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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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 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

Other trials in United States

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

Other trials in China

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

Other trials in Poland

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

Other trials in France

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

Other trials in Japan

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

Other trials in Czechia

Italy3 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

  • Asst Spedali Civili Di Brescia

    Brescia, 25123

  • Policlinico "G. Rodolico

    Catania, 95123

Other trials in Italy

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

Other trials in United Kingdom

Spain2 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

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.

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 groups in NCT07029711
Study groupRoleWhat they receive
Ritlecitinib higher doseExperimentalParticipants 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 doseExperimentalParticipants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.
Receives: Drug: Ritlecitinib lower dose
PlaceboPlacebo comparatorParticipants 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.

  1. 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

  2. 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)

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. For all countries: Plasma concentration of ritlecitinib.

    Measured: Post dose hour 1 and hour 3 at day 28 or day 56.

  14. 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).

  15. 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).

  16. 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.

  17. For all countries: Acceptability and palatability assessment.

    To evaluate acceptability and palatability of the age-appropriate formulation.

    Measured: Week 2 and Week 18

  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.

  1. First posted19 Jun 2025
  2. Study start31 Jul 2025
  3. Primary completion2 Dec 2026 (estimated)
  4. Study completion6 Jan 2027 (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
208 participants (actual)
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

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 83 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20. (time frame: Week 24). 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 NCT07029711.

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 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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