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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03732807




Registration number
NCT03732807
Ethics application status
Date submitted
5/11/2018
Date registered
7/11/2018
Date last updated
24/02/2022

Titles & IDs
Public title
PF-06651600 for the Treatment of Alopecia Areata
Scientific 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
Secondary ID [1] 0 0
2018-001714-14
Secondary ID [2] 0 0
B7981015
Universal Trial Number (UTN)
Trial acronym
ALLEGRO-2b/3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06651600 Induction Dose
Treatment: Drugs - PF-06651600 Maintenance Dose #1
Treatment: Drugs - PF-06651600 Maintenance Dose #2
Treatment: Drugs - PF-06651600 Maintenance Dose #3
Treatment: Drugs - Placebo

Experimental: Sequence A - Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks

Experimental: Sequence B - Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks

Experimental: Sequence C - Maintenance dose #1 given QD for 48 weeks

Experimental: Sequence D - Maintenance dose #2 given QD for 48 weeks

Experimental: Sequence E - Maintenance dose #3 given QD for 48 weeks

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

Experimental: Sequence G - Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks


Treatment: Drugs: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)

Treatment: Drugs: PF-06651600 Maintenance Dose #1
Oral tablets taken QD

Treatment: Drugs: PF-06651600 Maintenance Dose #2
Oral tablets taken QD

Treatment: Drugs: PF-06651600 Maintenance Dose #3
Oral tablets taken QD

Treatment: Drugs: Placebo
Oral tablets taken QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Week 4, 8, 12, 18, 28, 34, 40, and 48
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Week 4, 8, 12, 18, 28, 34, 40, and 48
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [9] 0 0
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
Timepoint [9] 0 0
Baseline (Day 1), Week 4, 8, 12, 18, and 24
Secondary outcome [10] 0 0
Change From Baseline in SALT Score at Week 28, 34, 40, and 48
Timepoint [10] 0 0
Baseline (Day 1), Week 28, 34, 40, and 48
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Week 4, 8, 12, 18, 24, 34, 40, and 48
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline (Day 1), Week 4, 8, 12, 18, and 24
Secondary outcome [15] 0 0
Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations
Timepoint [15] 0 0
Baseline (Day 1), Week 34, 40, and 48
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Week 4, 8, 12, 18, 24, 34, 40, and 48

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/06/2021
Sample size
Target
Accrual to date
Final
718
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [3] 0 0
The Skin Centre - Benowa
Recruitment hospital [4] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [5] 0 0
Skin Health Institute - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Royal Park Campus - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
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District of Columbia
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United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
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Idaho
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Illinois
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Indiana
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Iowa
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Maryland
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Massachusetts
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Minnesota
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Nebraska
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New Jersey
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New York
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North Carolina
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Oklahoma
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Texas
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Argentina
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Buenos Aires
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Argentina
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Caba
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Canada
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Manitoba
Country [24] 0 0
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Nova Scotia
Country [25] 0 0
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Ontario
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Canada
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Quebec
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Chile
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Recoleta
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Chile
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Región Metropolitana
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Chile
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Valparaiso
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China
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Beijing
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China
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Guangdong
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China
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Hubei
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China
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Jiangsu
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China
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Shanghai
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China
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Zhejiang
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Colombia
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Antioquia
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Colombia
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D.c.
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Czechia
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Nachod
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Czechia
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Olomouc
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Czechia
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Praha 10
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Czechia
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Praha 1
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Czechia
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Praha 8- Liben
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Germany
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Bad Bentheim
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Frankfurt am Main
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Germany
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Luebeck
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Germany
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Muenster
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Budapest
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Hungary
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Debrecen
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Gyongyos
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Hungary
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Szeged
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Aichi
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Miyagi
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Tokyo
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Osaka
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Busan
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Lodz
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Wroclaw
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Kirov
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Moscow
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Rostov-on-Don
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Saint Petersburg,
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Saint Petersburg
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Yaroslavl
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Cordoba
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Madrid
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Spain
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Valencia
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
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EAST Sussex
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Hampshire
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Brighton
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Dundee
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Glasgow
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United Kingdom
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London,
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03732807
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03732807