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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02974868




Registration number
NCT02974868
Ethics application status
Date submitted
23/11/2016
Date registered
29/11/2016

Titles & IDs
Public title
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Scientific title
A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD
Secondary ID [1] 0 0
2016-004048-13
Secondary ID [2] 0 0
B7931005
Universal Trial Number (UTN)
Trial acronym
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: Drugs - PF-06700841
Treatment: Drugs - Placebo

Experimental: Cohort 1 - PF-06651600

Experimental: Cohort 2 - PF-06700841

Placebo comparator: Cohort placebo - placebo


Treatment: Drugs: PF-06651600
200 mg QD during induction and 50 mg QD during Maintenance

Treatment: Drugs: PF-06700841
60 mg QD during induction and 30 mg QD during maintenance

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Timepoint [1] 0 0
Baseline, Week24
Primary outcome [2] 0 0
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
Timepoint [2] 0 0
Week 28 up to Week 52
Primary outcome [3] 0 0
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
Timepoint [3] 0 0
COE day 1 up to end of study
Primary outcome [4] 0 0
Number of Participants With Laboratory Abnormalities During SBE Period
Timepoint [4] 0 0
Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment)
Primary outcome [5] 0 0
Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
Timepoint [5] 0 0
COE day 1 up to end of study
Secondary outcome [1] 0 0
Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving SALT 30 at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Timepoint [3] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [4] 0 0
Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Timepoint [4] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [5] 0 0
Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)
Timepoint [5] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [6] 0 0
Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)
Timepoint [6] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [7] 0 0
Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)
Timepoint [7] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [8] 0 0
Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)
Timepoint [8] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [9] 0 0
Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)
Timepoint [9] 0 0
Baseline, Weeks 2,4,6,8,12,16,20,24
Secondary outcome [10] 0 0
Number of Participants With the IGA Score Change (Treatment Period)
Timepoint [10] 0 0
baseline, Week 2,4,6,8,12,16,20,24
Secondary outcome [11] 0 0
Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period
Timepoint [11] 0 0
baseline up to Week 24
Secondary outcome [12] 0 0
Number of Participants With Laboratory Abnormalities During Treatment Period
Timepoint [12] 0 0
Baseline up to Week 24
Secondary outcome [13] 0 0
Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period)
Timepoint [13] 0 0
Week 24 up to Week 52
Secondary outcome [14] 0 0
Change From Baseline in SALT Across Time (SBE Period)
Timepoint [14] 0 0
Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Secondary outcome [15] 0 0
Percentage of Participants Achieving SALT 30 Across Time (SBE Period)
Timepoint [15] 0 0
Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Secondary outcome [16] 0 0
Percentage of Participants Achieving SALT 50 Across Time (SBE Period)
Timepoint [16] 0 0
Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Secondary outcome [17] 0 0
Percentage of Participants Achieving SALT 75 Across Time (SBE Period)
Timepoint [17] 0 0
Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Secondary outcome [18] 0 0
Percentage of Participants Achieving SALT 90 Across Time (SBE Period)
Timepoint [18] 0 0
Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Secondary outcome [19] 0 0
Percentage of Participants Achieving SALT 100 Across Time (SBE Period)
Timepoint [19] 0 0
Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)

Eligibility
Key inclusion criteria
* Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
* Must have moderate to severe alopecia areata:
Minimum age
18 Years
Maximum age
75 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)
* Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.

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
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
15/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2019
Sample size
Target
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Hearing Life - Hurstville
Recruitment hospital [2] 0 0
Dr. Glen and Partners Medical Imaging - Kogarah
Recruitment hospital [3] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [4] 0 0
St. George Hearing and Balance Clinic - Kogarah
Recruitment hospital [5] 0 0
The Skin Centre - Benowa
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
Skin & Cancer Foundation Inc. - Carlton
Recruitment hospital [8] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [9] 0 0
Bridge Road Imag ing - Richmond
Recruitment hospital [10] 0 0
Richmond Audiology - Richmond
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3121 - Richmond
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
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
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
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
Manitoba
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario

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/NCT02974868