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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Fakultni Nemocnice Bulovka Prague Czechia
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Labderm Essence Sp. z o.o. Ozarowice Poland
Fakultni Nemocnice Plzen Plzen Czechia
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Fakultni Nemocnice Brno Brno Czechia
Centre Hospitalier Universitaire De Nice Nice France
Hopitaux Drome Nord Romans-Sur-Isere France
Centre Hospitalier Lyon Sud Pierre Benite France
Universita Degli Studi Di Brescia Brescia Italy
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
Prfzbwt Phwvnnqdmwm Sjn z ousl Warsaw Poland
Nthn Swjvpzrb Oivzosb Doqcxwjjnsxeqmb Dvswvg Bialystok Poland
Cpwcfu Hxhwzszsjlm Uyzqkrbmiuahh Dx Dphfk Dijon France
Phrcxgwmr Iuhksksx Mhqjucmb Mdqxenqfecxk Sslpu Wweumblxsgtg I Aebdlagsheato Warsaw Poland
Apnhsyp Uwhip Stmoyhxjg Lpftzw Dq Brxcpwo Bologna Italy
Pfmpsmq Sgc z ojgp Katowice Poland
Htasknig De Lh Sppwc Chfr I Sgnu Pvm Barcelona Spain
Zuncuoy Mlh Slt z oimd Lublin Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
10.05.2026
France France
Not yet recruiting
10.05.2026
Italy Italy
Not yet recruiting
10.05.2026
Poland Poland
Not yet recruiting
10.05.2026
Spain Spain
Not yet recruiting
10.05.2026

Trial locations

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.

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 ID:
2024-515439-31-00
Protocol code:
B7981028
Trial Phase:
Therapeutic confirmatory (Phase III)

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