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Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-LT)

Primary Purpose

Alopecia Areata

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-06651600
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

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

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Treatment sequence 1

Treatment sequence 2

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of subjects reporting treatment-emergent adverse events
Number of subjects reporting serious adverse events
Number of subjects reporting adverse events leading to discontinuation
Number of subjects with clinically significant abnormalities in vital signs
Number of subjects with clinically significant abnormalities in clinical laboratory values
Vaccine sub-study: Percentage of subjects with a tetanus booster response
Tetanus booster response is defined as 1) ≥4 fold rise in anti-tetanus toxoid IgG antibody concentration at Day 30 if the pre-vaccination concentration was ≤2.7 IU/mL; 2) ≥2 fold rise in anti tetanus toxoid IgG antibody if the pre-vaccination concentration was >2.7 IU/mL

Secondary Outcome Measures

Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Change from baseline in SALT score
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of subjects with a 75% improvement in SALT score from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score
EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score
ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved"
PGI-C is a self administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has: …", with 7 responses ranging from "greatly improved" to "greatly worsened."
Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains
The AAPPO scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.
Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS)
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
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
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
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
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response
Meningococcal serogroup C response is defined as achieving ≥1:8 human serum bactericidal activity (hSBA) (in participants with undetectable pre-vaccination assay titers)
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥1.0 IU/mL
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥0.1 IU/mL
Vaccine sub-study: Percentage of subjects with ≥4x increase in anti-tetanus antibody level from baseline
Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values
Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels
Vaccine sub-study: Percentage of subjects with ≥1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C
Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C
Number of subjects reporting treatment-emergent adverse events
Number of subjects reporting serious adverse events
Number of subjects reporting adverse events leading to discontinuation
Number of subjects with clinically significant abnormalities in vital signs
Number of subjects with clinically significant abnormalities in clinical laboratory values
Vaccine sub-study: Number of subjects reporting serious adverse events
Vaccine sub-study: Number of subjects reporting adverse events
Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation

Full Information

First Posted
July 1, 2019
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04006457
Brief Title
Long-Term PF-06651600 for the Treatment of Alopecia Areata
Acronym
ALLEGRO-LT
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
July 8, 2024 (Anticipated)
Study Completion Date
February 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia, Alopecia Areata, Alopecia totalis, Alopecia universalis, Hair loss, JAK inhibitor, PF-06651600, Ritlecitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1051 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment sequence 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment sequence 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-06651600
Intervention Description
50 mg oral tablets/capsules
Intervention Type
Biological
Intervention Name(s)
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Intervention Description
Single intramuscular injection administered to patients participating in the vaccine sub-study
Intervention Type
Biological
Intervention Name(s)
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Intervention Description
Single intramuscular injection administered to patients participating in the vaccine sub-study
Primary Outcome Measure Information:
Title
Number of subjects reporting treatment-emergent adverse events
Time Frame
Baseline through Month 36
Title
Number of subjects reporting serious adverse events
Time Frame
Baseline through Month 36
Title
Number of subjects reporting adverse events leading to discontinuation
Time Frame
Baseline through Month 36
Title
Number of subjects with clinically significant abnormalities in vital signs
Time Frame
Baseline through Month 36
Title
Number of subjects with clinically significant abnormalities in clinical laboratory values
Time Frame
Baseline through Month 36
Title
Vaccine sub-study: Percentage of subjects with a tetanus booster response
Description
Tetanus booster response is defined as 1) ≥4 fold rise in anti-tetanus toxoid IgG antibody concentration at Day 30 if the pre-vaccination concentration was ≤2.7 IU/mL; 2) ≥2 fold rise in anti tetanus toxoid IgG antibody if the pre-vaccination concentration was >2.7 IU/mL
Time Frame
Vaccine sub-study Month 1
Secondary Outcome Measure Information:
Title
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Title
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Title
Change from baseline in SALT score
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Title
Percentage of subjects with a 75% improvement in SALT score from baseline
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Title
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score
Description
EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Time Frame
Months 1, 3, 6, 12, 18, 24, and 36
Title
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score
Description
ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Time Frame
Months 1, 3, 6, 12, 18, 24, and 36
Title
Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved"
Description
PGI-C is a self administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has: …", with 7 responses ranging from "greatly improved" to "greatly worsened."
Time Frame
Months 1, 3, 6, 9, 12, 18, 24, and 36
Title
Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains
Description
The AAPPO scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.
Time Frame
Months 1, 3, 6, 9, 12, 18, 24, and 36
Title
Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS)
Description
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Months 1, 3, 6, 9, 12, 18, 24, and 36
Title
Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)
Description
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Months 1, 3, 6, 9, 12, 18, 24, and 36
Title
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
Description
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Months 1, 3, 6, 9, 12, 18, 24, and 36
Title
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
Description
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame
Months 1, 3, 6, 9, 12, 18, 24, and 36
Title
Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response
Description
Meningococcal serogroup C response is defined as achieving ≥1:8 human serum bactericidal activity (hSBA) (in participants with undetectable pre-vaccination assay titers)
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥1.0 IU/mL
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥0.1 IU/mL
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Percentage of subjects with ≥4x increase in anti-tetanus antibody level from baseline
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Percentage of subjects with ≥1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C
Time Frame
Vaccine sub-study Day 1 and Month 1
Title
Number of subjects reporting treatment-emergent adverse events
Time Frame
Month 37 through Month 60
Title
Number of subjects reporting serious adverse events
Time Frame
Month 37 through Month 60
Title
Number of subjects reporting adverse events leading to discontinuation
Time Frame
Month 37 through Month 60
Title
Number of subjects with clinically significant abnormalities in vital signs
Time Frame
Month 37 through Month 60
Title
Number of subjects with clinically significant abnormalities in clinical laboratory values
Time Frame
Month 37 through Month 60
Title
Vaccine sub-study: Number of subjects reporting serious adverse events
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Number of subjects reporting adverse events
Time Frame
Vaccine sub-study Month 1
Title
Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation
Time Frame
Vaccine sub-study Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham Hosptial Outreach Lab
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
The University of Alabama at Birmingham, Department of Dermatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mosaic Dermatology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Univ of California, Irvine, Dermatology Clinical Research Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Dermatology Specialists Inc.
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Clinical Trials Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital Clinical and Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Investigational Drug Services
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale School of Medicine, Yale Center for Clinical Investigations
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Yale School of Medicine, Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Medstar Georgetown University Hospital - Department of Otolaryngology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Medstar Georgetown University Hospital-Dept of Otolaryngology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Medstar Georgetown University Hospital - Department of Pediatrics
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Siperstein Dermatology Group
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Velocity Clinical Research - Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern Medical Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Medicine Diagnostic Testing Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital Investigational Drug Service Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
NorthShore University HealthSystem Dermatology Clinical Trials Unit
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Northshore University HealthSystem/Dermatology
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Medstar Georgetown University Hospital - Department of Dermatology
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Minnesota Clinical Research Unit (CRU)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota Lillehei Clinical Research Unit (LCRU)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Skin Specialists PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Schweiger Dermatology Group
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Pura Dermatology (in c/o TrialSpark, Inc)
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
UNC CTRC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Hospitals, Investigational Drug Service
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Dermatology and Skin Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
UNC Dermatology Clinical Trials Unit
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Tamjidi Skin Institute (in c/o TrialSpark, Inc)
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
CINME Centro de Investigaciones Metabolicas
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
Psoriahue Medicina Interdisciplinaria
City
Caba
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Name
Premier Specialists Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
St George Dermatology & Skin Cancer Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Veracity Clinical Research Pty Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin Health Institute
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Royal Melbourne Hospital, Melbourne Health
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Melbourne Hospital, Melbourne Health
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Eastern Canada Cutaneous Research Associates Ltd.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z2
Country
Canada
Facility Name
Guenther Research Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
The Centre for Clinical Trials
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
York Dermatology Clinic and Research Centre
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Medicor Research Inc
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Medicor Research Inc
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 1X3
Country
Canada
Facility Name
Sudbury Skin Clinique
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 1X8
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Centro Medico Skin Med
City
Santiago
State/Province
LAS Condes
ZIP/Postal Code
7580206
Country
Chile
Facility Name
Centro Internacional de Estudios Clinicos - CIEC
City
Santiago
State/Province
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Medical Skin Center
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2530900
Country
Chile
Facility Name
Clinica Dermacross S.A.
City
Santiago
State/Province
Vitacura
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The University of Hong Kong - Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518053
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Fundacion Centro de Investigacion Clinica CIC
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050001
Country
Colombia
Facility Name
Fundacion Hospitalaria San Vicente de Paul
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
City
Bogota D.C.
ZIP/Postal Code
110221
Country
Colombia
Facility Name
DERMAMEDICA s.r.o.
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Clintrial s.r.o.
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Sanatorium profesora Arenbergera
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Lower Saxony
ZIP/Postal Code
48455
Country
Germany
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Hospital Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
University Hospital Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Juntendo Tokyo Koto Geriatric Medical Center
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Sociedad de Metabolismo y Corazon S.C.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Hospital D Maria
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
McBk S.C.
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Centermed Krakow Sp.z o.o.
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Dermedic Jacek Zdybski
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
RCMed Oddzial Warszawa
City
Warszawa
ZIP/Postal Code
00-892
Country
Poland
Facility Name
Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
City
Warszawa
ZIP/Postal Code
02-661
Country
Poland
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Facility Name
EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Centrum Medyczne OPOROW
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Facility Name
University Clinic of Kirov SMU
City
Kirov
ZIP/Postal Code
610035
Country
Russian Federation
Facility Name
Clinical Medical Center of Moscow State University of Medicine and Dentistry
City
Moscow
ZIP/Postal Code
111398
Country
Russian Federation
Facility Name
Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"
City
Rostov-on-Don
ZIP/Postal Code
344002
Country
Russian Federation
Facility Name
Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"
City
Saint Petersburg,
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)
City
Saint Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -
City
Saint Petersburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario La Paz: Servicio de Farmacia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Chung-Shan Medical University Hospital
City
Taichung
State/Province
R.o.c.
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospitals Sussex NHS Foundation Trust (UHSussex)
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7981032
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Long-Term PF-06651600 for the Treatment of Alopecia Areata

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