Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Long-term safety and effectiveness study of ritlecitinib in children with severe alopecia areata who completed previous trials B7981027 or B7981031

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial studies the long-term effects of ritlecitinib in people with alopecia areata, a condition that causes hair loss. The study includes patients with severe forms of the disease, including alopecia totalis (complete loss of scalp hair) and alopecia universalis (loss of all body hair), who have previously participated in related studies.

The study uses ritlecitinib (also known as PF-06651600) in the form of hard capsules that are taken by mouth. Participants will receive either ritlecitinib at doses of 30 mg or 50 mg daily, or placebo. The treatment will continue for up to 36 months to evaluate how safe and effective the medication is over an extended period.

During the study, doctors will monitor hair growth on the scalp, eyebrows, and eyelashes. They will also track any changes in the participants' quality of life, emotional well-being, and behavior. The main focus is on checking the safety of the treatment and measuring how well it works in managing hair loss caused by alopecia areata.

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 evaluation

    You will begin the study after completing either study B7981027 or B7981031

    Your scalp hair loss will be evaluated using the SALT score (Severity of Alopecia Tool), which must show at least 50% hair loss

  2. Step 2

    Treatment assignment

    You will receive either ritlecitinib or a placebo in the form of hard capsules

    The medication will be taken by mouth

    Two possible doses are being studied: 30 mg or 50 mg

  3. Step 3

    Regular assessments

    Your scalp hair loss will be measured regularly using the SALT score

    Your eyebrows and eyelashes will be evaluated using special assessment tools (EBA and ELA)

    You will complete questionnaires about how you feel the treatment is working

    Your emotional well-being will be assessed through various questionnaires measuring anxiety and depression symptoms

  4. Step 4

    Long-term monitoring

    The study will continue until May 2030

    Regular check-ups will monitor any side effects or adverse reactions

    Your quality of life will be assessed using a special questionnaire for children with skin conditions

    At the end of the study (Month 36), cognitive abilities will be evaluated

Who can join the trial?

6 criteria

  • You must have previously completed either study B7981027 or study B7981031
  • You must have been diagnosed with alopecia areata (including complete loss of scalp hair or complete loss of body hair)
  • If you participated in study B7981031, you must have at least 50% scalp hair loss (measured by something called a SALT score) at both screening and baseline visits
  • You can be either male or female
  • You must be a child or adolescent (pediatric patient)
  • You must have completed all required visits and procedures in your previous study (either B7981027 or B7981031)

Who cannot join the trial?

15 criteria

  • Previous severe allergic reactions to any medications similar to ritlecitinib or other study medications
  • Current participation in other clinical trials or use of investigational drugs within 30 days before this study
  • Serious or uncontrolled medical conditions that could interfere with study participation
  • Current active infections that require treatment
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Pregnant or breastfeeding women, or those planning pregnancy during the study period
  • Significant liver problems or abnormal liver function tests
  • Severe kidney disease requiring dialysis
  • Untreated or poorly controlled high blood pressure
  • History of serious heart conditions
  • Current or recent serious infections, including tuberculosis or hepatitis
  • Use of medications that could interact with the study drug
  • Mental health conditions that could affect ability to follow study procedures
  • Drug or alcohol abuse within the past 6 months
  • Blood disorders that could affect safety during the study
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ritlecitinib is a medication being studied for treating severe alopecia areata, which is a condition that causes hair loss. This medication is being tested for its long-term safety and effectiveness in pediatric patients. It works by targeting specific proteins in the body that are involved in the immune system response that leads to hair loss.

What is already known about the treatment

Ritlecitinib - An oral medication being investigated for the treatment of severe alopecia areata, particularly in pediatric patients. This kinase inhibitor works by targeting specific enzymes involved in the immune response that causes hair loss, helping to regulate the body's immune system and potentially promote hair regrowth. The drug belongs to the class of Janus kinase (JAK) inhibitors and is currently being studied in clinical trials to evaluate its long-term safety and effectiveness. Ritlecitinib is administered as a tablet taken by mouth, and represents a potential new therapeutic option for patients with severe autoimmune-related hair loss who have not responded adequately to other treatments.

Investigated diseases

Alopecia areata - A condition where the immune system mistakenly attacks hair follicles, causing hair loss in round or oval patches. The hair loss typically begins suddenly and can occur anywhere on the body, but most commonly affects the scalp. It can affect people of all ages and genders, with varying patterns of hair loss ranging from small patches to complete loss of scalp hair. The condition may cause changes in the fingernails and toenails, such as tiny dents or ridges. While hair can regrow on its own, the pattern and timeline of regrowth varies from person to person.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-515439-31-00Protocol codeB7981028Estimated enrolment140 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.