Clinical trial NCT03732807: PF-06651600 for the Treatment of Alopecia Areata
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia
Alopecia totalis
Alopecia universalis
Patchy hair loss
Diffuse hair loss
Hair loss
Hair disease
PF-06651600
Ritlecitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 718
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of alopecia areata with no other cause of hair loss
* ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
* Current episode of hair loss ≤10 years

Exclusion Criteria:

* Other types of alopecia or other diseases that can cause hair loss
* Other scalp diseases that could interfere with assessment of hair loss/regrowth
* Subjects with shaved heads must not enter the study until hair has grown back \& is considered stable by the investigator
* Any previous use of any Janus kinase (JAK) inhibitor

Primary outcomes:
measure: Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
timeFrame: Week 24
measure: Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
timeFrame: Week 24
measure: Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 28, 34, 40, and 48
measure: Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 28, 34, 40, and 48
measure: Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
measure: Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
timeFrame: Baseline (Day 1), Week 4, 8, 12, 18, and 24
measure: Change From Baseline in SALT Score at Week 28, 34, 40, and 48
timeFrame: Baseline (Day 1), Week 28, 34, 40, and 48
measure: Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
measure: Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
measure: Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 24, 34, 40, and 48
measure: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations
timeFrame: Baseline (Day 1), Week 4, 8, 12, 18, and 24
measure: Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations
timeFrame: Baseline (Day 1), Week 34, 40, and 48
measure: Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48
timeFrame: Week 4, 8, 12, 18, 24, 34, 40, and 48
Other outcomes:
measure: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
timeFrame: Baseline (Day 1), Week 4, 8, 12, and 24
measure: Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
timeFrame: Baseline (Day 1), Week 48
measure: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
timeFrame: Baseline (Day 1), Week 4, 8, 12, and 24
measure: Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
timeFrame: Baseline (Day 1), Week 48
measure: Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48
timeFrame: Week 4, 8, 12, 24 and 48
measure: Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48
timeFrame: Week 4, 8, 12, 24 and 48
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Hospital Outreach Lab
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham, Department of Dermatology
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham, Department of Dermatology
state: Alabama
city: Beverly Hills
country: United States
facility: Mosaic Dermatology
state: California
city: Irvine
country: United States
facility: University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center
state: California
city: Murrieta
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Clinical Trials Unit
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital Clinical and Translational Research Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital Outpatient Pavillion
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Church Street Research Unit
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital Center-Department of Otolaryngology
state: District of Columbia
city: Washington
country: United States
facility: Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
state: District of Columbia
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Medstar Georgetown University Hospital Center-Department of Pediatrics
state: District of Columbia
city: Boynton Beach
country: United States
facility: Siperstein Dermatology Group
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medicine Diagnostic Testing Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital, Investigational Research Pharmacy
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS;
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Chevy Chase
country: United States
facility: Medstar Georgetown University Hospital - Department of Dermatology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: New York
country: United States
facility: NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: UNC CTRC
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals, Investigational Drug Service
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Dermatology Clinical Trials Unit
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C
state: Oklahoma
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Caba
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas
state: Buenos Aires
city: Caba
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Park Campus
state: Victoria
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd.
state: Nova Scotia
city: London
country: Canada
facility: Guenther Research Inc
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinique
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos, CIEC
state: Recoleta
city: Santiago
country: Chile
facility: Centro Medico Skin Med
state: Región Metropolitana
city: Santiago
country: Chile
facility: Clinica Dermacross S.A.
state: Región Metropolitana
city: Vina del Mar
country: Chile
facility: Medical Skin Center
state: Valparaiso
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong - Shenzhen Hospital
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University/Dermatology Department
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept
state: Zhejiang
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC
state: Antioquia
city: Medellin
country: Colombia
facility: Fundacion Hospitalaria San Vicente de Paul
state: Antioquia
city: Bogota
country: Colombia
facility: Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
state: D.c.
city: Nachod
country: Czechia
facility: DERMAMEDICA s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Clintrial s.r.o.
city: Praha 1
country: Czechia
facility: Sanatorium profesora Arenbergera
city: Praha 8- Liben
country: Czechia
facility: Nemocnice Na Bulovce
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Emovis GmbH
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
city: Luebeck
country: Germany
facility: University Hospital Schleswig-Holstein
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz, Borgyogyaszat
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar
city: Nagoya
country: Japan
facility: Nagoya City University Hospital - Dermatology
state: Aichi
city: Sendai
country: Japan
facility: Tohoku University hospital
state: Miyagi
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Koto-ku
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
city: Veracruz
country: Mexico
facility: Hospital D'Maria
city: Krakow
country: Poland
facility: Centermed Krakow Sp.z o.o.
city: Lodz
country: Poland
facility: Medicover Sp.z.o.o
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
city: Lodz
country: Poland
facility: Sanova Audiological Care Polska Sp.z.o.o
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: RCMed Oddzial Warszawa
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
city: Kirov
country: Russian Federation
facility: University Clinic of Kirov SMU
city: Moscow
country: Russian Federation
facility: Clinical Medical Center of A.I. Yevdokimov MSMSU
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Institution National Medical Research Centre of Childrens Health
city: Rostov-on-Don
country: Russian Federation
facility: State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
city: Saint Petersburg,
country: Russian Federation
facility: Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
city: Yaroslavl
country: Russian Federation
facility: State Autonomous Healthcare Institution of the Yaroslavl Region Clinical Emergency Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía, Servicio Dermatologia
city: Cordoba
country: Spain
facility: Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia
city: Cordoba
country: Spain
facility: Servicio Radiologia, Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe
city: Valencia
country: Spain
facility: Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe
city: Valencia
country: Spain
facility: Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe
city: Kaohsiung City
country: Taiwan
facility: CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung-Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital-Linkou Branch
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
state: EAST Sussex
city: Southampton
country: United Kingdom
facility: Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital
state: Hampshire
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Hampshire
country: United Kingdom
facility: Southampton University Hospital NHS Foundation Trust, University Hospital Southampton
city: London,
country: United Kingdom
facility: Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital,
city: London,
country: United Kingdom
facility: Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital,
city: London
country: United Kingdom
facility: Harley Grove Medical Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: