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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03732807
Ethics application status
Date submitted
5/11/2018
Date registered
7/11/2018
Date last updated
1/08/2019

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 subjects achieving an absolute Severity of Alopecia Tool (SALT) Score <=10 - Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Characterize exposure response on the percentage of subjects achieving an absolute SALT score <=10 - Exposure response will be characterized using a Bayesian three-parameter exposure response model.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of subjects achieving a SALT score of <=10 - Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Timepoint [2] 0 0
Weeks 4, 8, 12, 18, 28, 34, 40, and 48
Secondary outcome [3] 0 0
Percentage of subjects achieving a 50% improvement in SALT score from baseline - Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Timepoint [3] 0 0
Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [4] 0 0
Percentage of subjects achieving a 75% improvement in SALT score from baseline - Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Timepoint [4] 0 0
Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [5] 0 0
Percentage of subjects achieving a 90% improvement in SALT score from baseline - Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Timepoint [5] 0 0
Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [6] 0 0
Absolute SALT scores - Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Timepoint [6] 0 0
Baseline, Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [7] 0 0
Percentage of subjects achieving at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score - The eyebrow assessment (EBA) is an numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Timepoint [7] 0 0
Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [8] 0 0
Percentage of subjects achieving at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score - The eyelash assessment (ELA) is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Timepoint [8] 0 0
Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48
Secondary outcome [9] 0 0
Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) scale scores - The Alopecia Areata Patient Priority Outcomes (AAPPO) scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.
Timepoint [9] 0 0
Weeks 4, 8, 12, 18, 24, 34, 40, and 48
Secondary outcome [10] 0 0
Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS) - HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Timepoint [10] 0 0
Weeks 4, 8, 12, 24, and 48
Secondary outcome [11] 0 0
Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS) - HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Timepoint [11] 0 0
Weeks 4, 8, 12, 24, and 48
Secondary outcome [12] 0 0
Change from baseline in 36 Item Short Form Health Survey version 2 Acute (SF36v2 Acute) - 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS).
Timepoint [12] 0 0
Weeks 4, 8, 12, 24, 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
Gender
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/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 & Cancer Foundation Inc. - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [7] 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 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
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Japan
State/province [20] 0 0
Aichi
Country [21] 0 0
Japan
State/province [21] 0 0
Miyagi
Country [22] 0 0
Japan
State/province [22] 0 0
Shizuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Tokyo
Country [24] 0 0
Japan
State/province [24] 0 0
Osaka
Country [25] 0 0
Taiwan
State/province [25] 0 0
New Taipei City

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/show/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
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

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