Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Query!
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
Query!
Secondary ID [1]
0
0
2018-001714-14
Query!
Secondary ID [2]
0
0
B7981015
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ALLEGRO-2b/3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (\<=) 20 at week 24 were reported.
Query!
Timepoint [1]
0
0
Week 24
Query!
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
Query!
Assessment method [1]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score \<= 10 at week 24 were reported.
Query!
Timepoint [1]
0
0
Week 24
Query!
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
Query!
Assessment method [2]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score \<= 10 at week 24 were reported.
Query!
Timepoint [2]
0
0
Week 24
Query!
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
Query!
Assessment method [3]
0
0
PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
Query!
Timepoint [3]
0
0
Week 24
Query!
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
Query!
Assessment method [4]
0
0
The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score \<=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT \<=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Query!
Timepoint [4]
0
0
Week 24
Query!
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
Query!
Assessment method [5]
0
0
The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score \<=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT \<=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Query!
Timepoint [5]
0
0
Week 24
Query!
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
Query!
Assessment method [6]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
Query!
Timepoint [6]
0
0
Week 4, 8, 12, 18, 28, 34, 40, and 48
Query!
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
Query!
Assessment method [7]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score \<=10 were reported.
Query!
Timepoint [7]
0
0
Week 4, 8, 12, 18, 28, 34, 40, and 48
Query!
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
Query!
Assessment method [8]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.
Query!
Timepoint [8]
0
0
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Query!
Secondary outcome [9]
0
0
Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24
Query!
Assessment method [9]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Query!
Timepoint [9]
0
0
Baseline (Day 1), Week 4, 8, 12, 18, and 24
Query!
Secondary outcome [10]
0
0
Change From Baseline in SALT Score at Week 28, 34, 40, and 48
Query!
Assessment method [10]
0
0
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
Query!
Timepoint [10]
0
0
Baseline (Day 1), Week 28, 34, 40, and 48
Query!
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
Query!
Assessment method [11]
0
0
EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.
Query!
Timepoint [11]
0
0
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Query!
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
Query!
Assessment method [12]
0
0
ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.
Query!
Timepoint [12]
0
0
Week 4, 8, 12, 18, 24, 28, 34, 40, and 48
Query!
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
Query!
Assessment method [13]
0
0
PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
Query!
Timepoint [13]
0
0
Week 4, 8, 12, 18, 24, 34, 40, and 48
Query!
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
Query!
Assessment method [14]
0
0
AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Query!
Timepoint [14]
0
0
Baseline (Day 1), Week 4, 8, 12, 18, and 24
Query!
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
Query!
Assessment method [15]
0
0
AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
Query!
Timepoint [15]
0
0
Baseline (Day 1), Week 34, 40, and 48
Query!
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
Query!
Assessment method [16]
0
0
AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.
Query!
Timepoint [16]
0
0
Week 4, 8, 12, 18, 24, 34, 40, and 48
Query!
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
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
24/06/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
718
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Premier Specialists Pty Ltd - Kogarah
Query!
Recruitment hospital [2]
0
0
St George Dermatology and Skin Cancer Centre - Kogarah
Query!
Recruitment hospital [3]
0
0
The Skin Centre - Benowa
Query!
Recruitment hospital [4]
0
0
Veracity Clinical Research Pty Ltd - Woolloongabba
Query!
Recruitment hospital [5]
0
0
Skin Health Institute - Carlton
Query!
Recruitment hospital [6]
0
0
Sinclair Dermatology - East Melbourne
Query!
Recruitment hospital [7]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment hospital [8]
0
0
Royal Park Campus - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [3]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [4]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [7]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nebraska
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Caba
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Manitoba
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Nova Scotia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Quebec
Query!
Country [27]
0
0
Chile
Query!
State/province [27]
0
0
Recoleta
Query!
Country [28]
0
0
Chile
Query!
State/province [28]
0
0
Región Metropolitana
Query!
Country [29]
0
0
Chile
Query!
State/province [29]
0
0
Valparaiso
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Beijing
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Guangdong
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Hubei
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Jiangsu
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Shanghai
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Zhejiang
Query!
Country [36]
0
0
Colombia
Query!
State/province [36]
0
0
Antioquia
Query!
Country [37]
0
0
Colombia
Query!
State/province [37]
0
0
D.c.
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Nachod
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Olomouc
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Praha 10
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Praha 1
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Praha 8- Liben
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Bad Bentheim
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Berlin
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Erlangen
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Frankfurt am Main
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Luebeck
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Muenster
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Budapest
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Debrecen
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Gyongyos
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Szeged
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Aichi
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Miyagi
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Shizuoka
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Tokyo
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Osaka
Query!
Country [58]
0
0
Korea, Republic of
Query!
State/province [58]
0
0
Busan
Query!
Country [59]
0
0
Korea, Republic of
Query!
State/province [59]
0
0
Seoul
Query!
Country [60]
0
0
Mexico
Query!
State/province [60]
0
0
Veracruz
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Krakow
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Lodz
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Szczecin
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Warszawa
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Wroclaw
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Chelyabinsk
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Kirov
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Moscow
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Rostov-on-Don
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Saint Petersburg,
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Saint Petersburg
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Yaroslavl
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Barcelona
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Cordoba
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Madrid
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Valencia
Query!
Country [77]
0
0
Taiwan
Query!
State/province [77]
0
0
Kaohsiung City
Query!
Country [78]
0
0
Taiwan
Query!
State/province [78]
0
0
Kaohsiung
Query!
Country [79]
0
0
Taiwan
Query!
State/province [79]
0
0
New Taipei City
Query!
Country [80]
0
0
Taiwan
Query!
State/province [80]
0
0
Taichung
Query!
Country [81]
0
0
Taiwan
Query!
State/province [81]
0
0
Taipei
Query!
Country [82]
0
0
Taiwan
Query!
State/province [82]
0
0
Taoyuan City
Query!
Country [83]
0
0
United Kingdom
Query!
State/province [83]
0
0
EAST Sussex
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Hampshire
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
Brighton
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Dundee
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Glasgow
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
London,
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03732807
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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.
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/07/NCT03732807/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/07/NCT03732807/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03732807