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
2 other identifiers
interventional
1,057
17 countries
144
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
Longer than P75 for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2024
CompletedResults Posted
Study results publicly available
August 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2026
CompletedApril 9, 2026
March 1, 2026
4.9 years
July 1, 2019
June 24, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (32)
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of 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
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
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
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
At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36
- +27 more secondary outcomes
Study Arms (2)
Treatment sequence 1
EXPERIMENTALParticipants 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.
Treatment sequence 2
EXPERIMENTALParticipants 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.
Interventions
Single intramuscular injection administered to patients participating in the vaccine sub-study
Single intramuscular injection administered to patients participating in the vaccine sub-study
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (144)
The University of Alabama at Birmingham Hosptial Outreach Lab
Birmingham, Alabama, 35233, United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
The University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, 35294, United States
Mosaic Dermatology
Beverly Hills, California, 90211, United States
Univ of California, Irvine, Dermatology Clinical Research Center
Irvine, California, 92697, United States
Dermatology Specialists Inc.
Murrieta, California, 92562, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente Clinical Trials Unit
San Francisco, California, 94118, United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
University of Colorado Hospital Clinical and Translational Research Center
Aurora, Colorado, 80045, United States
University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado, 80045, United States
Yale School of Medicine, Yale Center for Clinical Investigations
New Haven, Connecticut, 06519, United States
Medstar Georgetown University Hospital - Department of Otolaryngology
Washington D.C., District of Columbia, 20007, United States
Medstar Georgetown University Hospital-Dept of Otolaryngology
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Medstar Georgetown University Hospital - Department of Pediatrics
Washington D.C., District of Columbia, 20016, United States
Siperstein Dermatology Group
Boynton Beach, Florida, 33472, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Medicine Diagnostic Testing Center
Chicago, Illinois, 60611, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital Investigational Drug Service Pharmacy
Chicago, Illinois, 60611, United States
Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
Oakbrook Terrace, Illinois, 60181, United States
NorthShore University HealthSystem Dermatology Clinical Trials Unit
Skokie, Illinois, 60077, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Medstar Georgetown University Hospital - Department of Dermatology
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114, United States
University of Minnesota Clinical Research Unit (CRU)
Minneapolis, Minnesota, 55455, United States
University of Minnesota Lillehei Clinical Research Unit (LCRU)
Minneapolis, Minnesota, 55455, United States
University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
Minneapolis, Minnesota, 55455, United States
Skin Specialists, PC (Schlessinger MD)
Omaha, Nebraska, 68144, United States
Schweiger Dermatology, P.C.
Verona, New Jersey, 07044, United States
NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
New York, New York, 10016, United States
Pura Dermatology (in c/o TrialSpark, Inc)
New York, New York, 10018, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
UNC CTRC
Chapel Hill, North Carolina, 27514, United States
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136, United States
Oregon Medical Research Center
Portland, Oregon, 97201, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401, United States
Tamjidi Skin Institute (in c/o TrialSpark, Inc)
Vienna, Virginia, 22182, United States
CINME Centro de Investigaciones Metabolicas
CABA, Buenos Aires, C1027AAP, Argentina
Psoriahue Medicina Interdisciplinaria
CABA, C1425DKG, Argentina
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217, Australia
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Skin Health Institute
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z2, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8, Canada
Guenther Research Inc
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X3, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, L4C 9M7, Canada
Research Toronto
Toronto, Ontario, M4W 2N4, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, Quebec, G1V 4X7, Canada
Centro Medico Skin Med
Santiago, LAS Condes, 7580206, Chile
Centro Internacional de Estudios Clinicos - CIEC
Santiago, Recoleta, 8420383, Chile
Clinica Dermacross S.A.
Santiago, Vitacura, 7640881, Chile
Medical Skin Center
Viña del Mar, 2542577, Chile
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Fundacion Centro de Investigacion Clinica CIC
Medellín, Antioquia, 050001, Colombia
Fundacion Hospitalaria San Vicente de Paul
Medellín, Antioquia, 050010, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
Bogota D.C., 110221, Colombia
DERMAMEDICA s.r.o.
Náchod, 547 01, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Clintrial s.r.o.
Prague, 100 00, Czechia
Sanatorium profesora Arenbergera
Prague, 110 00, Czechia
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Emovis GmbH
Berlin, 10629, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
University Hospital Frankfurt
Frankfurt am Main, 60590, Germany
University Hospital Schleswig-Holstein
Lübeck, 23538, Germany
University Hospital Muenster
Münster, 48149, Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, 136-0075, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Sociedad de Metabolismo y Corazon S.C.
Veracruz, 91900, Mexico
Hospital D Maria
Veracruz, 91910, Mexico
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, 71-500, Poland
McBk S.C.
Grodzisk Mazowiecki, 05-825, Poland
Centermed Krakow Sp.z o.o.
Krakow, 31-530, Poland
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
RCMed Oddzial Warszawa
Warsaw, 00-892, Poland
Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
Warsaw, 02-661, Poland
ETG Warszawa
Warsaw, 02-793, Poland
Royalderm Agnieszka Nawrocka
Warsaw, 02-962, Poland
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
Wroclaw, 50-220, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, 50-566, Poland
Centrum Medyczne OPOROW
Wroclaw, 52-416, Poland
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"
Chelyabinsk, 454092, Russia
University Clinic of Kirov SMU
Kirov, 610035, Russia
FSBEI HE Russian University of Medicine of the MoH of Russia
Moscow, 111398, Russia
Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"
Moscow, 119991, Russia
State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
Rostov-on-Don, 344002, Russia
Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
Saint Petersburg, 191123, Russia
Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
Saint Petersburg, 191123, Russia
Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
Saint Petersburg, 194021, Russia
State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital
Yaroslavl, 150003, Russia
Pusan National University Hospital
Busan, 49241, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario La Paz: Servicio de Farmacia
Madrid, 28046, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Chung-Shan Medical University Hospital
Taichung, R.o.c., 40201, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO14 0YG, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
University Hospitals Sussex NHS Foundation Trust (UHSussex)
Brighton, BN2 1ES, United Kingdom
NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital
London, SE1 7EH, United Kingdom
Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital
London, SE1 7EH, United Kingdom
Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (7)
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.
PMID: 41917311DERIVEDUeki 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.
PMID: 41645877DERIVEDIshowo-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.
PMID: 41579233DERIVEDKing 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.
PMID: 39962358DERIVEDTziotzios 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.
PMID: 39846397DERIVEDPiliang 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.
PMID: 39432738DERIVEDKing 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.
PMID: 38263353DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer Clinical Trials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
July 18, 2019
Primary Completion
June 25, 2024
Study Completion
February 26, 2026
Last Updated
April 9, 2026
Results First Posted
August 14, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.