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Alopecia AreataPhase 2/3ALLEGRO-2b/3NCT03732807

PF-06651600 for the Treatment of Alopecia Areata

A Phase 2/3 study testing PF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1 and PF-06651600 Maintenance Dose #2 in people with Alopecia Areata, run by Pfizer at 155 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Alopecia Areata
What is being tested?
PF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1 and PF-06651600 Maintenance Dose #2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
718 participants
Where
155 sitesin 18 countries
Study dates
3 Dec 2018to 24 Jun 2021
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of alopecia areata with no other cause of hair loss
  • ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss ≤10 years

Who cannot join

  • Other types of alopecia or other diseases that can cause hair loss
  • Other scalp diseases that could interfere with assessment of hair loss/regrowth
  • Subjects with shaved heads must not enter the study until hair has grown back \& is considered stable by the investigator
  • Any previous use of any Janus kinase (JAK) inhibitor

Trial locations and contacts

155 sites in 18 countries.

155 sites in 18 countries

United States46 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Colorado Hospital Clinical and Translational Research Center

    Aurora, Colorado, 80045

  • University of Colorado Hospital Outpatient Pavillion

    Aurora, Colorado, 80045

  • Mosaic Dermatology

    Beverly Hills, California, 90211

  • The University of Alabama at Birmingham Hospital Outreach Lab

    Birmingham, Alabama, 35233

  • The University of Alabama at Birmingham, Department of Dermatology

    Birmingham, Alabama, 35233

  • The University of Alabama at Birmingham, Department of Dermatology

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Siperstein Dermatology Group

    Boynton Beach, Florida, 33472

  • UNC CTRC

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals, Investigational Drug Service

    Chapel Hill, North Carolina, 27514

  • UNC Dermatology Clinical Trials Unit

    Chapel Hill, North Carolina, 27516

  • Medstar Georgetown University Hospital - Department of Dermatology

    Chevy Chase, Maryland, 20815

  • Northwestern Medical Group

    Chicago, Illinois, 60611

  • Northwestern Medicine Diagnostic Testing Center

    Chicago, Illinois, 60611

  • Northwestern Medicine

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital, Investigational Research Pharmacy

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS;

    Iowa City, Iowa, 52242

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center

    Irvine, California, 92697

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • University of Minnesota Department of Dermatology

    Minneapolis, Minnesota, 55455

  • University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke

    Minneapolis, Minnesota, 55455

  • Dermatology Specialists, Inc.

    Murrieta, California, 92562

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Church Street Research Unit

    New Haven, Connecticut, 06519

  • NYU School of Medicine, The Ronald O. Perelman Department of Dermatology

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Skin Specialists, PC

    Omaha, Nebraska, 68144

  • Park Avenue Dermatology

    Orange Park, Florida, 32073

  • University of California, San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente Clinical Trials Unit

    San Francisco, California, 94118

  • Southern California Dermatology, Inc.

    Santa Ana, California, 92701

  • NorthShore University HealthSystem

    Skokie, Illinois, 60077

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Vital Prospects Clinical Research Institute, P.C

    Tulsa, Oklahoma, 74136

  • The Dermatology Group, P.C.

    Verona, New Jersey, 07044

  • Medstar Georgetown University Hospital Center-Department of Otolaryngology

    Washington D.C., District of Columbia, 20007

  • Medstar Washington Hospital Center-Claude Nogay Research Pharmacy

    Washington D.C., District of Columbia, 20010

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Medstar Georgetown University Hospital Center-Department of Pediatrics

    Washington D.C., District of Columbia, 20016

Other trials in United States

Canada12 sites

  • Medicor Research Inc

    Greater Sudbury, Ontario, P3A1W8

  • Sudbury Skin Clinique

    Greater Sudbury, Ontario, P3C 1X8

  • Eastern Canada Cutaneous Research Associates Ltd.

    Halifax, Nova Scotia, B3H 1Z2

  • Guenther Research Inc

    London, Ontario, N6A 3H7

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

  • Innovaderm Research Inc.

    Montreal, Quebec, H2X 2V1

  • The Centre for Clinical Trials

    Oakville, Ontario, L6J 7W5

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique du Quebec metropolitain

    Québec, Quebec, G1V 4X7

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario, L4C 9M7

  • Research Toronto

    Toronto, Ontario, M4W 2N4

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

China11 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept

    Hangzhou, Zhejiang, 310009

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Huashan Hospital, Fudan University/Dermatology Department

    Shanghai, Shanghai Municipality, 200040

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

Other trials in China

Spain10 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Reina Sofía, Servicio Dermatologia

    Córdoba, 14004

  • Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Servicio Radiologia, Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario La Paz

    Madrid, 28046

  • Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe

    Valencia, 46026

  • Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe

    Valencia, 46026

  • Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe

    Valencia, 46026

Other trials in Spain

United Kingdom10 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, EAST Sussex, BN2 5BE

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 5BE

  • NHS Tayside Ninewells Hospital

    Dundee, DD1 9SY

  • NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • NHS Greater Glasgow and Clyde

    Glasgow, G51 4TF

  • Southampton University Hospital NHS Foundation Trust, University Hospital Southampton

    Hampshire, SO16 6YD

  • Harley Grove Medical Centre

    London, E3 2AT

  • Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital,

    London, SE1 7EH

  • Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital,

    London, SE1 9RT

  • Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital

    Southampton, Hampshire, SO14 0YG

Other trials in United Kingdom

Russia9 sites

  • State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary

    Chelyabinsk, 454092

  • University Clinic of Kirov SMU

    Kirov, 610035

  • Clinical Medical Center of A.I. Yevdokimov MSMSU

    Moscow, 111398

  • Federal State Autonomous Institution National Medical Research Centre of Childrens Health

    Moscow, 119991

  • State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"

    Rostov-on-Don, 344002

  • Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)

    Saint Petersburg, 191123

  • Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"

    Saint Petersburg, 191123

  • Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -

    Saint Petersburg, 194021

  • State Autonomous Healthcare Institution of the Yaroslavl Region Clinical Emergency Hospital

    Yaroslavl, 150003

Other trials in Russia

Australia8 sites

  • The Skin Centre

    Benowa, Queensland, 4217

  • Skin Health Institute

    Carlton, Victoria, 3053

  • Sinclair Dermatology

    East Melbourne, Victoria, 3002

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales, 2217

  • St George Dermatology and Skin Cancer Centre

    Kogarah, New South Wales, 2217

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Park Campus

    Parkville, Victoria, 3052

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

Poland8 sites

  • Centermed Krakow Sp.z o.o.

    Krakow, 31-530

  • Medicover Sp.z.o.o

    Lodz, 90-368

  • Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436

  • Sanova Audiological Care Polska Sp.z.o.o

    Lodz, 91-867

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • RCMed Oddzial Warszawa

    Warsaw, 02-657

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50-566

Other trials in Poland

Taiwan7 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch

    Kaohsiung City, 83301

  • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Chung-Shan Medical University Hospital

    Taichung, 40201

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital-Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Germany6 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Emovis GmbH

    Berlin, 10629

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • University Hospital Frankfurt

    Frankfurt am Main, 60590

  • University Hospital Schleswig-Holstein

    Lübeck, 23538

  • University Hospital Muenster

    Münster, 48149

Other trials in Germany

Japan6 sites

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Juntendo Tokyo Koto Geriatric Medical Center

    Koto-ku, Tokyo, 136-0075

  • Nagoya City University Hospital - Dermatology

    Nagoya, Aichi-ken, 467-8602

  • Osaka City University Hospital

    Osaka, 545-8586

  • Tohoku University hospital

    Sendai, Miyagi, 980-8574

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

Other trials in Japan

Czechia5 sites

  • DERMAMEDICA s.r.o.

    Náchod, 54701

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Clintrial s.r.o.

    Prague, 100 00

  • Sanatorium profesora Arenbergera

    Prague, 11000

  • Nemocnice Na Bulovce

    Praha 8- Liben, 180 81

Other trials in Czechia

Chile4 sites

  • Centro Internacional de Estudios Clinicos, CIEC

    Santiago, Recoleta, 8420383

  • Centro Medico Skin Med

    Santiago, Santiago Metropolitan, 7580206

  • Clinica Dermacross S.A.

    Santiago, Santiago Metropolitan, 7640881

  • Medical Skin Center

    Viña del Mar, Valparaiso, 2530900

Other trials in Chile

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1085

  • Debreceni Egyetem

    Debrecen, 4032

  • Bugat Pal Korhaz, Borgyogyaszat

    Gyöngyös, 3200

  • Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar

    Szeged, 6720

Other trials in Hungary

Colombia3 sites

  • Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS

    Bogotá, D.C., 110221

  • Fundacion Centro de Investigacion Clinica CIC

    Medellín, Antioquia, 050001

  • Fundacion Hospitalaria San Vicente de Paul

    Medellín, Antioquia, 050010

Other trials in Colombia

Argentina2 sites

  • CINME Centro de Investigaciones Metabolicas

    CABA, Buenos Aires, C1027AAP

  • Psoriahue Medicina Interdisciplinaria

    CABA, C1425DKG

Other trials in Argentina

Mexico2 sites

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, C.P. 91900

  • Hospital D'Maria

    Veracruz, CP. 91910

Other trials in Mexico

South Korea2 sites

  • Pusan National University Hospital

    Busan, 49241

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS

This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Conditions
Alopecia Areata
Being tested
PF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1, PF-06651600 Maintenance Dose #2, PF-06651600 Maintenance Dose #3, Placebo
Keywords
Alopecia, Alopecia totalis, Alopecia universalis, Patchy hair loss, Diffuse hair loss, Hair loss, Hair disease, PF-06651600, Ritlecitinib
Medical subject headings
Alopecia Areata, Alopecia, Alopecia universalis, Hair Diseases

What participants receive

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

  • PF-06651600 Induction DoseDrug

    Oral tablets taken once daily (QD)

  • PF-06651600 Maintenance Dose #1Drug

    Oral tablets taken QD

  • PF-06651600 Maintenance Dose #2Drug

    Oral tablets taken QD

  • PF-06651600 Maintenance Dose #3Drug

    Oral tablets taken QD

  • PlaceboDrug

    Oral tablets taken QD

Study groups in NCT03732807
Study groupRoleWhat they receive
Sequence AExperimentalInduction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
Receives: Drug: PF-06651600 Induction Dose; Drug: PF-06651600 Maintenance Dose #1
Sequence BExperimentalInduction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
Receives: Drug: PF-06651600 Induction Dose; Drug: PF-06651600 Maintenance Dose #2
Sequence CExperimentalMaintenance dose #1 given QD for 48 weeks
Receives: Drug: PF-06651600 Maintenance Dose #1
Sequence DExperimentalMaintenance dose #2 given QD for 48 weeks
Receives: Drug: PF-06651600 Maintenance Dose #2
Sequence EExperimentalMaintenance dose #3 given QD for 48 weeks
Receives: Drug: PF-06651600 Maintenance Dose #3
Sequence FExperimentalPlacebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
Receives: Drug: PF-06651600 Induction Dose; Drug: PF-06651600 Maintenance Dose #1; Drug: Placebo
Sequence GExperimentalPlacebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
Receives: Drug: PF-06651600 Maintenance Dose #1; Drug: Placebo

What is being measured

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

  1. Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported.

    Measured: Week 24

Secondary outcomes (16)

  1. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.

    Measured: Week 24

  2. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.

    Measured: Week 24

  3. Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24

    PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.

    Measured: Week 24

  4. Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model

    The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.

    Measured: Week 24

  5. Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model

    The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.

    Measured: Week 24

  6. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.

    Measured: Week 4, 8, 12, 18, 28, 34, 40, and 48

  7. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.

    Measured: Week 4, 8, 12, 18, 28, 34, 40, and 48

  8. Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.

    Measured: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

  9. Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.

    Measured: Baseline (Day 1), Week 4, 8, 12, 18, and 24

  10. Change From Baseline in SALT Score at Week 28, 34, 40, and 48

    SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.

    Measured: Baseline (Day 1), Week 28, 34, 40, and 48

  11. Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

    EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.

    Measured: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

  12. Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

    ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.

    Measured: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48

  13. Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48

    PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.

    Measured: Week 4, 8, 12, 18, 24, 34, 40, and 48

  14. Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations

    AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.

    Measured: Baseline (Day 1), Week 4, 8, 12, 18, and 24

  15. Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations

    AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.

    Measured: Baseline (Day 1), Week 34, 40, and 48

  16. Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48

    AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.

    Measured: Week 4, 8, 12, 18, 24, 34, 40, and 48

Timeline

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

  1. First posted7 Nov 2018
  2. Study start3 Dec 2018
  3. Primary completion31 Dec 2020
  4. Study completion24 Jun 2021

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
718 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732807
Sponsor's protocol ID
B7981015
Other IDs
2018-001714-14, ALLEGRO 2B/3, 2018
Acronym
ALLEGRO-2b/3
Status last verified
Feb 2022
First submitted
5 Nov 2018
Last updated
24 Feb 2022
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.

Publications

  • Blume-Peytavi U, Craiglow B, Netravali IA, Doche I, Harada K, Wajsbrot D, Bonfanti G, Ishowo-Adejumo R, Wolk R, Tran H. Patterns of Clinical Response in Rollover Adolescent Patients with Alopecia Areata Treated with Ritlecitinib in the Ongoing Long-Term, Open-Label, Phase 3 ALLEGRO-LT Study. Dermatol Ther (Heidelb). 2026 Oct 1. doi: 10.1007/s13555-026-01911-x. Online ahead of print.

    PubMed 42823604

  • Senna M, Hanna S, Ueki R, Zhang X, Aguh C, Piraccini BM, Wajsbrot D, Nagy E, Sadrarhami M, Chen S, Wolk R, Tran H, Lejeune A. Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2026 Jul 22. doi: 10.1007/s40257-026-01062-x. Online ahead of print.

    PubMed 42481842

  • Senna M, Soung J, Figueras I, King B, Kinoshita-Ise M, Hanna S, Wu W, Wajsbrot D, Woodworth D, Wolk R, Chaudhry A, Lejeune A, Tran H. Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies. Am J Clin Dermatol. 2026 Mar 31. doi: 10.1007/s40257-026-01029-y. Online ahead of print.

    PubMed 41917311

  • Mauer J, Whichello C, Hauber B, Krucien N, Law EH, Trapali M, Senna M, Zwillich SH, Wolk R, Tervonen T. A Patient Preference-Weighted Quantitative Benefit-Risk Analysis of Ritlecitinib for Alopecia Areata to Inform Medical Decision Making. Value Health. 2026 Feb;29(2):277-284. doi: 10.1016/j.jval.2025.09.007. Epub 2025 Sep 24.

    PubMed 41005700

  • Mostaghimi A, Gibson A, Dwyer G, Oluboyede Y, Mazar I, Gorbatenko-Roth K, Law E. Exploring Factors That Influence the Measurement of Patient-Reported Impacts of Alopecia Areata. Dermatol Ther (Heidelb). 2025 Jun;15(6):1391-1403. doi: 10.1007/s13555-025-01400-7. Epub 2025 Apr 22.

    PubMed 40261547

  • King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Ohyama M, Edwards RA, Bonfanti G, Kerkmann U, Wajsbrot D, Ishowo-Adejumo R, Zwillich SH, Lejeune A. Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1163-1173. doi: 10.1111/jdv.20547. Epub 2025 Feb 17.

    PubMed 39962358

  • Sinclair R, Mesinkovska N, Mitra D, Wajsbrot D, Law EH, Wolk R, King B. Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial. Am J Clin Dermatol. 2025 Jan;26(1):109-119. doi: 10.1007/s40257-024-00899-4. Epub 2024 Oct 23.

    PubMed 39441519

  • Mesinkovska N, King B, Zhang X, Guttman-Yassky E, Magnolo N, Sinclair R, Mizuashi M, Shapiro J, Peeva E, Banerjee A, Takiya L, Cox LA, Wajsbrot D, Kerkmann U, Law E, Wolk R, Schaefer G. Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis. J Dermatol. 2024 Nov;51(11):1414-1424. doi: 10.1111/1346-8138.17442. Epub 2024 Sep 27.

    PubMed 39328096

  • Fu J, Egeberg A, Holmes S, Vano-Galvan S, Steinhoff M, Edwards R, Bonfanti G, Nagra R, Wolk R, Tran H, Law E. Impact of Previous Alopecia Areata Treatment on Efficacy Responses up to Week 48 Following Ritlecitinib Treatment: A Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2759-2769. doi: 10.1007/s13555-024-01260-7. Epub 2024 Sep 10.

    PubMed 39254890

  • King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.

    PubMed 38263353

  • Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

    PubMed 37917289

  • Thaci D, Tziotzios C, Ito T, Ko J, Karadag AS, Fang H, Edwards RA, Bonfanti G, Wolk R, Tran H, Law E. Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study. Dermatol Ther (Heidelb). 2023 Nov;13(11):2621-2634. doi: 10.1007/s13555-023-00997-x. Epub 2023 Sep 14.

    PubMed 37707764

  • King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. A plain language summary on ritlecitinib treatment for adults and adolescents with alopecia areata. Immunotherapy. 2023 Oct;15(14):1093-1103. doi: 10.2217/imt-2023-0069. Epub 2023 Jul 5.

    PubMed 37403610

  • King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529. doi: 10.1016/S0140-6736(23)00222-2. Epub 2023 Apr 14.

    PubMed 37062298

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1 and PF-06651600 Maintenance Dose #2 in people with Alopecia Areata, run by Pfizer at 155 sites in 18 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 4 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: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Canada, China, Spain, United Kingdom and 13 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Yes. Results are posted in the registry (first posted 24 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 (time frame: Week 24). 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 NCT03732807, which also lists 14 linked publications.

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 24 Feb 2022.

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