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Severe Alopecia AreataPhase 3B7981028NCT07029828

A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

A Phase 3 study testing Ritlecitinib higher dose and Ritlecitinib lower dose in people with Severe Alopecia Areata, run by Pfizer at 67 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss. Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Severe Alopecia Areata
What is being tested?
Ritlecitinib higher dose and Ritlecitinib lower dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
67 sitesin 9 countries
Study dates
10 Sep 2025to 26 Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants with alopecia areata (AA) (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the studies B7981027 or B7981031.
  • For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.

Who cannot join

  • Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028
  • During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
  • Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028.
  • Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028
  • During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
  • Any present malignancies or history of malignancies or lymphoproliferative disorders.
  • Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • -

Trial locations and contacts

67 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

67 sites in 9 countries

United States23 sites, 23 recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

    Recruiting

  • University of New Mexico-IDS Pharmacy

    Albuquerque, New Mexico, 87106

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Dell Children's Medical Center

    Austin, Texas, 78723

    Not yet recruiting

  • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic

    Charleston, South Carolina, 29425

    Recruiting

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

    Recruiting

  • 3A Research

    El Paso, Texas, 79902

    Recruiting

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

    Recruiting

  • University of California~ Irvine

    Irvine, California, 92697

    Recruiting

  • Kindred Hair and Skin Center

    Marriottsville, Maryland, 21104

    Not yet recruiting

  • Pediatric Skin Research

    Miami, Florida, 33156

    Recruiting

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226

    Not yet recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Not yet recruiting

  • Ear, Nose & Throat Consultants, LLC

    Omaha, Nebraska, 68144

    Recruiting

  • Skin Specialists, PC dba Schlessinger MD

    Omaha, Nebraska, 68144

    Recruiting

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

    Recruiting

  • Northwest Dermatology Institute

    Portland, Oregon, 97210

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

    Recruiting

  • Southern California Clinical Research

    Santa Ana, California, 92701

    Recruiting

  • Endeavor Health Clinical Operations

    Skokie, Illinois, 60077

    Recruiting

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

    Recruiting

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328

    Recruiting

Other trials in United States

China10 sites, 10 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Recruiting

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

    Recruiting

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100176

    Recruiting

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

    Recruiting

  • Chengdu Women and Children Center Hospital

    Chengdu, Sichuan, 610091

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510140

    Recruiting

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006

    Recruiting

  • Hangzhou Third Hospital

    Hangzhou, Zhejiang, 310009

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

Other trials in China

Poland10 sites, 10 recruiting

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

    Recruiting

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.

    Krakow, Lesser Poland Voivodeship, 30-003

    Recruiting

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, Łódź Voivodeship, 90-436

    Recruiting

  • DERMEDIC Iwona Zdybska

    Lublin, Lublin Voivodeship, 20-607

    Recruiting

  • Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie

    Rzeszów, 35-055

    Recruiting

  • Klinika Osipowicz & Turkowski

    Warsaw, Masovian Voivodeship, 00-716

    Recruiting

  • Provita Poliklinika

    Warsaw, Masovian Voivodeship, 02-647

    Recruiting

  • Klinika Ambroziak Dermatologia

    Warsaw, Masovian Voivodeship, 02-953

    Recruiting

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962

    Recruiting

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, Lower Silesian Voivodeship, 50-566

    Recruiting

Other trials in Poland

France7 sites, 7 recruiting

  • Hospices Civils de Lyon - CIC - Hopital Louis Pradel

    Bron, 69500

    Recruiting

  • Hospices Civils de Lyon - Hopital Femme Mere Enfant

    Bron, 69500

    Recruiting

  • CHU de Dijon Bourgogne

    Dijon, 21079

    Recruiting

  • GHICL - Service d'investigation - Recherche clinique

    Lille, 59000

    Recruiting

  • Hôpital Saint Vincent de Paul

    Lille, 59020

    Recruiting

  • Centre Hospitalier Universitaire de Nice

    Nice, 06202

    Not yet recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

    Toulouse, 31400

    Not yet recruiting

Other trials in France

Japan5 sites, 5 recruiting

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

    Recruiting

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

    Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Recruiting

Other trials in Japan

Czechia4 sites, 4 recruiting

  • Fakultní Nemocnice Brno

    Brno, 613 00

    Not yet recruiting

  • Fakultni Nemocnice Plzen

    Pilsen, 30599

    Recruiting

  • Prof. MUDr. Petr Arenberger, DrSc., MBA

    Prague, 11000

    Not yet recruiting

  • Fakultni nemocnice Bulovka

    Praha 8 - Libeň, 180 81

    Recruiting

Other trials in Czechia

United Kingdom4 sites, 4 recruiting

  • Royal Alexandra Children's Hospital

    Brighton, EAST SUSSEX, BN2 5BE

    Recruiting

  • University Hospitals Sussex NHS Foundation Trust (UHSussex)

    Brighton, BN2 1ES

    Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London, GREATER LONDON, SE1 7EH

    Recruiting

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, GREATER LONDON, SW10 9NH

    Recruiting

Other trials in United Kingdom

Italy2 sites, 2 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S: Orsola

    Bologna, BOLOGNA, 40138

    Not yet recruiting

  • Asst Spedali Civili Di Brescia

    Brescia, BRESCIA, 25123

    Not yet recruiting

Other trials in Italy

Spain2 sites, 2 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, BARCELONA, 08025

    Not yet recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

    Recruiting

Other trials in Spain

About this study

Official title: A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.

This study is seeking participants who have:

Read more
  • previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).
  • at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).
  • received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.

All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.

Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.

The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.

The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.

Read the detailed description

Study B7981028 is a Phase 3 long-term, double-blind extension study to evaluate the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA) who have completed previous ritlecitinib studies B7981031 or B7981027 and are eligible to enroll for B7981028 study.

The primary objective of this study is to evaluate the long-term safety and tolerability of ritlecitinib in pediatric participants with severe AA who have completed the studies B7981027 or B7981031. The secondary objectives of this study are to evaluate the long-term efficacy of ritlecitinib, durability of response and effect of ritlecitinib on patient centered outcomes.

All participants in this study will receive ritlecitinib higher or lower dose for up to an additional 3 years following completion of either of the prior parent studies. Participants who received higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in Study B7981028. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will be randomized at a 1:1 ratio to receive higher or lower dose of ritlecitinib in Study B7981028.

At least 140 participants evaluable for primary analysis will be enrolled in Study B7981028.

Participants will be evaluated for treatment continuation criteria at Months 3 and 6 (for those who were previously assigned to active treatment in parent Study B7981027) and at Months 9 and 12 in Study B7981028 (for those who previously completed Study B7981031 or were assigned to placebo in the parent Study B7981027). Ritlecitinib treatment will be discontinued for any participant who does not meet the study treatment continuation criteria.

Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.

The efficacy assessments include Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments. Patient reported outcomes including Patient's Global Impression of Change (PGI-C), Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Anxiety Short Form 8a and Depressive Symptoms Short Form 6a, Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), and modified Children's Dermatology Life Quality Index (CDLQI) will be assessed throughout the study.

Being tested
Ritlecitinib higher dose, Ritlecitinib lower dose
Keywords
Alopecia Areata, Children, Ritlecitinib, Long-term extension study
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ritlecitinib higher doseDrug

    Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

  • Ritlecitinib lower doseDrug

    Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Study groups in NCT07029828
Study groupRoleWhat they receive
Ritlecitinib higher doseExperimentalParticipants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
Receives: Drug: Ritlecitinib higher dose
Ritlecitinib lower doseExperimentalParticipants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
Receives: Drug: Ritlecitinib lower dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (AEs).

    Measured: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).

  2. Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.

    Measured: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).

Secondary outcomes (10)

  1. Proportion of participants achieving absolute Severity of Alopecia Tool (SALT) score ≤10.

    Measured: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  2. Proportion of participants achieving absolute SALT score ≤20.

    Measured: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  3. Change from baseline (CFB) in SALT score.

    Measured: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  4. Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score in participants with an abnormal EBA at baseline.

    Measured: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  5. Proportion of participants achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score in participants with an abnormal ELA at baseline.

    Measured: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  6. Proportion of participants achieving Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved".

    Measured: Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  7. CFB in PROMIS Parent Proxy Anxiety Symptoms T-score.

    Measured: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  8. CFB in Behavior Rating Inventory of Executive Function (BRIEF®2) T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)).

    Measured: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  9. CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score.

    Measured: Baseline, Months 3,6,9,12,15,18,21,24,27,30,33 and 36.

  10. CFB in Wechsler Intelligence Scale for Children® Fifth Edition (WISC-V).

    Measured: Baseline, Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study start10 Sep 2025
  3. Primary completion26 Jun 2030 (estimated)
  4. Study completion26 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07029828
Sponsor's protocol ID
B7981028
Other IDs
2024-515439-31-00
Acronym
B7981028
Status last verified
Oct 2026
First submitted
11 Jun 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ritlecitinib higher dose and Ritlecitinib lower dose in people with Severe Alopecia Areata, run by Pfizer at 67 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, China, Poland, France, Japan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (AEs). (time frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07029828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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