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PF-06651600

Phase 3

Alopecia Areata | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Apr 9, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,917
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04006457Long-Term PF-06651600 for the Treatment of Alopecia AreataPHASE3 COMPLETED 1,057Jul 18, 2019Feb 26, 2026Apr 9, 2026144 United States, Argentina +15
NCT03732807PF-06651600 for the Treatment of Alopecia AreataPHASE2 COMPLETED 718Dec 3, 2018Jun 24, 2021Feb 24, 2022155 United States, Argentina +16
NCT02974868Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia AreataPHASE2 COMPLETED 142Dec 15, 2016May 15, 2019May 26, 202055 United States, Australia +1
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Study Endpoints
Primary Endpoints
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit
From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent if the event had start date on or after the first dosing date of this study.

Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit
From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; other important medical events. AEs leading to discontinuation included participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study or that action taken with study treatment was drug withdrawn.

Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit
From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Vital signs including blood pressure included systolic blood pressure (SBP) \[Millimeters of mercury, mmHg\]) and diastolic blood pressure (DBP) and pulse rate \[beats per minute (bpm)\] were measured using an automated device in a sitting position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Criteria for vital sign abnormalities included: SBP\<90mmHg, DBP\<50 mmHg and pulse rate\<40mmHg.

Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit
From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)

Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (\<0.8\*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration \<0.8\*LLN or \>1.5\*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (\>1.2\*ULN), Prothrombin Time(\>1.1\*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5\*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (\>3.0\*ULN); Albumin, Urate (\<0.8\*LLN and \>1.2\*ULN; Urea Nitrogen,Creatinine Cholesterol \>1.3\*ULN; Cholesterol \<0.8\*LLN or \>1.2\*LLN, Triglycerides,Potassium,Calcium \< 0.9x LLN \& \> 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite \>=1; Leukocyte Erythrocytes, Leukocytes \>=20; Epithelial Cells\>=6, Hyaline Cast\>1; Bacteria\>20. Number of participants with any laboratory abnormality meeting specified criteria is included.

Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response
Month 1

Booster response to tetanus toxoid was defined as: \>=4-fold rise in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration at Month 1 if the pre-vaccination concentration was \<=2.7 International Units per milliliter (IU/mL); OR \>=2-fold rise in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination concentration was \>2.7 IU/mL. Two-sided 95% confidence interval (CI) was based on Clopper-Pearson exact method.

Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
Week 24

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.

Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Baseline, Week24

SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).

Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
Week 28 up to Week 52

An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.

Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
COE day 1 up to end of study

An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.

Number of Participants With Laboratory Abnormalities During SBE Period
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)

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.

Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
COE day 1 up to end of study

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect \& Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.

Secondary Endpoints
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until End of Study
From start of study intervention (Day 1) until end of study
Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until End of Study
From start of study intervention (Day 1) until end of study
Main Study: Number of Participants With Clinically Significant Abnormalities in Vital Signs Until End of Study
From start of study intervention (Day 1) until end of study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment sequence 1EXPERIMENTALParticipants 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.
Treatment sequence 2EXPERIMENTALParticipants 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.
Sequence AEXPERIMENTALInduction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
Sequence BEXPERIMENTALInduction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
Sequence CEXPERIMENTALMaintenance dose #1 given QD for 48 weeks
Sequence DEXPERIMENTALMaintenance dose #2 given QD for 48 weeks
Sequence EEXPERIMENTALMaintenance dose #3 given QD for 48 weeks
Sequence FEXPERIMENTALPlacebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
Sequence GEXPERIMENTALPlacebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
Cohort 1EXPERIMENTALPF-06651600
Cohort 2EXPERIMENTALPF-06700841
Cohort placeboPLACEBO_COMPARATORplacebo
Interventions
NameTypeDescription
PF-06651600DRUG50 mg oral tablets/capsules
Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccineBIOLOGICALSingle intramuscular injection administered to patients participating in the vaccine sub-study
Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccineBIOLOGICALSingle intramuscular injection administered to patients participating in the vaccine sub-study
PF-06651600 Induction DoseDRUGOral tablets taken once daily (QD)
PF-06651600 Maintenance Dose #1DRUGOral tablets taken QD
PF-06651600 Maintenance Dose #2DRUGOral tablets taken QD
PF-06651600 Maintenance Dose #3DRUGOral tablets taken QD
PlaceboDRUGOral tablets taken QD
PF-06700841DRUG60 mg QD during induction and 30 mg QD during maintenance
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites144

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...

Countries:United StatesArgentinaAustraliaCanadaChileChinaColombiaCzechiaGermanyJapanMexicoPolandRussiaSouth KoreaSpainTaiwanUnited KingdomHungary
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04006457TRIAL_REMOVED: changed
LOWMay 24, 2026NCT04006457studyFirstPostDate: changed