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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03715829




Registration number
NCT03715829
Ethics application status
Date submitted
19/10/2018
Date registered
23/10/2018

Titles & IDs
Public title
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Scientific title
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO
Secondary ID [1] 0 0
2018-001271-20
Secondary ID [2] 0 0
B7981019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Non-segmental Vitiligo 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06651600
Treatment: Drugs - PF-06651600
Treatment: Drugs - PF-06651600
Treatment: Drugs - PF-06651600
Treatment: Drugs - PF-06651600
Treatment: Drugs - placebo
Treatment: Drugs - PF06700841
Treatment: Devices - narrow-band UVB phototherapy

Experimental: Cohort 1 - Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks

Experimental: Cohort 2 - Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks

Experimental: Cohort 3 - Maintenance dose A given QD for 24 weeks

Experimental: Cohort 4 - Maintenance dose B given QD for 24 weeks

Experimental: Cohort 5 - Maintenance dose C given QD for 24 weeks

Placebo comparator: Cohort 6 - Placebo given QD for 24 weeks

Experimental: Extension Cohort 1 - 4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks

Experimental: Extension Cohort 2 - Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks in conjunction with narrow band UVB phototherapy

Experimental: Extension Cohort 3 - Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks

Experimental: Extension Cohort 4 - Maintenance dose A given QD for 24 weeks

Experimental: Extension Cohort 5 - Maintenance dose B given QD for 24 weeks

No intervention: Extension Cohort 6 - Observation period for 24 weeks


Treatment: Drugs: PF-06651600
Induction dose 1. Oral tablet taken QD

Treatment: Drugs: PF-06651600
Induction dose 2. Oral tablet taken QD

Treatment: Drugs: PF-06651600
Maintenance dose A. Oral tablet taken QD

Treatment: Drugs: PF-06651600
Maintenance Dose B. Oral tablet taken QD

Treatment: Drugs: PF-06651600
Maintenance Dose C. Oral tablet taken QD

Treatment: Drugs: placebo
placebo

Treatment: Drugs: PF06700841
Oral tablet taken QD

Treatment: Devices: narrow-band UVB phototherapy
Phototherapy will be combined with PF-06651600
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
Timepoint [1] 0 0
Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
Timepoint [2] 0 0
24 weeks
Primary outcome [3] 0 0
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
Timepoint [3] 0 0
Baseline up to Week 24
Primary outcome [4] 0 0
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
Timepoint [4] 0 0
Baseline up to Week 24
Primary outcome [5] 0 0
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
Timepoint [5] 0 0
24 weeks
Primary outcome [6] 0 0
Number of Participants With TEAEs and SAEs - Extension (Ext) Period
Timepoint [6] 0 0
24 weeks
Primary outcome [7] 0 0
Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
Timepoint [7] 0 0
24 weeks
Primary outcome [8] 0 0
Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
Timepoint [8] 0 0
24 Weeks
Primary outcome [9] 0 0
Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
Timepoint [9] 0 0
24 weeks
Secondary outcome [1] 0 0
Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
Timepoint [3] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [4] 0 0
Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
Timepoint [4] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [5] 0 0
Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [6] 0 0
Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
Timepoint [6] 0 0
Baseline, Weeks 4, 16 and 24
Secondary outcome [7] 0 0
Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
Timepoint [7] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [8] 0 0
Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period
Timepoint [8] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [9] 0 0
Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period
Timepoint [9] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [10] 0 0
Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period
Timepoint [10] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [11] 0 0
Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period
Timepoint [11] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [12] 0 0
Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period
Timepoint [12] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [13] 0 0
Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period
Timepoint [13] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [14] 0 0
Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period
Timepoint [14] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [15] 0 0
Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period
Timepoint [15] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [16] 0 0
Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period
Timepoint [16] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [17] 0 0
Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period
Timepoint [17] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [18] 0 0
Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period
Timepoint [18] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [19] 0 0
Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period
Timepoint [19] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [20] 0 0
Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period
Timepoint [20] 0 0
Baseline, Weeks 4, 16 and 24
Secondary outcome [21] 0 0
Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
Timepoint [21] 0 0
Baseline, Weeks 4, 16 and 24
Secondary outcome [22] 0 0
Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
Timepoint [22] 0 0
Baseline, Weeks 4, 16 and 24
Secondary outcome [23] 0 0
Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
Timepoint [23] 0 0
Baseline, Weeks 4, 16 and 24
Secondary outcome [24] 0 0
Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
Timepoint [24] 0 0
Week 24

Eligibility
Key inclusion criteria
* Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.
* Must have moderate to severe active non-segmental vitiligo.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
* Infected with hepatitis B or hepatitis C viruses.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

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 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
26/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/02/2021
Sample size
Target
Accrual to date
Final
366
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The Skin Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [4] 0 0
Skin Health Institute - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussel
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Germany
State/province [23] 0 0
Bad Bentheim
Country [24] 0 0
Germany
State/province [24] 0 0
Erlangen
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt am Main
Country [26] 0 0
Germany
State/province [26] 0 0
Luebeck
Country [27] 0 0
Germany
State/province [27] 0 0
Mainz
Country [28] 0 0
Germany
State/province [28] 0 0
Muenster
Country [29] 0 0
Italy
State/province [29] 0 0
RM
Country [30] 0 0
Japan
State/province [30] 0 0
Aichi
Country [31] 0 0
Japan
State/province [31] 0 0
Miyagi
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Japan
State/province [33] 0 0
Yamanashi
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gyeonggi-do
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Incheon
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Cordoba
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Tainan
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei

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/NCT03715829