Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-LT)
Alopecia Areata
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia, Alopecia Areata, Alopecia totalis, Alopecia universalis, Hair loss, JAK inhibitor, PF-06651600, Ritlecitinib
Eligibility Criteria
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
Sites / Locations
- The University of Alabama at Birmingham Hosptial Outreach Lab
- The University of Alabama at Birmingham
- The University of Alabama at Birmingham, Department of Dermatology
- Mosaic Dermatology
- Univ of California, Irvine, Dermatology Clinical Research Center
- Dermatology Specialists Inc.
- University of California, San Francisco
- Kaiser Permanente Clinical Trials Unit
- Southern California Dermatology, Inc.
- University of Colorado Anschutz Medical Campus
- University of Colorado Hospital Clinical and Translational Research Center
- University of Colorado Hospital Outpatient Pavilion
- Yale School of Medicine
- Investigational Drug Services
- Yale School of Medicine, Yale Center for Clinical Investigations
- Yale School of Medicine, Yale Center for Clinical Investigation
- Medstar Georgetown University Hospital - Department of Otolaryngology
- Medstar Georgetown University Hospital-Dept of Otolaryngology
- Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
- MedStar Washington Hospital Center
- Medstar Georgetown University Hospital - Department of Pediatrics
- Siperstein Dermatology Group
- Park Avenue Dermatology
- ForCare Clinical Research
- Velocity Clinical Research - Boise
- Northwestern Medical Group
- Northwestern Medicine Diagnostic Testing Center
- Northwestern Medicine
- Northwestern Memorial Hospital Investigational Drug Service Pharmacy
- Northwestern Memorial Hospital
- Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
- NorthShore University HealthSystem Dermatology Clinical Trials Unit
- Northshore University HealthSystem/Dermatology
- Southern Illinois University School of Medicine
- Dawes Fretzin Clinical Research Group, LLC
- University of Iowa Hospitals and Clinics
- Medstar Georgetown University Hospital - Department of Dermatology
- Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
- University of Minnesota Clinical Research Unit (CRU)
- University of Minnesota Lillehei Clinical Research Unit (LCRU)
- University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
- Skin Specialists PC
- Schweiger Dermatology Group
- NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
- Pura Dermatology (in c/o TrialSpark, Inc)
- Icahn School of Medicine at Mount Sinai
- UNC CTRC
- UNC Hospitals, Investigational Drug Service
- UNC Dermatology and Skin Cancer Center
- UNC Dermatology Clinical Trials Unit
- Cleveland Clinic Foundation
- Vital Prospects Clinical Research Institute, P.C.
- Oregon Medical Research Center
- The University of Texas Health Science Center at Houston
- Tamjidi Skin Institute (in c/o TrialSpark, Inc)
- CINME Centro de Investigaciones Metabolicas
- Psoriahue Medicina Interdisciplinaria
- Premier Specialists Pty Ltd
- St George Dermatology & Skin Cancer Centre
- The Skin Centre
- Veracity Clinical Research Pty Ltd
- Skin Health Institute
- Sinclair Dermatology
- Royal Melbourne Hospital, Melbourne Health
- Royal Melbourne Hospital
- Royal Melbourne Hospital, Melbourne Health
- Wiseman Dermatology Research Inc.
- Eastern Canada Cutaneous Research Associates Ltd.
- Guenther Research Inc
- Lynderm Research Inc.
- Lynderm Research Inc.
- The Centre for Clinical Trials
- SKiN Centre for Dermatology
- York Dermatology Clinic and Research Centre
- Medicor Research Inc
- Medicor Research Inc
- Sudbury Skin Clinique
- Research Toronto
- Research Toronto
- Innovaderm Research Inc.
- Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
- Centro Medico Skin Med
- Centro Internacional de Estudios Clinicos - CIEC
- Medical Skin Center
- Clinica Dermacross S.A.
- Beijing Friendship Hospital, Capital Medical University
- Peking University Third Hospital
- The First Affiliated Hospital, Sun Yat-sen University
- The University of Hong Kong - Shenzhen Hospital
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- The First Affiliated Hospital with Nanjing Medical University
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
- The First Affiliated Hospital of College of Medicine, Zhejiang University
- Fundacion Centro de Investigacion Clinica CIC
- Fundacion Hospitalaria San Vicente de Paul
- Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
- DERMAMEDICA s.r.o.
- Fakultni nemocnice Olomouc
- Clintrial s.r.o.
- Sanatorium profesora Arenbergera
- Fachklinik Bad Bentheim
- Fachklinik Bad Bentheim
- Emovis GmbH
- Universitaetsklinikum Erlangen
- University Hospital Frankfurt
- University Hospital Schleswig-Holstein
- University Hospital Muenster
- Nagoya City University Hospital
- Tohoku University Hospital
- Hamamatsu University Hospital
- Juntendo Tokyo Koto Geriatric Medical Center
- Kyorin University Hospital
- Osaka Metropolitan University Hospital
- Tokyo Medical University Hospital
- Pusan National University Hospital
- Seoul National University Hospital
- Sociedad de Metabolismo y Corazon S.C.
- Hospital D Maria
- McBk S.C.
- Centermed Krakow Sp.z o.o.
- Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
- Dermedic Jacek Zdybski
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- RCMed Oddzial Warszawa
- Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
- ETG Warszawa
- Royalderm Agnieszka Nawrocka
- EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
- Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
- Centrum Medyczne OPOROW
- State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"
- University Clinic of Kirov SMU
- Clinical Medical Center of Moscow State University of Medicine and Dentistry
- Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"
- State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
- Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
- Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
- Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
- State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital
- Hospital Universitari Germans Trias i Pujol
- Hospital del Mar
- Hospital Universitario Reina Sofia
- Hospital Universitario Infanta Leonor
- Hospital Universitario La Paz: Servicio de Farmacia
- Hospital Universitario La Paz
- Hospital Universitario y Politecnico La Fe
- Chung-Shan Medical University Hospital
- Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
- National Taiwan University Hospital
- Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
- University Hospital Southampton NHS Foundation Trust
- University Hospital Southampton NHS Foundation Trust
- University Hospitals Sussex NHS Foundation Trust (UHSussex)
- NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
- Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital
- Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital
- Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Treatment sequence 1
Treatment sequence 2
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.
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.