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

• ClinicalTrials.gov Identifier: NCT03732807
• Recruitment Status: Completed
• First Posted: November 7, 2018
• Results First Posted: February 24, 2022
• Last Update Posted: February 24, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Alopecia Areata	Drug: PF-06651600 Induction Dose; Drug: PF-06651600 Maintenance Dose #1; Drug: PF-06651600 Maintenance Dose #2; Drug: PF-06651600 Maintenance Dose #3; Drug: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 718 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 3, 2018
• Actual Primary Completion Date: December 31, 2020
• Actual Study Completion Date: June 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sequence A; Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks	Drug: PF-06651600 Induction Dose; Oral tablets taken once daily (QD); Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD
Experimental: Sequence B; Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks	Drug: PF-06651600 Induction Dose; Oral tablets taken once daily (QD); Drug: PF-06651600 Maintenance Dose #2; Oral tablets taken QD
Experimental: Sequence C; Maintenance dose #1 given QD for 48 weeks	Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD
Experimental: Sequence D; Maintenance dose #2 given QD for 48 weeks	Drug: PF-06651600 Maintenance Dose #2; Oral tablets taken QD
Experimental: Sequence E; Maintenance dose #3 given QD for 48 weeks	Drug: PF-06651600 Maintenance Dose #3; Oral tablets taken QD
Experimental: Sequence F; Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks	Drug: PF-06651600 Induction Dose; Oral tablets taken once daily (QD); Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD; Drug: Placebo; Oral tablets taken QD
Experimental: Sequence G; Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks	Drug: PF-06651600 Maintenance Dose #1; Oral tablets taken QD; Drug: Placebo; Oral tablets taken QD

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 [ Time Frame: 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 :

1. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 [ Time Frame: 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 <= 10 at week 24 were reported.
2. Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 [ Time Frame: 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 <= 10 at week 24 were reported.
3. Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 [ Time Frame: 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.
4. 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 [ Time Frame: Week 24 ]
   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.
5. 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 [ Time Frame: Week 24 ]
   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.
6. 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 [ Time Frame: 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.
7. 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 [ Time Frame: 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.
8. 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 [ Time Frame: 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.
9. Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 [ Time Frame: Baseline (Day 1), 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.
10. Change From Baseline in SALT Score at Week 28, 34, 40, and 48 [ Time Frame: Baseline (Day 1), 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.
11. 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 [ Time Frame: 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.
12. 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 [ Time Frame: 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.
13. 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 [ Time Frame: 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.
14. 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 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, 18, and 24 ]
    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.
15. Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations [ Time Frame: Baseline (Day 1), Week 34, 40, and 48 ]
    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.
16. 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 [ Time Frame: 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.

Other Outcome Measures:

1. Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, and 24 ]
   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.
2. Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 [ Time Frame: Baseline (Day 1), Week 48 ]
   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.
3. Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, and 24 ]
   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.
4. Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 [ Time Frame: Baseline (Day 1), Week 48 ]
   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.
5. 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 [ Time Frame: Week 4, 8, 12, 24 and 48 ]
   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.
6. 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 [ Time Frame: Week 4, 8, 12, 24 and 48 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

The University of Alabama at Birmingham Hospital Outreach Lab

Birmingham, Alabama, United States, 35233

The University of Alabama at Birmingham, Department of Dermatology

Birmingham, Alabama, United States, 35233

The University of Alabama at Birmingham, Department of Dermatology

Birmingham, Alabama, United States, 35294

United States, California

Mosaic Dermatology

Beverly Hills, California, United States, 90211

University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center

Irvine, California, United States, 92697

Dermatology Specialists, Inc.

Murrieta, California, United States, 92562

University of California, San Francisco

San Francisco, California, United States, 94115

Kaiser Permanente Clinical Trials Unit

San Francisco, California, United States, 94118

Southern California Dermatology, Inc.

Santa Ana, California, United States, 92701

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

University of Colorado Hospital Clinical and Translational Research Center

Aurora, Colorado, United States, 80045

University of Colorado Hospital Outpatient Pavillion

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale School of Medicine

New Haven, Connecticut, United States, 06510

Church Street Research Unit

New Haven, Connecticut, United States, 06519

United States, District of Columbia

Medstar Georgetown University Hospital Center-Department of Otolaryngology

Washington, District of Columbia, United States, 20007

Medstar Washington Hospital Center-Claude Nogay Research Pharmacy

Washington, District of Columbia, United States, 20010

Medstar Washington Hospital Center

Washington, District of Columbia, United States, 20010

Medstar Georgetown University Hospital Center-Department of Pediatrics

Washington, District of Columbia, United States, 20016

United States, Florida

Siperstein Dermatology Group

Boynton Beach, Florida, United States, 33472

Park Avenue Dermatology

Orange Park, Florida, United States, 32073

ForCare Clinical Research

Tampa, Florida, United States, 33613

United States, Idaho

Advanced Clinical Research

Meridian, Idaho, United States, 83642

United States, Illinois

Northwestern Medical Group

Chicago, Illinois, United States, 60611

Northwestern Medicine Diagnostic Testing Center

Chicago, Illinois, United States, 60611

Northwestern Medicine

Chicago, Illinois, United States, 60611

Northwestern Memorial Hospital, Investigational Research Pharmacy

Chicago, Illinois, United States, 60611

Northwestern University

Chicago, Illinois, United States, 60611

NorthShore University HealthSystem

Skokie, Illinois, United States, 60077

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

United States, Indiana

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

United States, Iowa

University of Iowa Hospitals and Clinics; Department of Pharmacy-IDS

Iowa City, Iowa, United States, 52242

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

United States, Maryland

Medstar Georgetown University Hospital - Department of Dermatology

Chevy Chase, Maryland, United States, 20815

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Minnesota

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, United States, 55455

University of Minnesota Medical Center, Investigational Drug Services Attn: Darlette Luke

Minneapolis, Minnesota, United States, 55455

United States, Nebraska

Skin Specialists, PC

Omaha, Nebraska, United States, 68144

United States, New Jersey

The Dermatology Group, P.C.

Verona, New Jersey, United States, 07044

United States, New York

NYU School of Medicine, The Ronald O. Perelman Department of Dermatology

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

United States, North Carolina

UNC CTRC

Chapel Hill, North Carolina, United States, 27514

UNC Hospitals, Investigational Drug Service

Chapel Hill, North Carolina, United States, 27514

UNC Dermatology Clinical Trials Unit

Chapel Hill, North Carolina, United States, 27516

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Oklahoma

Vital Prospects Clinical Research Institute, P.C

Tulsa, Oklahoma, United States, 74136

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Argentina

CINME Centro de Investigaciones Metabolicas

Caba, Buenos Aires, Argentina, C1027AAP

Psoriahue Medicina Interdisciplinaria

Caba, Argentina, C1425DKG

Australia, New South Wales

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia, 2217

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, Australia, 2217

Australia, Queensland

The Skin Centre

Benowa, Queensland, Australia, 4217

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Skin Health Institute

Carlton, Victoria, Australia, 3053

Sinclair Dermatology

East Melbourne, Victoria, Australia, 3002

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Royal Park Campus

Parkville, Victoria, Australia, 3052

Canada, Manitoba

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada, R3M 3Z4

Canada, Nova Scotia

Eastern Canada Cutaneous Research Associates Ltd.

Halifax, Nova Scotia, Canada, B3H 1Z2

Canada, Ontario

Guenther Research Inc

London, Ontario, Canada, N6A 3H7

Lynderm Research Inc.

Markham, Ontario, Canada, L3P 1X3

The Centre for Clinical Trials

Oakville, Ontario, Canada, L6J 7W5

SKiN Centre for Dermatology

Peterborough, Ontario, Canada, K9J 5K2

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada, L4C 9M7

Medicor Research Inc

Sudbury, Ontario, Canada, P3A1W8

Sudbury Skin Clinique

Sudbury, Ontario, Canada, P3C 1X8

Research Toronto

Toronto, Ontario, Canada, M4W 2N4

Canada, Quebec

Innovaderm Research Inc.

Montreal, Quebec, Canada, H2X 2V1

Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Quebec, Canada, G1V 4X7

Chile

Centro Internacional de Estudios Clinicos, CIEC

Santiago, Recoleta, Chile, 8420383

Centro Medico Skin Med

Santiago, Región Metropolitana, Chile, 7580206

Clinica Dermacross S.A.

Santiago, Región Metropolitana, Chile, 7640881

Medical Skin Center

Vina del Mar, Valparaiso, Chile, 2530900

China, Beijing

Peking University First Hospital

Beijing, Beijing, China, 100034

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing, China, 100050

Peking University Third Hospital

Beijing, Beijing, China, 100191

China, Guangdong

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China, 518053

China, Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

China, Jiangsu

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210029

China, Shanghai

Huashan Hospital, Fudan University/Dermatology Department

Shanghai, Shanghai, China, 200040

China, Zhejiang

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310003

The Second Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology Dept

Hangzhou, Zhejiang, China, 310009

China

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China, 200025

Colombia

Fundacion Centro de Investigacion Clinica CIC

Medellin, Antioquia, Colombia, 050001

Fundacion Hospitalaria San Vicente de Paul

Medellin, Antioquia, Colombia, 050010

Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS

Bogota, D.c., Colombia, 110221

Czechia

DERMAMEDICA s.r.o.

Nachod, Czechia, 54701

Fakultni nemocnice Olomouc

Olomouc, Czechia, 779 00

Clintrial s.r.o.

Praha 10, Czechia, 100 00

Sanatorium profesora Arenbergera

Praha 1, Czechia, 11000

Nemocnice Na Bulovce

Praha 8- Liben, Czechia, 180 81

Germany

Fachklinik Bad Bentheim

Bad Bentheim, Germany, 48455

Emovis GmbH

Berlin, Germany, 10629

Universitaetsklinikum Erlangen

Erlangen, Germany, 91054

University Hospital Frankfurt

Frankfurt am Main, Germany, 60590

University Hospital Schleswig-Holstein

Luebeck, Germany, 23538

University Hospital Muenster

Muenster, Germany, 48149

Hungary

Semmelweis Egyetem

Budapest, Hungary, 1085

Debreceni Egyetem

Debrecen, Hungary, 4032

Bugat Pal Korhaz, Borgyogyaszat

Gyongyos, Hungary, 3200

Szegedi Tudományegyetem Altalanos Orvostudomanyi Kar

Szeged, Hungary, 6720

Japan

Nagoya City University Hospital - Dermatology

Nagoya, Aichi, Japan, 467-8602

Tohoku University hospital

Sendai, Miyagi, Japan, 980-8574

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan, 431-3192

Juntendo Tokyo Koto Geriatric Medical Center

Koto-ku, Tokyo, Japan, 136-0075

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan, 160-0023

Osaka City University Hospital

Osaka, Japan, 545-8586

Korea, Republic of

Pusan National University Hospital

Busan, Korea, Republic of, 49241

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Mexico

Sociedad de Metabolismo y Corazon S.C.

Veracruz, Mexico, C.P. 91900

Hospital D'Maria

Veracruz, Mexico, CP. 91910

Poland

Centermed Krakow Sp.z o.o.

Krakow, Poland, 31-530

Medicover Sp.z.o.o

Lodz, Poland, 90-368

Dermoklinika Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Poland, 90-436

Sanova Audiological Care Polska Sp.z.o.o

Lodz, Poland, 91-867

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

RCMed Oddzial Warszawa

Warszawa, Poland, 02-657

Royalderm Agnieszka Nawrocka

Warszawa, Poland, 02-962

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Poland, 50-566

Russian Federation

State Budgetary Healthcare Institution Chelyabinsk Regional Clinical Dermatovenerologic Dispensary

Chelyabinsk, Russian Federation, 454092

University Clinic of Kirov SMU

Kirov, Russian Federation, 610035

Clinical Medical Center of A.I. Yevdokimov MSMSU

Moscow, Russian Federation, 111398

Federal State Autonomous Institution National Medical Research Centre of Childrens Health

Moscow, Russian Federation, 119991

State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"

Rostov-on-Don, Russian Federation, 344002

Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"

Saint Petersburg,, Russian Federation, 191123

Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)

Saint Petersburg, Russian Federation, 191123

Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -

Saint Petersburg, Russian Federation, 194021

State Autonomous Healthcare Institution of the Yaroslavl Region Clinical Emergency Hospital

Yaroslavl, Russian Federation, 150003

Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Hospital del Mar

Barcelona, Spain, 08003

Hospital Universitario Reina Sofía, Servicio Dermatologia

Cordoba, Spain, 14004

Servicio Otorrinolaringologia, Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

Servicio Radiologia, Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

Hospital Universitario Infanta Leonor

Madrid, Spain, 28031

Hospital Universitario La Paz

Madrid, Spain, 28046

Servicio de Dermatologia, Hospital Universitario y Politecnico La Fe

Valencia, Spain, 46026

Servicio de Otorrinolaringologia, Hospital Universitario y Politecnico La Fe

Valencia, Spain, 46026

Servicio de Radiologia, Hospital Universitario y Politecnico Le Fe

Valencia, Spain, 46026

Taiwan

CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch

Kaohsiung City, Taiwan, 83301

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, Taiwan, 23561

Chung Shan Medical University Hospital

Taichung, Taiwan, 40201

Chung-Shan Medical University Hospital

Taichung, Taiwan, 40201

National Taiwan University Hospital

Taipei, Taiwan, 100

Chang Gung Memorial Hospital-Linkou Branch

Taoyuan City, Taiwan, 333

United Kingdom

Brighton and Sussex University Hospitals NHS Trust

Brighton, EAST Sussex, United Kingdom, BN2 5BE

Southampton University Hospital NHS Foundation Trust, Royal South Hants Hospital

Southampton, Hampshire, United Kingdom, SO14 0YG

Brighton and Sussex University Hospitals NHS Trust

Brighton, United Kingdom, BN2 5BE

NHS Tayside Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

NHS Greater Glasgow and Clyde Queen Elizabeth University Hospital

Glasgow, United Kingdom, G51 4TF

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, G51 4TF

Southampton University Hospital NHS Foundation Trust, University Hospital Southampton

Hampshire, United Kingdom, SO16 6YD

Guy's and St.Thomas' Hospitals NHS Foundation Trust, St.Thomas' Hospital,

London,, United Kingdom, SE1 7EH

Guy's and St.Thomas' Hospitals NHS Foundation Trust, Guy's Hospital,

London,, United Kingdom, SE1 9RT

Harley Grove Medical Centre

London, United Kingdom, E3 2AT

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] April 14, 2021

Statistical Analysis Plan  [PDF] April 23, 2021

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03732807
• Other Study ID Numbers: B7981015; 2018-001714-14 ( EudraCT Number ); ALLEGRO 2B/3 ( Other Identifier: Alias Study Number )
• First Posted: November 7, 2018
• Results First Posted: February 24, 2022
• Last Update Posted: February 24, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Alopecia; Alopecia totalis; Alopecia universalis; Patchy hair loss; Diffuse hair loss; Hair loss; Hair disease; PF-06651600; Ritlecitinib

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical