Clinical trial NCT04006457: Long-Term PF-06651600 for the Treatment of Alopecia Areata
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia
Alopecia Areata
Alopecia totalis
Alopecia universalis
Hair loss
JAK inhibitor
PF-06651600
Ritlecitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 1052
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of subjects reporting treatment-emergent adverse events
timeFrame: Baseline through Month 36
measure: Number of subjects reporting serious adverse events
timeFrame: Baseline through Month 36
measure: Number of subjects reporting adverse events leading to discontinuation
timeFrame: Baseline through Month 36
measure: Number of subjects with clinically significant abnormalities in vital signs
timeFrame: Baseline through Month 36
measure: Number of subjects with clinically significant abnormalities in clinical laboratory values
timeFrame: Baseline through Month 36
measure: Vaccine sub-study: Percentage of subjects with a tetanus booster response
timeFrame: Vaccine sub-study Month 1
Secondary outcomes:
measure: Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10
timeFrame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
measure: Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20
timeFrame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
measure: Change from baseline in SALT score
timeFrame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
measure: Percentage of subjects with a 75% improvement in SALT score from baseline
timeFrame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
measure: Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score
timeFrame: Months 1, 3, 6, 12, 18, 24, and 36
measure: Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score
timeFrame: Months 1, 3, 6, 12, 18, 24, and 36
measure: Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved"
timeFrame: Months 1, 3, 6, 9, 12, 18, 24, and 36
measure: Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains
timeFrame: Months 1, 3, 6, 9, 12, 18, 24, and 36
measure: Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Months 1, 3, 6, 9, 12, 18, 24, and 36
measure: Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Months 1, 3, 6, 9, 12, 18, 24, and 36
measure: Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of depression who achieved a "normal" subscale score indicative of an absence of depression
timeFrame: Months 1, 3, 6, 9, 12, 18, 24, and 36
measure: Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of anxiety who achieved a "normal" subscale score indicative of an absence of anxiety
timeFrame: Months 1, 3, 6, 9, 12, 18, 24, and 36
measure: Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥1.0 IU/mL
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥0.1 IU/mL
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Percentage of subjects with ≥4x increase in anti-tetanus antibody level from baseline
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Percentage of subjects with ≥1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C
timeFrame: Vaccine sub-study Day 1 and Month 1
measure: Number of subjects reporting treatment-emergent adverse events
timeFrame: Month 37 through Month 60
measure: Number of subjects reporting serious adverse events
timeFrame: Month 37 through Month 60
measure: Number of subjects reporting adverse events leading to discontinuation
timeFrame: Month 37 through Month 60
measure: Number of subjects with clinically significant abnormalities in vital signs
timeFrame: Month 37 through Month 60
measure: Number of subjects with clinically significant abnormalities in clinical laboratory values
timeFrame: Month 37 through Month 60
measure: Vaccine sub-study: Number of subjects reporting serious adverse events
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Number of subjects reporting adverse events
timeFrame: Vaccine sub-study Month 1
measure: Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation
timeFrame: Vaccine sub-study Month 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Hosptial Outreach Lab
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
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: Univ of California, Irvine, 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 Pavilion
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine, Yale Center for Clinical Investigations
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital - Department of Otolaryngology
state: District of Columbia
city: Washington
country: United States
facility: Medstar Georgetown University Hospital-Dept of Otolaryngology
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 - 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: Velocity Clinical Research - Boise
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 Drug Service Pharmacy
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology Clinical Trials Unit
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
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 - Clinical Unit for Research Trials in Skin (CURTIS)
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Clinical Research Unit (CRU)
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Lillehei Clinical Research Unit (LCRU)
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 (Schlessinger MD)
state: Nebraska
city: Verona
country: United States
facility: Schweiger Dermatology, 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: Pura Dermatology (in c/o TrialSpark, Inc)
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 Dermatology and Skin Cancer Center
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: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Vienna
country: United States
facility: Tamjidi Skin Institute (in c/o TrialSpark, Inc)
state: Virginia
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 & 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: Royal Melbourne Hospital
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: 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 (CRDQ)
city: Santiago
country: Chile
facility: Centro Medico Skin Med
state: LAS Condes
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC
state: Recoleta
city: Santiago
country: Chile
facility: Clinica Dermacross S.A.
state: Vitacura
city: Vina del Mar
country: Chile
facility: Medical Skin Center
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: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
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 D.C.
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
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: 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: Nagoya
country: Japan
facility: Nagoya City University Hospital
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: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical 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: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Grodzisk Mazowiecki
country: Poland
facility: McBk S.C.
city: Krakow
country: Poland
facility: Centermed Krakow Sp.z o.o.
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Warszawa
country: Poland
facility: RCMed Oddzial Warszawa
city: Warszawa
country: Poland
facility: Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
city: Wroclaw
country: Poland
facility: Centrum Medyczne OPOROW
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: FSBEI HE Russian University of Medicine of the MoH of Russia
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Institution "National Medical Research Centre of Children's' 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 "Centre Vitiligo" ("Centre Vitiligo" LLC)
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
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 Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz: Servicio de Farmacia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Taichung
country: Taiwan
facility: Chung-Shan Medical University Hospital
state: R.o.c.
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
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: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust (UHSussex)
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
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, St Thomas' Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: