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Study of ritlecitinib for treating severe alopecia areata in children aged 6 to under 12 years

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What is this trial about?

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

This clinical trial focuses on children aged 6 to under 12 years who have severe alopecia areata, a condition that causes hair loss on the scalp. The study aims to evaluate how well a medication called ritlecitinib (also known as PF-06651600) works compared to placebo in helping regrow lost scalp hair in children with this condition.

The study medication ritlecitinib comes in the form of hard capsules and will be taken by mouth. Participants will receive either ritlecitinib at doses of 30 mg or 50 mg per day, or a placebo. The treatment period will last for 24 weeks, which is approximately 6 months.

During the study, researchers will monitor how well the medication works by measuring hair regrowth on the scalp. They will also track any side effects that may occur. The study will collect information about how the treatment affects the participants' daily activities and emotional well-being. Blood samples will be taken to measure the amount of medication in the body at specific times during the study.

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

    Initial assessment

    Your eligibility for the study will be evaluated based on your age (between 6 and 12 years) and hair loss condition

    You must have at least 50% scalp hair loss due to alopecia areata and no hair regrowth in the past 12 months

    Previous unsuccessful hair loss treatments will be reviewed

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either ritlecitinib capsules or placebo capsules

    The capsules need to be taken by mouth daily

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    24-week treatment period

    Regular check-ups will monitor your progress

    Your scalp hair growth will be measured using the SALT score (a method to measure hair loss)

    Blood samples will be collected at week 4 or 8 to measure medication levels

    Your doctor will assess any changes in your eyebrows and eyelashes if applicable

  4. Step 4

    Monitoring and evaluation

    Your health will be monitored for any side effects throughout the study

    You and your parent/guardian will complete questionnaires about how you feel and how the hair loss affects your daily life

    The main goal is to achieve a SALT score of 10 or less by week 24, indicating significant hair regrowth

    The study team will evaluate how well you tolerate taking the medication

Who can join the trial?

9 criteria

  • Must be between 6 and 11 years old when starting the study
  • Must have been diagnosed with alopecia areata (a condition causing hair loss in patches) with at least 50% scalp hair loss
  • The hair loss must have been present for at least 12 months without any signs of natural hair regrowth
  • Must have previously tried other treatments for hair loss that did not work, such as:
    • Topical treatments (medicines applied directly to the scalp)
    • Other medications
    • Hair pieces or wigs
    • Both boys and girls can participate in the study
    • The scalp hair loss must be measured using a SALT score (Severity of Alopecia Tool) of 50 or higher at both initial screening and baseline visits
    • The condition can include complete hair loss on the scalp (alopecia totalis) or complete hair loss on the entire body (alopecia universalis)

Who cannot join the trial?

14 criteria

  • People who have a serious or active infection, including tuberculosis or hepatitis B
  • Those with a compromised immune system (weakened ability to fight infections)
  • Individuals who have received live vaccines within 4 weeks before starting the study
  • People with significant heart problems or uncontrolled high blood pressure
  • Those with severe kidney or liver problems
  • People who have or had any type of cancer in the past 5 years (except successfully treated skin cancer)
  • Pregnant or breastfeeding women
  • People taking certain medications that could interact with the study drug
  • Those who participated in another clinical trial within the past 30 days
  • People with a history of serious allergic reactions to medications
  • Individuals with untreated thyroid disease
  • Those with a history of blood disorders
  • People who abuse drugs or alcohol
  • Those who cannot follow the study protocol or attend regular visits
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Investigated drugs

Ritlecitinib is a medication being studied for treating severe alopecia areata in children. It works by targeting specific enzymes in the body that are involved in the immune response, which may help reduce inflammation and promote hair regrowth. This medication is being tested to see if it can help children who have lost significant amounts of scalp hair due to alopecia areata, an autoimmune condition where the body's immune system attacks hair follicles. Placebo is also used in this trial as a control substance to compare with the active medication.

What is already known about the treatment

Ritlecitinib - An investigational oral medication being studied for the treatment of severe alopecia areata, particularly in pediatric patients aged 6 to 12 years. This drug belongs to the class of Janus kinase (JAK) inhibitors and works by modulating the immune system response that causes hair loss in alopecia areata. Ritlecitinib functions by blocking specific enzymes involved in the inflammatory pathway that leads to hair follicle damage, potentially promoting hair regrowth. The medication is currently undergoing Phase 3 clinical trials to evaluate its efficacy and safety in treating severe cases of autoimmune-related hair loss.

Investigated diseases

Alopecia areata - A condition where the immune system attacks hair follicles, causing patches of hair loss on the scalp and sometimes other parts of the body. The hair loss typically occurs in round or oval patches, and the affected skin appears smooth and normal. The condition can develop suddenly over a few days and may affect people of any age or gender. The hair follicles remain alive during this process, which means hair can potentially regrow. The pattern and extent of hair loss can vary significantly between individuals, from small patches to complete loss of scalp hair.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-515438-33-00Protocol codeB7981027Estimated enrolment225 patientsSponsorPfizer Inc.

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