4V-MC-JAIOEstimated enrolment765 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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