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PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06651600 Induction Dose
PF-06651600 Maintenance Dose #1
PF-06651600 Maintenance Dose #2
PF-06651600 Maintenance Dose #3
Placebo
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 totalis, Alopecia universalis, Patchy hair loss, Diffuse hair loss, Hair loss, Hair disease, PF-06651600, Ritlecitinib

Eligibility Criteria

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

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

Sites / Locations

  • The University of Alabama at Birmingham Hospital Outreach Lab
  • The University of Alabama at Birmingham, Department of Dermatology
  • The University of Alabama at Birmingham, Department of Dermatology
  • Mosaic Dermatology
  • University of California, Irvine, Department of Dermatology, 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 Pavillion
  • Yale School of Medicine
  • Church Street Research Unit
  • Medstar Georgetown University Hospital Center-Department of Otolaryngology
  • Medstar Washington Hospital Center-Claude Nogay Research Pharmacy
  • Medstar Washington Hospital Center
  • Medstar Georgetown University Hospital Center-Department of Pediatrics
  • Siperstein Dermatology Group
  • Park Avenue Dermatology
  • ForCare Clinical Research
  • Advanced Clinical Research
  • Northwestern Medical Group
  • Northwestern Medicine Diagnostic Testing Center
  • Northwestern Medicine
  • Northwestern Memorial Hospital, Investigational Research Pharmacy
  • Northwestern University
  • NorthShore University HealthSystem
  • Southern Illinois University School of Medicine
  • Dawes Fretzin Clinical Research Group, LLC
  • University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS;
  • University of Iowa Hospitals and Clinics
  • Medstar Georgetown University Hospital - Department of Dermatology
  • Massachusetts General Hospital
  • University of Minnesota Department of Dermatology
  • University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke
  • Skin Specialists, PC
  • The Dermatology Group, P.C.
  • NYU School of Medicine, The Ronald O. Perelman Department of Dermatology
  • Icahn School of Medicine at Mount Sinai
  • UNC CTRC
  • UNC Hospitals, Investigational Drug Service
  • UNC Dermatology Clinical Trials Unit
  • Cleveland Clinic Foundation
  • Vital Prospects Clinical Research Institute, P.C
  • The University of Texas Health Science Center at Houston
  • CINME Centro de Investigaciones Metabolicas
  • Psoriahue Medicina Interdisciplinaria
  • Premier Specialists Pty Ltd
  • St George Dermatology and Skin Cancer Centre
  • The Skin Centre
  • Veracity Clinical Research Pty Ltd
  • Skin Health Institute
  • Sinclair Dermatology
  • The Royal Melbourne Hospital
  • Royal Park Campus
  • Wiseman Dermatology Research Inc.
  • Eastern Canada Cutaneous Research Associates Ltd.
  • Guenther Research Inc
  • Lynderm Research Inc.
  • The Centre for Clinical Trials
  • SKiN Centre for Dermatology
  • York Dermatology Clinic and Research Centre
  • Medicor Research Inc
  • Sudbury Skin Clinique
  • Research Toronto
  • Innovaderm Research Inc.
  • Centre de Recherche Dermatologique du Quebec metropolitain
  • Centro Internacional de Estudios Clinicos, CIEC
  • Centro Medico Skin Med
  • Clinica Dermacross S.A.
  • Medical Skin Center
  • Peking University First Hospital
  • 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
  • Huashan Hospital, Fudan University/Dermatology Department
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept
  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Fundacion Centro de Investigacion Clinica CIC
  • Fundacion Hospitalaria San Vicente de Paul
  • Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
  • DERMAMEDICA s.r.o.
  • Fakultni nemocnice Olomouc
  • Clintrial s.r.o.
  • Sanatorium profesora Arenbergera
  • Nemocnice Na Bulovce
  • Fachklinik Bad Bentheim
  • Emovis GmbH
  • Universitaetsklinikum Erlangen
  • University Hospital Frankfurt
  • University Hospital Schleswig-Holstein
  • University Hospital Muenster
  • Semmelweis Egyetem
  • Debreceni Egyetem
  • Bugat Pal Korhaz, Borgyogyaszat
  • Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar
  • Nagoya City University Hospital - Dermatology
  • Tohoku University hospital
  • Hamamatsu University Hospital
  • Juntendo Tokyo Koto Geriatric Medical Center
  • Tokyo Medical University Hospital
  • Osaka City University Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Sociedad de Metabolismo y Corazon S.C.
  • Hospital D'Maria
  • Centermed Krakow Sp.z o.o.
  • Medicover Sp.z.o.o
  • Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
  • Sanova Audiological Care Polska Sp.z.o.o
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • RCMed Oddzial Warszawa
  • Royalderm Agnieszka Nawrocka
  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
  • State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
  • University Clinic of Kirov SMU
  • Clinical Medical Center of A.I. Yevdokimov MSMSU
  • Federal State Autonomous Institution National Medical Research Centre of Childrens 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 Sofía, Servicio Dermatologia
  • Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia
  • Servicio Radiologia, Hospital Universitario Reina Sofia
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario La Paz
  • Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe
  • Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe
  • Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe
  • CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
  • Chung Shan Medical University Hospital
  • Chung-Shan Medical University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital-Linkou Branch
  • Brighton and Sussex University Hospitals NHS Trust
  • Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital
  • Brighton and Sussex University Hospitals NHS Trust
  • NHS Tayside Ninewells Hospital
  • NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital
  • NHS Greater Glasgow and Clyde
  • Southampton University Hospital NHS Foundation Trust, University Hospital Southampton
  • Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital,
  • Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital,
  • Harley Grove Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence A

Sequence B

Sequence C

Sequence D

Sequence E

Sequence F

Sequence G

Arm Description

Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks

Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks

Maintenance dose #1 given QD for 48 weeks

Maintenance dose #2 given QD for 48 weeks

Maintenance dose #3 given QD for 48 weeks

Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks

Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported.

Secondary Outcome Measures

Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
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
The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
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
The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
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
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
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
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.
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
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Change From Baseline in SALT Score at Week 28, 34, 40, and 48
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
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
EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.
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
ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.
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
PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
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
AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations
AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
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
AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.

Full Information

First Posted
November 5, 2018
Last Updated
February 1, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03732807
Brief Title
PF-06651600 for the Treatment of Alopecia Areata
Acronym
ALLEGRO-2b/3
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 24, 2021 (Actual)

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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
718 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
Arm Title
Sequence C
Arm Type
Experimental
Arm Description
Maintenance dose #1 given QD for 48 weeks
Arm Title
Sequence D
Arm Type
Experimental
Arm Description
Maintenance dose #2 given QD for 48 weeks
Arm Title
Sequence E
Arm Type
Experimental
Arm Description
Maintenance dose #3 given QD for 48 weeks
Arm Title
Sequence F
Arm Type
Experimental
Arm Description
Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
Arm Title
Sequence G
Arm Type
Experimental
Arm Description
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
Intervention Type
Drug
Intervention Name(s)
PF-06651600 Induction Dose
Intervention Description
Oral tablets taken once daily (QD)
Intervention Type
Drug
Intervention Name(s)
PF-06651600 Maintenance Dose #1
Intervention Description
Oral tablets taken QD
Intervention Type
Drug
Intervention Name(s)
PF-06651600 Maintenance Dose #2
Intervention Description
Oral tablets taken QD
Intervention Type
Drug
Intervention Name(s)
PF-06651600 Maintenance Dose #3
Intervention Description
Oral tablets taken QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets taken QD
Primary Outcome Measure Information:
Title
Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
Time Frame
Week 24
Title
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
Time Frame
Week 24
Title
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
Description
PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
Time Frame
Week 24
Title
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
Description
The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Time Frame
Week 24
Title
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
Description
The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Time Frame
Week 24
Title
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
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Time Frame
Week 4, 8, 12, 18, 28, 34, 40, and 48
Title
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
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.
Time Frame
Week 4, 8, 12, 18, 28, 34, 40, and 48
Title
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
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.
Time Frame
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Title
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 4, 8, 12, 18, and 24
Title
Change From Baseline in SALT Score at Week 28, 34, 40, and 48
Description
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 28, 34, 40, and 48
Title
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
Description
EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.
Time Frame
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Title
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
Description
ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.
Time Frame
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Title
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
Description
PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
Time Frame
Week 4, 8, 12, 18, 24, 34, 40, and 48
Title
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
Description
AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 4, 8, 12, 18, and 24
Title
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations
Description
AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 34, 40, and 48
Title
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
Description
AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.
Time Frame
Week 4, 8, 12, 18, 24, 34, 40, and 48
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
Description
HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 4, 8, 12, and 24
Title
Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
Description
HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 48
Title
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24
Description
HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 4, 8, 12, and 24
Title
Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48
Description
HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
Time Frame
Baseline (Day 1), Week 48
Title
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
Description
HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms.
Time Frame
Week 4, 8, 12, 24 and 48
Title
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
Description
HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms.
Time Frame
Week 4, 8, 12, 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
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 Hospital Outreach Lab
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
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
University of California, Irvine, Department of Dermatology, 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 Pavillion
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
Church Street Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Medstar Georgetown University Hospital Center-Department 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 Center-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
Advanced Clinical Research
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 Research Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University HealthSystem
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; Department of Pharmacy-IDS;
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Minnesota Department of Dermatology
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
The Dermatology Group, P.C.
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
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 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
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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 and 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
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Park Campus
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 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
P3A1W8
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 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
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Centro Internacional de Estudios Clinicos, CIEC
City
Santiago
State/Province
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Centro Medico Skin Med
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
7580206
Country
Chile
Facility Name
Clinica Dermacross S.A.
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Medical Skin Center
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2530900
Country
Chile
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
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
Huashan Hospital, Fudan University/Dermatology Department
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
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
The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
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 Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
City
Bogota
State/Province
D.c.
ZIP/Postal Code
110221
Country
Colombia
Facility Name
DERMAMEDICA s.r.o.
City
Nachod
ZIP/Postal Code
54701
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
11000
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha 8- Liben
ZIP/Postal Code
180 81
Country
Czechia
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
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bugat Pal Korhaz, Borgyogyaszat
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Nagoya City University Hospital - Dermatology
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
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
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
C.P. 91900
Country
Mexico
Facility Name
Hospital D'Maria
City
Veracruz
ZIP/Postal Code
CP. 91910
Country
Mexico
Facility Name
Centermed Krakow Sp.z o.o.
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Medicover Sp.z.o.o
City
Lodz
ZIP/Postal Code
90-368
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
Sanova Audiological Care Polska Sp.z.o.o
City
Lodz
ZIP/Postal Code
91-867
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
02-657
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Facility Name
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
City
Wroclaw
ZIP/Postal Code
50-566
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 A.I. Yevdokimov MSMSU
City
Moscow
ZIP/Postal Code
111398
Country
Russian Federation
Facility Name
Federal State Autonomous Institution National Medical Research Centre of Childrens 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 Sofía, Servicio Dermatologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Servicio Radiologia, 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
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch
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
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Chung-Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital-Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
State/Province
EAST Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
NHS Tayside Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
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
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Southampton University Hospital NHS Foundation Trust, University Hospital Southampton
City
Hampshire
ZIP/Postal Code
SO16 6YD
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
Facility Name
Harley Grove Medical Centre
City
London
ZIP/Postal Code
E3 2AT
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=B7981015
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

PF-06651600 for the Treatment of Alopecia Areata

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