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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04006457




Registration number
NCT04006457
Ethics application status
Date submitted
1/07/2019
Date registered
5/07/2019

Titles & IDs
Public title
Long-Term PF-06651600 for the Treatment of Alopecia Areata
Scientific title
A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
Secondary ID [1] 0 0
2019-001084-71
Secondary ID [2] 0 0
B7981032
Universal Trial Number (UTN)
Trial acronym
ALLEGRO-LT
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
Treatment: Other - Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Treatment: Other - Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Experimental: Treatment sequence 1 - Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months.

Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.

Experimental: Treatment sequence 2 - Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months.

Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.


Treatment: Drugs: PF-06651600
50 mg oral tablets/capsules

Treatment: Other: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study

Treatment: Other: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects reporting treatment-emergent adverse events
Timepoint [1] 0 0
Baseline through Month 36
Primary outcome [2] 0 0
Number of subjects reporting serious adverse events
Timepoint [2] 0 0
Baseline through Month 36
Primary outcome [3] 0 0
Number of subjects reporting adverse events leading to discontinuation
Timepoint [3] 0 0
Baseline through Month 36
Primary outcome [4] 0 0
Number of subjects with clinically significant abnormalities in vital signs
Timepoint [4] 0 0
Baseline through Month 36
Primary outcome [5] 0 0
Number of subjects with clinically significant abnormalities in clinical laboratory values
Timepoint [5] 0 0
Baseline through Month 36
Primary outcome [6] 0 0
Vaccine sub-study: Percentage of subjects with a tetanus booster response
Timepoint [6] 0 0
Vaccine sub-study Month 1
Secondary outcome [1] 0 0
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10
Timepoint [1] 0 0
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary outcome [2] 0 0
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20
Timepoint [2] 0 0
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary outcome [3] 0 0
Change from baseline in SALT score
Timepoint [3] 0 0
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary outcome [4] 0 0
Percentage of subjects with a 75% improvement in SALT score from baseline
Timepoint [4] 0 0
Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
Secondary outcome [5] 0 0
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score
Timepoint [5] 0 0
Months 1, 3, 6, 12, 18, 24, and 36
Secondary outcome [6] 0 0
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score
Timepoint [6] 0 0
Months 1, 3, 6, 12, 18, 24, and 36
Secondary outcome [7] 0 0
Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved"
Timepoint [7] 0 0
Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary outcome [8] 0 0
Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains
Timepoint [8] 0 0
Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary outcome [9] 0 0
Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS)
Timepoint [9] 0 0
Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary outcome [10] 0 0
Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)
Timepoint [10] 0 0
Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary outcome [11] 0 0
Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of depression who achieved a "normal" subscale score indicative of an absence of depression
Timepoint [11] 0 0
Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary outcome [12] 0 0
Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of anxiety who achieved a "normal" subscale score indicative of an absence of anxiety
Timepoint [12] 0 0
Months 1, 3, 6, 9, 12, 18, 24, and 36
Secondary outcome [13] 0 0
Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response
Timepoint [13] 0 0
Vaccine sub-study Month 1
Secondary outcome [14] 0 0
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level =1.0 IU/mL
Timepoint [14] 0 0
Vaccine sub-study Month 1
Secondary outcome [15] 0 0
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level =0.1 IU/mL
Timepoint [15] 0 0
Vaccine sub-study Month 1
Secondary outcome [16] 0 0
Vaccine sub-study: Percentage of subjects with =4x increase in anti-tetanus antibody level from baseline
Timepoint [16] 0 0
Vaccine sub-study Month 1
Secondary outcome [17] 0 0
Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values
Timepoint [17] 0 0
Vaccine sub-study Month 1
Secondary outcome [18] 0 0
Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels
Timepoint [18] 0 0
Vaccine sub-study Month 1
Secondary outcome [19] 0 0
Vaccine sub-study: Percentage of subjects with =1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C
Timepoint [19] 0 0
Vaccine sub-study Month 1
Secondary outcome [20] 0 0
Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C
Timepoint [20] 0 0
Vaccine sub-study Day 1 and Month 1
Secondary outcome [21] 0 0
Number of subjects reporting treatment-emergent adverse events
Timepoint [21] 0 0
Month 37 through Month 60
Secondary outcome [22] 0 0
Number of subjects reporting serious adverse events
Timepoint [22] 0 0
Month 37 through Month 60
Secondary outcome [23] 0 0
Number of subjects reporting adverse events leading to discontinuation
Timepoint [23] 0 0
Month 37 through Month 60
Secondary outcome [24] 0 0
Number of subjects with clinically significant abnormalities in vital signs
Timepoint [24] 0 0
Month 37 through Month 60
Secondary outcome [25] 0 0
Number of subjects with clinically significant abnormalities in clinical laboratory values
Timepoint [25] 0 0
Month 37 through Month 60
Secondary outcome [26] 0 0
Vaccine sub-study: Number of subjects reporting serious adverse events
Timepoint [26] 0 0
Vaccine sub-study Month 1
Secondary outcome [27] 0 0
Vaccine sub-study: Number of subjects reporting adverse events
Timepoint [27] 0 0
Vaccine sub-study Month 1
Secondary outcome [28] 0 0
Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation
Timepoint [28] 0 0
Vaccine sub-study Month 1

Eligibility
Key inclusion criteria
Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

* Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
* De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
* De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
* No evidence of terminal scalp hair regrowth within 6 months (de novo only)
* Current episode of terminal scalp hair loss <=10 years (de novo only)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

* Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
* History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
* History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
* Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Exclusion criteria for all participants:

- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/01/2026
Actual
Sample size
Target
Accrual to date
Final
1051
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 & 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
Royal Melbourne Hospital, Melbourne Health - Parkville
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - 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
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Nebraska
Country [15] 0 0
United States of America
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New Jersey
Country [16] 0 0
United States of America
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New York
Country [17] 0 0
United States of America
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North Carolina
Country [18] 0 0
United States of America
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Ohio
Country [19] 0 0
United States of America
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Oklahoma
Country [20] 0 0
United States of America
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Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Chile
State/province [29] 0 0
LAS Condes
Country [30] 0 0
Chile
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Recoleta
Country [31] 0 0
Chile
State/province [31] 0 0
Valparaiso
Country [32] 0 0
Chile
State/province [32] 0 0
Vitacura
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Guangdong
Country [35] 0 0
China
State/province [35] 0 0
Hubei
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China
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Jiangsu
Country [37] 0 0
China
State/province [37] 0 0
Shanghai
Country [38] 0 0
China
State/province [38] 0 0
Zhejiang
Country [39] 0 0
Colombia
State/province [39] 0 0
Antioquia
Country [40] 0 0
Colombia
State/province [40] 0 0
Bogota D.C.
Country [41] 0 0
Czechia
State/province [41] 0 0
Nachod
Country [42] 0 0
Czechia
State/province [42] 0 0
Olomouc
Country [43] 0 0
Czechia
State/province [43] 0 0
Praha 10
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 1
Country [45] 0 0
Germany
State/province [45] 0 0
Lower Saxony
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Bentheim
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Erlangen
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Germany
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Frankfurt am Main
Country [50] 0 0
Germany
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Luebeck
Country [51] 0 0
Germany
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Muenster
Country [52] 0 0
Japan
State/province [52] 0 0
Aichi
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Japan
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Miyagi
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Japan
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Shizuoka
Country [55] 0 0
Japan
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Tokyo
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Japan
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Osaka
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Korea, Republic of
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Busan
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Korea, Republic of
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Seoul
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Mexico
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Veracruz
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Poland
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Zachodniopomorskie
Country [61] 0 0
Poland
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Grodzisk Mazowiecki
Country [62] 0 0
Poland
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Krakow
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Poland
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Lodz
Country [64] 0 0
Poland
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Ostrowiec Swietokrzyski
Country [65] 0 0
Poland
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Szczecin
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Poland
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Warszawa
Country [67] 0 0
Poland
State/province [67] 0 0
Wroclaw
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Chelyabinsk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Kirov
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Moscow
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Rostov-on-Don
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Saint Petersburg,
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Saint Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Yaroslavl
Country [75] 0 0
Spain
State/province [75] 0 0
Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
Cordoba
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Taiwan
State/province [79] 0 0
R.o.c.
Country [80] 0 0
Taiwan
State/province [80] 0 0
Kaohsiung City
Country [81] 0 0
Taiwan
State/province [81] 0 0
Kaohsiung
Country [82] 0 0
Taiwan
State/province [82] 0 0
New Taipei City
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taoyuan City
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Hampshire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Brighton
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Glasgow
Country [88] 0 0
United Kingdom
State/province [88] 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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04006457