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
3 other identifiers
interventional
718
18 countries
155
Brief Summary
This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
155 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
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedStudy Start
First participant enrolled
December 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2021
CompletedResults Posted
Study results publicly available
February 24, 2022
CompletedFebruary 24, 2022
February 1, 2022
2.1 years
November 5, 2018
December 16, 2021
February 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (\<=) 20 at week 24 were reported.
Week 24
Secondary Outcomes (16)
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
Week 24
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
Week 24
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
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
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
Week 24
- +11 more secondary outcomes
Other Outcomes (6)
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
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
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
Baseline (Day 1), Week 4, 8, 12, and 24
- +3 more other outcomes
Study Arms (7)
Sequence A
EXPERIMENTALInduction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
Sequence B
EXPERIMENTALInduction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
Sequence C
EXPERIMENTALMaintenance dose #1 given QD for 48 weeks
Sequence D
EXPERIMENTALMaintenance dose #2 given QD for 48 weeks
Sequence E
EXPERIMENTALMaintenance dose #3 given QD for 48 weeks
Sequence F
EXPERIMENTALPlacebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
Sequence G
EXPERIMENTALPlacebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (155)
The University of Alabama at Birmingham Hospital Outreach Lab
Birmingham, Alabama, 35233, United States
The University of Alabama at Birmingham, Department of Dermatology
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
University of California, Irvine, Department of Dermatology, 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 Pavillion
Aurora, Colorado, 80045, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Church Street Research Unit
New Haven, Connecticut, 06519, United States
Medstar Georgetown University Hospital Center-Department of Otolaryngology
Washington D.C., District of Columbia, 20007, United States
Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
Washington D.C., District of Columbia, 20010, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Medstar Georgetown University Hospital Center-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
Advanced Clinical Research
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 Research Pharmacy
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
NorthShore University HealthSystem
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; Department of Pharmacy-IDS;
Iowa City, Iowa, 52242, 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
Boston, Massachusetts, 02114, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455, United States
University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
Minneapolis, Minnesota, 55455, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
The Dermatology Group, 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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
UNC CTRC
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals, Investigational Drug Service
Chapel Hill, North Carolina, 27514, United States
UNC Dermatology Clinical Trials Unit
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, 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 and 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
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Royal Park Campus
Parkville, Victoria, 3052, Australia
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z2, Canada
Medicor Research Inc
Greater Sudbury, Ontario, P3A1W8, 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
Québec, Quebec, G1V 4X7, Canada
Centro Internacional de Estudios Clinicos, CIEC
Santiago, Recoleta, 8420383, Chile
Medical Skin Center
Viña del Mar, RegiĂ³n de ValparaĂso, 2530900, Chile
Centro Medico Skin Med
Santiago, Santiago Metropolitan, 7580206, Chile
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881, Chile
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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
Huashan Hospital, Fudan University/Dermatology Department
Shanghai, Shanghai Municipality, 200040, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept
Hangzhou, Zhejiang, 310009, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Fundacion Centro de Investigacion Clinica CIC
MedellĂn, Antioquia, 050001, Colombia
Fundacion Hospitalaria San Vicente de Paul
MedellĂn, Antioquia, 050010, Colombia
Centro de InvestigaciĂ³n en ReumatologĂa y Especialidades MĂ©dicas SAS - CIREEM SAS
BogotĂ¡, D.C., 110221, Colombia
DERMAMEDICA s.r.o.
NĂ¡chod, 54701, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Clintrial s.r.o.
Prague, 100 00, Czechia
Sanatorium profesora Arenbergera
Prague, 11000, Czechia
Nemocnice Na Bulovce
Praha 8- Liben, 180 81, 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
LĂ¼beck, 23538, Germany
University Hospital Muenster
MĂ¼nster, 48149, Germany
Semmelweis Egyetem
Budapest, 1085, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Bugat Pal Korhaz, Borgyogyaszat
Gyöngyös, 3200, Hungary
Szegedi TudomĂ¡nyegyetem Altalanos Orvostudomanyi Kar
Szeged, 6720, Hungary
Nagoya City University Hospital - Dermatology
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
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Sociedad de Metabolismo y Corazon S.C.
Veracruz, C.P. 91900, Mexico
Hospital D'Maria
Veracruz, CP. 91910, Mexico
Centermed Krakow Sp.z o.o.
Krakow, 31-530, Poland
Medicover Sp.z.o.o
Lodz, 90-368, Poland
Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, 90-436, Poland
Sanova Audiological Care Polska Sp.z.o.o
Lodz, 91-867, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
RCMed Oddzial Warszawa
Warsaw, 02-657, Poland
Royalderm Agnieszka Nawrocka
Warsaw, 02-962, Poland
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak SpĂ³Å‚ka Partnerska
Wroclaw, 50-566, Poland
State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
Chelyabinsk, 454092, Russia
University Clinic of Kirov SMU
Kirov, 610035, Russia
Clinical Medical Center of A.I. Yevdokimov MSMSU
Moscow, 111398, Russia
Federal State Autonomous Institution National Medical Research Centre of Childrens 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 SofĂa, Servicio Dermatologia
CĂ³rdoba, 14004, Spain
Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia
CĂ³rdoba, 14004, Spain
Servicio Radiologia, Hospital Universitario Reina Sofia
CĂ³rdoba, 14004, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe
Valencia, 46026, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Chung-Shan Medical University Hospital
Taichung, 40201, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Memorial Hospital-Linkou Branch
Taoyuan, 333, Taiwan
Brighton and Sussex University Hospitals NHS Trust
Brighton, EAST Sussex, BN2 5BE, United Kingdom
Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital
Southampton, Hampshire, SO14 0YG, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE, United Kingdom
NHS Tayside Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF, United Kingdom
Southampton University Hospital NHS Foundation Trust, University Hospital Southampton
Hampshire, SO16 6YD, United Kingdom
Harley Grove Medical Centre
London, E3 2AT, 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 (10)
Mostaghimi A, Gibson A, Dwyer G, Oluboyede Y, Mazar I, Gorbatenko-Roth K, Law E. Exploring Factors That Influence the Measurement of Patient-Reported Impacts of Alopecia Areata. Dermatol Ther (Heidelb). 2025 Jun;15(6):1391-1403. doi: 10.1007/s13555-025-01400-7. Epub 2025 Apr 22.
PMID: 40261547DERIVEDKing 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: 39962358DERIVEDSinclair R, Mesinkovska N, Mitra D, Wajsbrot D, Law EH, Wolk R, King B. Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial. Am J Clin Dermatol. 2025 Jan;26(1):109-119. doi: 10.1007/s40257-024-00899-4. Epub 2024 Oct 23.
PMID: 39441519DERIVEDMesinkovska N, King B, Zhang X, Guttman-Yassky E, Magnolo N, Sinclair R, Mizuashi M, Shapiro J, Peeva E, Banerjee A, Takiya L, Cox LA, Wajsbrot D, Kerkmann U, Law E, Wolk R, Schaefer G. Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis. J Dermatol. 2024 Nov;51(11):1414-1424. doi: 10.1111/1346-8138.17442. Epub 2024 Sep 27.
PMID: 39328096DERIVEDFu J, Egeberg A, Holmes S, Vano-Galvan S, Steinhoff M, Edwards R, Bonfanti G, Nagra R, Wolk R, Tran H, Law E. Impact of Previous Alopecia Areata Treatment on Efficacy Responses up to Week 48 Following Ritlecitinib Treatment: A Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2759-2769. doi: 10.1007/s13555-024-01260-7. Epub 2024 Sep 10.
PMID: 39254890DERIVEDKing 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: 38263353DERIVEDWojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
PMID: 37917289DERIVEDThaci D, Tziotzios C, Ito T, Ko J, Karadag AS, Fang H, Edwards RA, Bonfanti G, Wolk R, Tran H, Law E. Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study. Dermatol Ther (Heidelb). 2023 Nov;13(11):2621-2634. doi: 10.1007/s13555-023-00997-x. Epub 2023 Sep 14.
PMID: 37707764DERIVEDKing B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. A plain language summary on ritlecitinib treatment for adults and adolescents with alopecia areata. Immunotherapy. 2023 Oct;15(14):1093-1103. doi: 10.2217/imt-2023-0069. Epub 2023 Jul 5.
PMID: 37403610DERIVEDKing B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529. doi: 10.1016/S0140-6736(23)00222-2. Epub 2023 Apr 14.
PMID: 37062298DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.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 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 7, 2018
Study Start
December 3, 2018
Primary Completion
December 31, 2020
Study Completion
June 24, 2021
Last Updated
February 24, 2022
Results First Posted
February 24, 2022
Record last verified: 2022-02
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.