Severe Alopecia AreataPhase 3B7981027NCT07029711
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years 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 83 sites in 9 countries.
Trial summary
The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss. This study is seeking participants who have: at least 50% scalp hair loss due to alopecia areata. Read more about this study
- Who is it for?
- Ages 6 to 11 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?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 83 sitesin 9 countries
- Study dates
- 31 Jul 2025to 6 Jan 2027
- Phase
- Phase 3
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
- For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)
- Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.
Who cannot join
- Other (non-AA) types of alopecia, including any known congenital cause of AA.
- Pre-existing hearing loss.
- Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
- Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.
Trial locations and contacts
83 sites in 9 countries.
83 sites in 9 countries
United States31 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102
University of New Mexico-IDS Pharmacy
Albuquerque, New Mexico, 87106
Children's Hospital Colorado
Aurora, Colorado, 80045
Dell Children's Medical Center
Austin, Texas, 78723
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, 29425
Endeavor Health Audiology -CHICAGO
Chicago, Illinois, 60625
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
3A Research - West Location
El Paso, Texas, 79902
Endeavor Health Behavioral Health - Evanston
Evanston, Illinois, 60201
Endeavor Health Clinical Operations
Evanston, Illinois, 60201
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
UCI Dermatology Clinical Research
Irvine, California, 92697
Endeavor Health Audiology -LAKE BLUFF
Lake Bluff, Illinois, 60044
Kindred Hair and Skin Center
Marriottsville, Maryland, 21104
Pediatric Skin Research
Miami, Florida, 33156
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Endeavor Health Audiology-NORTHBROOK
Northbrook, Illinois, 60062
Ear, Nose and Throat Consultants, LLC
Omaha, Nebraska, 68144
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, 68144
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
Papillion, Nebraska, 68046
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Northwest Dermatology Institute
Portland, Oregon, 97210
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Southern California Clinical Research
Santa Ana, California, 92701
Endeavor Health Audiology-SKOKIE
Skokie, Illinois, 60076
Endeavor Health Clinical Operations
Skokie, Illinois, 60077
Endeavor Health Lab Services - Old Orchard
Skokie, Illinois, 60077
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Michigan Dermatology Institute
Waterford, Michigan, 48328
China14 sites
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100192
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730
China-Japan Friendship Hospital
Beijing, 100029
Hunan Children's Hospital
Changsha, Hunan, 410007
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Chengdu Women and Children Center Hospital
Chengdu, Sichuan, 610091
The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510140
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009
Kunming Children's hospital
Kunming, Yunnan, 650103
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Children's Hospital
Shanghai, 200062
Poland14 sites
Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
Bialystok, Podlaskie Voivodeship, 15-453
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
Provita Sp. z o.o.
Katowice, Silesian Voivodeship, 40-611
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.
Krakow, Lesser Poland Voivodeship, 30-002
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, 90-436
DERMEDIC Iwona Zdybska
Lublin, Lublin Voivodeship, 20-607
Labderm Essence Sp. Z o.o.
Ossy, Silesian Voivodeship, 42-624
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie
Rzeszów, 35-055
Klinika Osipowicz & Turkowski
Warsaw, Masovian Voivodeship, 00-716
Państwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, 02-507
Provita Poliklinika
Warsaw, Masovian Voivodeship, 02-647
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, 02-953
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, 02-962
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, 50-566
France7 sites
Hospices Civils de Lyon - CIC - Hopital Louis Pradel
Bron, 69500
Hospices Civils de Lyon - Hopital Femme Mere Enfant
Bron, 69500
CHU de Dijon Bourgogne
Dijon, 21079
GHICL - Service d'investigation - Recherche clinique
Lille, 59000
GHICL - Hôpital Saint Vincent de Paul
Lille, 59020
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2
Nice, 06200
Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey
Toulouse, 31400
Japan5 sites
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520
Osaka Metropolitan University Hospital
Osaka, 545-8586
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Czechia4 sites
Fakultní Nemocnice Brno
Brno, 613 00
Fakultní nemocnice Plzeň
Pilsen, 30599
Prof. MUDr. Petr Arenberger, DrSc., MBA
Prague, 11000
Fakultní nemocnice Bulovka
Praha 8 - Libeň, 180 81
Italy3 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Asst Spedali Civili Di Brescia
Brescia, 25123
Policlinico "G. Rodolico
Catania, 95123
United Kingdom3 sites
Royal Alexandra Children's Hospital
Brighton, EAST Sussex, BN2 5BE
Guy's and St Thomas' NHS Foundation Trust
London, Greater London, SE1 7EH
Chelsea and Westminster Hospital NHS Foundation Trust
London, Greater London, SW10 9NH
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss.
This study is seeking participants who have:
Read more
- at least 50% scalp hair loss due to alopecia areata.
- received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
- history of clinical response failure to alopecia areata treatment (for children in EU/UK only).
All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo.
The study medicine is a capsule that is taken by mouth. It is taken once each day at home.
The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective.
Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.
Read the detailed description
Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to <12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritlecitinib and to evaluate the effect of ritlecitinib on patient centered outcomes.
This study will have 3 treatment arms, including 2 ritlecitinib dosage levels (higher and lower doses) and 1 placebo arm. The participants will be assessed for study eligibility at the screening visit after informed consent/assent is obtained (as applicable).
Participants will receive study medication for a duration of 24 weeks.
At least 225 participants will be enrolled in the study. At least 30% of total study population will be recruited from Europe.
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), Alopecia Areata Patient Priority Outcomes (AAPPO), 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. Pharmacokinetics of ritlecitinib will be evaluated using sparse sampling.
Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.
Participants completing the 24-week treatment period of the study may have the option to enter the long-term extension (LTE) Study B7981028, if the eligibility criteria are met. Participants who complete the 24-week treatment period of the study but who are ineligible for the LTE study will undergo a 4-week off-treatment follow-up period.
- Conditions
- Severe Alopecia Areata
- Being tested
- Ritlecitinib higher dose, Ritlecitinib lower dose, Placebo
- Keywords
- Alopecia areata, Children, Ritlecitinib
- 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
Also called Active Treatment
Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.
Ritlecitinib lower doseDrug
Also called Active Treatment
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
PlaceboDrug
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
| Study group | Role | What they receive |
|---|---|---|
| Ritlecitinib higher dose | Experimental | Participants will receive
1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks. Receives: Drug: Ritlecitinib higher dose |
| Ritlecitinib lower dose | Experimental | Participants will receive
1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks. Receives: Drug: Ritlecitinib lower dose |
| Placebo | Placebo comparator | Participants will receive
1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20.
The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 24
For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10.
The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 24
Secondary outcomes (18)
For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved".
The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 24
For all countries: Change from baseline (CFB) in SALT score.
The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Response based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint).
The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18
For all countries: Response based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint).
The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18.
For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint).
The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18.
For all countries: Response based on improvement from baseline for each Alopecia Areata Patient Priority Outcomes (AAPPO) item.
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score.
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in PROMIS Parent Proxy Anxiety Symptoms T-score.
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)).
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score.
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score in participants with an abnormal EBA at baseline.
The difference in proportions of participants with the EBA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score in participants with an abnormal ELA at baseline.
The difference in proportions of participants with the ELA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Plasma concentration of ritlecitinib.
Measured: Post dose hour 1 and hour 3 at day 28 or day 56.
For all countries: Incidence of treatment emergent Adverse Events (AEs).
To evaluate safety and tolerability of ritlecitinib over time.
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 8 months).
For all countries: Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.
To evaluate safety and tolerability of ritlecitinib over time.
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 8 months).
CFB in AAPPO activity limitation score.
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
For all countries: Acceptability and palatability assessment.
To evaluate acceptability and palatability of the age-appropriate formulation.
Measured: Week 2 and Week 18
CFB in AAPPO emotional symptoms score.
The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.
Measured: Week 2, Week 4, Week 8, Week 12, Week 18, Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start31 Jul 2025
- Primary completion2 Dec 2026 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Alopecia AreataStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029711
- Sponsor's protocol ID
- B7981027
- Other IDs
- 2024-515438-33-00
- Acronym
- B7981027
- Status last verified
- Aug 2026
- First submitted
- 11 Jun 2025
- Last updated
- 26 Aug 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.
- Expanded access
- Available