PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: PF-06651600 Induction Dose; Drug: PF-06651600 Maintenance Dose #1; Drug: PF-06651600 Maintenance Dose #2; Drug: PF-06651600 Maintenance Dose #3; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 718
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1425DKG
    • Psoriahue Medicina Interdisciplinaria
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1027AAP
      • CINME Centro de Investigaciones Metabolicas
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialists Pty Ltd
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology and Skin Cancer Centre
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research Pty Ltd
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3052
      • Royal Park Campus
• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Recherche Dermatologique Du Quebec Metropolitain
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z2
      • Eastern Canada Cutaneous Research Associates Ltd.
  • Ontario
    • London, Ontario, Canada, N6A 3H7
      • Guenther Research Inc
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc.
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre For Dermatology
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre
    • Sudbury, Ontario, Canada, P3A1W8
      • Medicor Research Inc
    • Sudbury, Ontario, Canada, P3C 1X8
      • Sudbury Skin Clinique
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• Chile
  • Recoleta
    • Santiago, Recoleta, Chile, 8420383
      • Centro Internacional de Estudios Clinicos, CIEC
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile, 7580206
      • Centro Medico Skin Med
    • Santiago, Región Metropolitana, Chile, 7640881
      • Clinica Dermacross S.A.
  • Valparaiso
    • Vina del Mar, Valparaiso, Chile, 2530900
      • Medical Skin Center
• China
  • Shanghai, China, 200025
    • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong - Shenzhen Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital, Fudan University/Dermatology Department
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of College of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050001
      • Fundacion Centro de Investigacion Clinica CIC
    • Medellin, Antioquia, Colombia, 050010
      • Fundacion Hospitalaria San Vicente de Paul
  • D.c.
    • Bogota, D.c., Colombia, 110221
      • Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
• Czechia
  • Nachod, Czechia, 54701
    • Dermamedica S.R.O.
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Praha 1, Czechia, 11000
    • Sanatorium profesora Arenbergera
  • Praha 10, Czechia, 100 00
    • Clintrial s.r.o.
  • Praha 8- Liben, Czechia, 180 81
    • Nemocnice Na Bulovce
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10629
    • emovis GmbH
  • Erlangen, Germany, 91054
    • Universitaetsklinikum Erlangen
  • Frankfurt am Main, Germany, 60590
    • University Hospital Frankfurt
  • Luebeck, Germany, 23538
    • University Hospital Schleswig-Holstein
  • Muenster, Germany, 48149
    • University Hospital Muenster
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Gyongyos, Hungary, 3200
    • Bugat Pal Korhaz, Borgyogyaszat
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
• Japan
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Nagoya City University Hospital - Dermatology
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Koto-ku, Tokyo, Japan, 136-0075
      • Juntendo Tokyo Koto Geriatric Medical Center
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
• Mexico
  • Veracruz, Mexico, C.P. 91900
    • Sociedad de Metabolismo y Corazon S.C.
  • Veracruz, Mexico, CP. 91910
    • Hospital D'Maria
• Poland
  • Krakow, Poland, 31-530
    • Centermed Krakow Sp.z o.o.
  • Lodz, Poland, 90-368
    • Medicover Sp.z.o.o
  • Lodz, Poland, 90-436
    • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
  • Lodz, Poland, 91-867
    • Sanova Audiological Care Polska Sp.z.o.o
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 02-962
    • Royalderm Agnieszka Nawrocka
  • Warszawa, Poland, 02-657
    • RCMed Oddzial Warszawa
  • Wroclaw, Poland, 50-566
    • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
• Russian Federation
  • Chelyabinsk, Russian Federation, 454092
    • State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
  • Kirov, Russian Federation, 610035
    • University Clinic of Kirov SMU
  • Moscow, Russian Federation, 111398
    • Clinical Medical Center of A.I. Yevdokimov MSMSU
  • Moscow, Russian Federation, 119991
    • Federal State Autonomous Institution National Medical Research Centre of Childrens Health
  • Rostov-on-Don, Russian Federation, 344002
    • State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
  • Saint Petersburg, Russian Federation, 191123
    • Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
  • Saint Petersburg, Russian Federation, 194021
    • Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
  • Saint Petersburg,, Russian Federation, 191123
    • Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
  • Yaroslavl, Russian Federation, 150003
    • State Autonomous Healthcare Institution of the Yaroslavl Region Clinical Emergency Hospital
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofía, Servicio Dermatologia
  • Cordoba, Spain, 14004
    • Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia
  • Cordoba, Spain, 14004
    • Servicio Radiologia, Hospital Universitario Reina Sofia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Valencia, Spain, 46026
    • Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe
  • Valencia, Spain, 46026
    • Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe
  • Valencia, Spain, 46026
    • Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Memorial Hospital Kaohsiung Branch
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taichung, Taiwan, 40201
    • Chung-Shan Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital-Linkou Branch
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Brighton and Sussex University Hospitals NHS Trust
  • Dundee, United Kingdom, DD1 9SY
    • NHS Tayside Ninewells Hospital
  • Glasgow, United Kingdom, G51 4TF
    • NHS Greater Glasgow and Clyde
  • Glasgow, United Kingdom, G51 4TF
    • NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
  • Hampshire, United Kingdom, SO16 6YD
    • Southampton University Hospital NHS Foundation Trust, University Hospital Southampton
  • London, United Kingdom, E3 2AT
    • Harley Grove Medical Centre
  • London,, United Kingdom, SE1 7EH
    • Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital,
  • London,, United Kingdom, SE1 9RT
    • Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital,
  • EAST Sussex
    • Brighton, EAST Sussex, United Kingdom, BN2 5BE
      • Brighton and Sussex University Hospitals NHS Trust
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO14 0YG
      • Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham Hospital Outreach Lab
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham, Department of Dermatology
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham, Department of Dermatology
  • California
    • Beverly Hills, California, United States, 90211
      • Mosaic Dermatology
    • Irvine, California, United States, 92697
      • University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center
    • Murrieta, California, United States, 92562
      • Dermatology Specialists, Inc.
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Clinical Trials Unit
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital Clinical and Translational Research Center
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital Outpatient Pavillion
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
    • New Haven, Connecticut, United States, 06519
      • Church Street Research Unit
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
    • Washington, District of Columbia, United States, 20007
      • Medstar Georgetown University Hospital Center-Department of Otolaryngology
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
    • Washington, District of Columbia, United States, 20016
      • Medstar Georgetown University Hospital Center-Department of Pediatrics
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Siperstein Dermatology Group
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine Diagnostic Testing Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital, Investigational Research Pharmacy
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS;
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Medstar Georgetown University Hospital - Department of Dermatology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Department of Dermatology
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, P.C.
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Dermatology Clinical Trials Unit
    • Chapel Hill, North Carolina, United States, 27514
      • UNC CTRC
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals, Investigational Drug Service
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks	Drug: PF-06651600 Induction Dose; Oral tablets taken once daily (QD); Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD
Experimental: Sequence B; Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks	Drug: PF-06651600 Induction Dose; Oral tablets taken once daily (QD); Drug: PF-06651600 Maintenance Dose #2; Oral tablets taken QD
Experimental: Sequence C; Maintenance dose #1 given QD for 48 weeks	Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD
Experimental: Sequence D; Maintenance dose #2 given QD for 48 weeks	Drug: PF-06651600 Maintenance Dose #2; Oral tablets taken QD
Experimental: Sequence E; Maintenance dose #3 given QD for 48 weeks	Drug: PF-06651600 Maintenance Dose #3; Oral tablets taken QD
Experimental: Sequence F; Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks	Drug: PF-06651600 Induction Dose; Oral tablets taken once daily (QD); Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD; Drug: Placebo; Oral tablets taken QD
Experimental: Sequence G; Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks	Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD; Drug: Placebo; Oral tablets taken QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24
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.	Week 24
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.	Week 24
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.	Week 24
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.	Week 24
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.	Week 4, 8, 12, 18, 28, 34, 40, and 48
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.	Week 4, 8, 12, 18, 28, 34, 40, and 48
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.	Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
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.	Baseline (Day 1), Week 4, 8, 12, 18, and 24
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.	Baseline (Day 1), Week 28, 34, 40, and 48
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.	Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
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.	Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
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.	Week 4, 8, 12, 18, 24, 34, 40, and 48
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.	Baseline (Day 1), Week 4, 8, 12, 18, and 24
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.	Baseline (Day 1), Week 34, 40, and 48
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.	Week 4, 8, 12, 18, 24, 34, 40, and 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24	HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.	Baseline (Day 1), Week 4, 8, 12, and 24
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48	HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.	Baseline (Day 1), Week 48
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24	HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.	Baseline (Day 1), Week 4, 8, 12, and 24
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48	HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.	Baseline (Day 1), Week 48
Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48	HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms.	Week 4, 8, 12, 24 and 48
Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48	HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms.	Week 4, 8, 12, 24 and 48

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Alopecia; Alopecia universalis; Alopecia totalis; Hair loss; PF-06651600; Ritlecitinib; Hair disease; Patchy hair loss; Diffuse hair loss
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: B7981015; 2018-001714-14 (EudraCT Number); ALLEGRO 2B/3 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No