Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-LT)

A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

This is a global Phase 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 alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: PF-06651600; Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine; Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 1057
• Phase: 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 & 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
      • Royal Melbourne Hospital
• Canada
  • 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
    • Greater Sudbury, Ontario, Canada, P3C 1X8
      • Sudbury Skin Clinique
    • 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
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
• Chile
  • Viña del Mar, Chile, 2542577
    • Medical Skin Center
  • LAS Condes
    • Santiago, LAS Condes, Chile, 7580206
      • Centro Médico Skin Med
  • Recoleta
    • Santiago, Recoleta, Chile, 8420383
      • Centro Internacional de Estudios Clinicos - CIEC
  • Vitacura
    • Santiago, Vitacura, Chile, 7640881
      • Clinica Dermacross S.A.
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, 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 Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of College of Medicine, Zhejiang University
• Colombia
  • Bogota D.C., Colombia, 110221
    • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
  • Antioquia
    • Medellín, Antioquia, Colombia, 050001
      • Fundacion Centro de Investigacion Clinica CIC
    • Medellín, Antioquia, Colombia, 050010
      • Fundación Hospitalaria San Vicente de Paul
• Czechia
  • Náchod, Czechia, 547 01
    • DERMAMEDICA s.r.o.
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Prague, Czechia, 100 00
    • Clintrial s.r.o.
  • Prague, Czechia, 110 00
    • Sanatorium Profesora Arenbergera
• 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
  • Lübeck, Germany, 23538
    • University Hospital Schleswig-Holstein
  • Münster, Germany, 48149
    • University hospital Muenster
• Japan
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • 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
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Kyorin University Hospital
• Mexico
  • Veracruz, Mexico, 91900
    • Sociedad de Metabolismo y Corazón S.C.
  • Veracruz, Mexico, 91910
    • Hospital D Maria
• Poland
  • Grodzisk Mazowiecki, Poland, 05-825
    • McBk S.C.
  • Krakow, Poland, 31-530
    • Centermed Krakow Sp.z o.o.
  • Lodz, Poland, 90-436
    • Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Dermedic Jacek Zdybski
  • Warsaw, Poland, 02-793
    • ETG Warszawa
  • Warsaw, Poland, 02-962
    • Royalderm Agnieszka Nawrocka
  • Warsaw, Poland, 00-892
    • RCMed Oddzial Warszawa
  • Warsaw, Poland, 02-661
    • Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporów
  • Wroclaw, Poland, 50-566
    • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
  • Wroclaw, Poland, 50-220
    • EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-500
      • Twoja Przychodnia SCM
• Russia
  • Chelyabinsk, Russia, 454092
    • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"
  • Kirov, Russia, 610035
    • University Clinic of Kirov SMU
  • Moscow, Russia, 111398
    • FSBEI HE Russian University of Medicine of the MoH of Russia
  • Moscow, Russia, 119991
    • Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"
  • Rostov-on-Don, Russia, 344002
    • State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
  • Saint Petersburg, Russia, 191123
    • Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
  • Saint Petersburg, Russia, 191123
    • Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
  • Saint Petersburg, Russia, 194021
    • Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
  • Yaroslavl, Russia, 150003
    • State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz: Servicio de Farmacia
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
  • R.o.c.
    • Taichung, R.o.c., Taiwan, 40201
      • Chung-Shan Medical University Hospital
• United Kingdom
  • Brighton, United Kingdom, BN2 1ES
    • University Hospitals Sussex NHS Foundation Trust (UHSussex)
  • Glasgow, United Kingdom, G51 4TF
    • NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital
  • 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
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust
    • Southampton, Hampshire, United Kingdom, SO14 0YG
      • University Hospital Southampton NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham, Department of Dermatology
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham Hosptial Outreach Lab
  • California
    • Beverly Hills, California, United States, 90211
      • Mosaic Dermatology
    • Irvine, California, United States, 92697
      • Univ of California, Irvine, 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 Outpatient Pavilion
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital Clinical and Translational Research Center
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale School of Medicine, Yale Center for Clinical Investigations
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
    • Washington D.C., District of Columbia, United States, 20007
      • Medstar Georgetown University Hospital - Department of Otolaryngology
    • Washington D.C., District of Columbia, United States, 20007
      • Medstar Georgetown University Hospital-Dept of Otolaryngology
    • Washington D.C., District of Columbia, United States, 20016
      • Medstar Georgetown University Hospital - 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
      • Velocity Clinical Research - Boise
  • Illinois
    • 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 Drug Service Pharmacy
    • Oakbrook Terrace, Illinois, United States, 60181
      • Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem Dermatology Clinical Trials Unit
    • 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
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Medstar Georgetown University Hospital - Department of Dermatology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Clinical Research Unit (CRU)
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Lillehei Clinical Research Unit (LCRU)
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC (Schlessinger MD)
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Schweiger Dermatology, 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
    • New York, New York, United States, 10018
      • Pura Dermatology (in c/o TrialSpark, Inc)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC CTRC
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Dermatology and Skin Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • The University of Texas Health Science Center at Houston
  • Virginia
    • Vienna, Virginia, United States, 22182
      • Tamjidi Skin Institute (in c/o TrialSpark, Inc)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

• Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
• De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
• De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
• No evidence of terminal scalp hair regrowth within 6 months (de novo only)
• Current episode of terminal scalp hair loss <=10 years (de novo only)

Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

• Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
• History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
• History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
• Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Exclusion criteria for all participants:

- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1; Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.	Drug: PF-06651600; 50 mg oral tablets/capsules; Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine; Single intramuscular injection administered to patients participating in the vaccine sub-study; Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine; Single intramuscular injection administered to patients participating in the vaccine sub-study
Experimental: Treatment sequence 2; Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.	Drug: PF-06651600; 50 mg oral tablets/capsules; Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine; Single intramuscular injection administered to patients participating in the vaccine sub-study; Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine; Single intramuscular injection administered to patients participating in the vaccine sub-study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)
Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit	Vital signs including blood pressure included systolic blood pressure (SBP) [Millimeters of mercury, mmHg]) and diastolic blood pressure (DBP) and pulse rate [beats per minute (bpm)] were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Criteria for vital sign abnormalities included: SBP<90mmHg, DBP<50 mmHg and pulse rate<40mmHg.	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)
Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit	Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (<0.8*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration <0.8*LLN or >1.5*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (>1.2*ULN), Prothrombin Time(>1.1*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (>3.0*ULN); Albumin, Urate (<0.8*LLN and >1.2*ULN; Urea Nitrogen,Creatinine Cholesterol >1.3*ULN; Cholesterol <0.8*LLN or >1.2*LLN, Triglycerides,Potassium,Calcium < 0.9x LLN & > 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite >=1; Leukocyte Erythrocytes, Leukocytes >=20; Epithelial Cells>=6, Hyaline Cast>1; Bacteria>20. Number of participants with any laboratory abnormality meeting specified criteria is included.	From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)
Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response	Booster response to tetanus toxoid was defined as: >=4-fold rise in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration at Month 1 if the pre-vaccination concentration was <=2.7 International Units per milliliter (IU/mL); OR >=2-fold rise in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination concentration was >2.7 IU/mL. Two-sided 95% confidence interval (CI) was based on Clopper-Pearson exact method.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of Study	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.	From start of study intervention (Day 1) until end of study
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until End of Study	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.	From start of study intervention (Day 1) until end of study
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Until End of Study	Vital signs including blood pressure (systolic and diastolic blood pressure [Millimeters of mercury, mmHg]) and pulse rate (beats per minute [bpm]) were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Clinically significant abnormalities will be determined by investigator.	From start of study intervention (Day 1) until end of study
Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study	Following laboratory parameters were assessed: Hemoglobin, Hematocrit, Erythrocytes Erythrocyte (ery.) corpuscular volume, Ery. Mean Corpuscular hemoglobin concentration, Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils, Monocytes, Prothrombin Time, Bilirubin, Direct Bilirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase; Albumin, Urate; Urea Nitrogen, Creatinine, Cholesterol, Triglycerides, Potassium, Calcium, Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite, Leukocyte Erythrocytes, Leukocytes; Epithelial Cells, Hyaline Cast, Bacteria. Clinically significant abnormalities will be determined by investigator.	From start of study intervention (Day 1) until end of study
Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score <= 10 were reported. 95% CI was calculated based on normal approximation.	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Percentage of Participants Achieving Response Based on Alopecia Areata (AA) SALT Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Percentage of Participants Achieving Response Based on SALT Overall Score <= 20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score <=20 were reported. 95% CI was calculated based on normal approximation.	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Percentage of Participants Achieving Response Based on AA SALT Score <=20 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), with lower score indicating less hair loss. 95% CI was calculated based on normal approximation.	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Change From Baseline in SALT Overall Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing division of scalp hair into four quadrants (back, top of scalp, right side and left side), with each of four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score is sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.	Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Change From Baseline in AA SALT Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into 4 quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss). SALT AA Score = SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), lower score= less hair loss. Baseline (Roll-over participants: Day 1 from Study B7931005 or B7981015; De novo participants: Day 1 from Study B7981032).	Baseline, At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in Overall SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). An Overall SALT 75 response was a 75% or greater reduction from baseline in SALT score.	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Percentage of Participants Achieving Atleast 75% Improvement in AA SALT Score From Baseline at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36	SALT=quantitative assessment of AA severity based on scalp terminal hair loss. Scalp hair was divided into four quadrants (back, top of scalp, right side and left side), with each given an accurate determination of percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of scalp in that area. SALT score=sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. SALT AA Score= SALT overall score minus SALT AGA score, where SALT overall score included any hair loss regardless of etiology and SALT AGA score included scalp hair loss only due to androgenetic alopecia. SALT AA score ranged from 0 (no hair loss) to 100 (complete scalp hair loss), where lower score=less hair loss. SALT 75 response= 75% or greater reduction from baseline in AA SALT score.	At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyebrow Assessment (EBA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal EBA Score at Baseline	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. Higher scores represent lesser loss of eyebrow hair. 95% CI was based on normal approximation.	At Months 1, 3, 6, 12, 18, 24 and 36
Main Study: Percentage of Participants Achieving Atleast 2-Grade Improvement From Baseline or Absolute Score of 3 in the Eyelash Assessment (ELA) at Months 1, 3, 6, 12, 18, 24 and 36 in Participants Without Normal ELA Score at Baseline	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. Higher scores represent lesser loss of eyelash hair.	At Months 1, 3, 6, 12, 18, 24 and 36
Main Study: Percentage of Participants Achieving Patient's Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Months 1, 3, 6, 9, 12, 18, 24 and 36	PGI-C is a self-administered single item questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. Participants were required to select their response on a 7-point scale ranging from 1 (greatly worsened), 2=moderately worsened, 3=slightly worsened, 4=not changed, 5= slightly improved, 6=moderately improved, 7 (greatly improved). 95% CI was based on normal approximation.	At Months 1, 3, 6, 9, 12, 18, 24 and 36
Main Study: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36: Emotional Symptoms and Activity Limitations	AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 5-8 assessed emotional symptoms with responses scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations with responses scored from 0='not at all' to 4='completely'. AAPPO emotional symptoms sub score was calculated as mean of items 5-8 and ranged from 0 (never) to 4 (always), where higher scores indicated more emotional symptoms. 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. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36
Main Study: Percentage of Participants With Response Based on Hair Loss Improvement From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Months 1, 3, 6, 9, 12, 18, 24 and 36, Among Participants With Score >=2 at Baseline	AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss from the scalp, eyebrows, eyelashes and body using a 5 point scale that ranged from 0 ='no hair loss' and 4='complete hair loss'. In this outcome measure, percentage of participants with AAPPO domain scores of 0 = no hair loss or 1 = a little hair loss, among participants with score >=2 at baseline are reported.	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36
Main Study: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36
Main Study: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. For roll-over participants originating from Study B7931005 or B7981015, baseline is day 1 from Study B7931005 or B7981015. For de novo participants, baseline is day 1 from Study B7981032.	Baseline, At Months 1, 3, 6, 9, 12, 18, 24 and 36
Main Study: Percentage of Participants With Improvement on HADS Depression Score at Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The depression subscale comprised of 7 items with score ranging from 0 (no presence of depression) to 3 (severe feeling of depression). Total depression subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of depression symptoms. Improvement on HADS depression score was considered as achieving a "normal" depression subscale score indicative of an absence of depression. Among adults, a HADS-D score of 0-7 was considered "normal"; for adolescents, a HADS-D score of 0-6 was considered "normal". 95% CI was calculated based on normal approximation.	At Months 1, 3, 6, 9, 12, 18, 24 and 36
Main Study: Percentage of Participants With Improvement on HADS Anxiety Score At Months 1, 3, 6, 9, 12, 18, 24 and 36	HADS is a validated 14-item questionnaire used to assess states of anxiety and depression over the past week. The HADS consisted of 2 subscales, one for anxiety (HADS-A) and one for depression (HADS-D). The anxiety subscale comprised of 7 items with score ranging from 0 (no anxiety) to 3 (severe anxiety). Total anxiety subscale score was calculated as the sum of 7 items and ranged from 0 to 21; higher score indicating greater severity of anxiety symptoms. Improvement on HADS anxiety score was considered as achieving a "normal" anxiety subscale score indicative of an absence of anxiety. Among adults, a HADS-A score of 0-7 was considered "normal"; for adolescents, a HADS-A score of 0-8 was considered "normal". 95% CI was calculated based on normal approximation.	At Months 1, 3, 6, 9, 12, 18, 24 and 36
Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=1.0 International Units Per Milliliter (IU/mL) at Month 1-Tdap Vaccination	Percentage of participants with anti-tetanus antibody level >=1.0 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.	Month 1
Vaccine Sub-study: Percentage of Participants With Anti-tetanus Antibody Level >=0.1 IU/mL at Month 1-Tdap Vaccination	Percentage of participants with anti-tetanus antibody level >=0.1 IU/mL at Month 1 were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.	Month 1
Vaccine Sub-study: Percentage of Participants With >=4 Times Increase in Anti-tetanus Antibody Level From Baseline at Month 1-Tdap Vaccination	Percentage of participants with >=4 times increase in anti-tetanus antibody level from baseline were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.	Month 1
Vaccine Sub-study: Geometric Mean Fold Change in Anti-tetanus Levels Above Baseline Values at Month 1-Tdap Vaccination	Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Fold change was defined as the ratio of the post-baseline result to the baseline result. The assay results below the LLOQ were set to 0.5 * LLOQ except when pre-vaccination assay results is < LLOQ while postvaccination result is >= LLOQ, in which case the pre-vaccination value will be set to LLOQ.	From Baseline (pre-vaccination on Day 1) to Month 1
Vaccine Sub-study: Geometric Mean Concentrations (GMCs) of Anti-tetanus Antibody Levels at Month 1-Tdap Vaccination	Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5* LLOQ.	Month 1
Vaccine Sub-study: Percentage of Participants With Human Serum Bactericidal Activity (hSBA) Titer >=1:8 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination	Percentage of participants with hSBA titer >=1.8 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.	Month 1
Vaccine Sub-study: Percentage of Participants With hSBA Titer >=1:4 at Month 1 Post-vaccination for Serogroup C-Meningococcal ACWY Vaccination	Percentage of participants with hSBA titer >=1.4 at 1 month post vaccination for serogroup C were reported in this outcome measure. Two-sided 95% CI was based on Clopper-Pearson exact method.	Month 1
Vaccine Sub-study: Geometric Mean Titers (GMT) of Antibodies for Serogroup C at Baseline and Month 1-Meningococcal ACWY Vaccination	Geometric mean and 95% CI were calculated by exponentiating the mean logarithm of the observed data and the corresponding CIs. Assay results below the LLOQ were set to 0.5* LLOQ.	Baseline (pre-vaccination on Day 1) and Month 1
Vaccine Sub-study: Number of Participants With SAEs	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events.	From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)
Vaccine Sub-study: Number of Participants With AEs	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)
Vaccine Sub-study: Number of Participants With AEs Leading to Discontinuation	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.	From day of vaccination (Day 1) up to 35 days post last dose of vaccine (up to Day 36)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Ueki R, Mizuashi M, Harada K, Zhang X, Wu W, Chung WH, Kwon O, Luo X, Basey V, Wolk R, Shi N, Fujita K, Shen Y, Hirose T. Efficacy and Safety of Ritlecitinib in the Asian Subpopulation of the ALLEGRO-2b/3 and ALLEGRO-LT Clinical Studies for Alopecia Areata. J Dermatol. 2026 Feb 6. doi: 10.1111/1346-8138.70154. Online ahead of print.
• 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.
• Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini BM, Luo X, Wolk R, Woodworth D, Schaefer G, Lejeune A. Efficacy and safety of the oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor ritlecitinib over 24 months: integrated analysis of the ALLEGRO phase IIb/III and long-term phase III clinical studies in alopecia areata. Br J Dermatol. 2025 Jan 24;192(2):215-227. doi: 10.1093/bjd/ljae365.
• 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.
• 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.
• Ishowo-Adejumo R, Zareba A, Wajsbrot D, Wolk R. Responses to Tetanus and Meningococcal Vaccines in Patients with Alopecia Areata Treated with Ritlecitinib. Dermatol Ther (Heidelb). 2026 Feb;16(2):1411-1417. doi: 10.1007/s13555-025-01648-z. Epub 2026 Jan 24.
• Tziotzios C, Sinclair R, Lesiak A, Mehlis S, Kinoshita-Ise M, Tsianakas A, Luo X, Law EH, Ishowo-Adejumo R, Wolk R, Sadrarhami M, Lejeune A. Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1152-1162. doi: 10.1111/jdv.20526. Epub 2025 Jan 23.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Alopecia; JAK inhibitor; Alopecia Areata; Alopecia universalis; Alopecia totalis; Hair loss; PF-06651600; Ritlecitinib
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia Areata; Alopecia; Alopecia universalis; Biological Products; Complex Mixtures; Toxoids; Vaccines; Tetanus Toxoid; PF-06651600
• Other Study ID Numbers: B7981032; 2023-509801-59-00 (Registry Identifier: CTIS (EU))

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