Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Caba
Country [23] 0 0
Canada
State/province [23] 0 0
Manitoba
Country [24] 0 0
Canada
State/province [24] 0 0
Nova Scotia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Chile
State/province [27] 0 0
Recoleta
Country [28] 0 0
Chile
State/province [28] 0 0
Región Metropolitana
Country [29] 0 0
Chile
State/province [29] 0 0
Valparaiso
Country [30] 0 0
China
State/province [30] 0 0
Beijing
Country [31] 0 0
China
State/province [31] 0 0
Guangdong
Country [32] 0 0
China
State/province [32] 0 0
Hubei
Country [33] 0 0
China
State/province [33] 0 0
Jiangsu
Country [34] 0 0
China
State/province [34] 0 0
Shanghai
Country [35] 0 0
China
State/province [35] 0 0
Zhejiang
Country [36] 0 0
Colombia
State/province [36] 0 0
Antioquia
Country [37] 0 0
Colombia
State/province [37] 0 0
D.c.
Country [38] 0 0
Czechia
State/province [38] 0 0
Nachod
Country [39] 0 0
Czechia
State/province [39] 0 0
Olomouc
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 10
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 1
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 8- Liben
Country [43] 0 0
Germany
State/province [43] 0 0
Bad Bentheim
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Erlangen
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt am Main
Country [47] 0 0
Germany
State/province [47] 0 0
Luebeck
Country [48] 0 0
Germany
State/province [48] 0 0
Muenster
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Debrecen
Country [51] 0 0
Hungary
State/province [51] 0 0
Gyongyos
Country [52] 0 0
Hungary
State/province [52] 0 0
Szeged
Country [53] 0 0
Japan
State/province [53] 0 0
Aichi
Country [54] 0 0
Japan
State/province [54] 0 0
Miyagi
Country [55] 0 0
Japan
State/province [55] 0 0
Shizuoka
Country [56] 0 0
Japan
State/province [56] 0 0
Tokyo
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Busan
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Mexico
State/province [60] 0 0
Veracruz
Country [61] 0 0
Poland
State/province [61] 0 0
Krakow
Country [62] 0 0
Poland
State/province [62] 0 0
Lodz
Country [63] 0 0
Poland
State/province [63] 0 0
Szczecin
Country [64] 0 0
Poland
State/province [64] 0 0
Warszawa
Country [65] 0 0
Poland
State/province [65] 0 0
Wroclaw
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Chelyabinsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Kirov
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Moscow
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Rostov-on-Don
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Saint Petersburg,
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saint Petersburg
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Yaroslavl
Country [73] 0 0
Spain
State/province [73] 0 0
Barcelona
Country [74] 0 0
Spain
State/province [74] 0 0
Cordoba
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid
Country [76] 0 0
Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
Taiwan
State/province [77] 0 0
Kaohsiung City
Country [78] 0 0
Taiwan
State/province [78] 0 0
Kaohsiung
Country [79] 0 0
Taiwan
State/province [79] 0 0
New Taipei City
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taichung
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taoyuan City
Country [83] 0 0
United Kingdom
State/province [83] 0 0
EAST Sussex
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Hampshire
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Brighton
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Dundee
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Glasgow
Country [88] 0 0
United Kingdom
State/province [88] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03732807