Trial · NCT04006457
Long-Term PF-06651600 for the Treatment of Alopecia Areata
NCT04006457, Phase 3, Completed, Pfizer; results first posted 2025-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term PF-06651600 for the Treatment of Alopecia Areata. Trials, record NCT04006457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04006457
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term PF-06651600 for the Treatment of Alopecia Areata
- NCT number
- NCT04006457
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,057 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Alopecia Areata
- Interventions
- PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
- First posted
- 2019-07-05
- Last updated
- 2026-04-09
- Results first posted
- 2025-08-14
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | Vital signs including blood pressure (systolic and diastolic blood pressure \[Millimeters of mercury, mmHg\]) 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. Clinically significant abnormalities will be determined by investigator. |
| Secondary | Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study | From start of study intervention (Day 1) until end of study | Following laboratory parameters were assessed: Hemoglobin, Hematocrit, Erythrocytes Erythrocyte (ery.) corpuscular volume, Ery. Mean Corpuscular hemoglobin concentration, Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils, Monocytes, Prothrombin Time, Bilirubin, Direct Bilirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase; Albumin, Urate; Urea Nitrogen, Creatinine, Cholesterol, Triglycerides, Potassium, Calcium, Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite, Leukocyte Erythrocytes, Leukocytes; Epithelial Cells, Hyaline Cast, Bacteria. Clinically significant abnormalities will be determined by investigator. |
| Secondary | Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | SALT is a quantitative assessment of AA severity based on the scalp terminal hair loss. A visual aid was utilized showing the division of the scalp hair into four quadrants (back, top of scalp, right side and left side), with each of the four quadrants given an accurate determination of the percentage of scalp surface area covered, representing 24%, 40%, 18%, and 18% of the total scalp surface area, respectively. Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas and ranged from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating less hair loss. The SALT overall score included any hair loss regardless of etiology (e.g., including scalp hair loss due to both androgenetic alopecia and AA). In this outcome measure, percentage of participants with SALT overall score \<= 10 were reported. 95% CI was calculated based on normal approximation. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | SAS was defined as all participants who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | SAS was defined as all participants who took at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | SAS was defined as all participants who took at least 1 dose of study intervention. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | SAS was defined as all participants who took at least 1 dose of study intervention. Here, the Overall number of participants analyzed signifies the total number of participants evaluable for laboratory abnormalities, i.e. the number with at least one observation of the given laboratory test while on study treatment or during lag time (35 days after the last dose). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response | Month 1 | Safety Analysis Set (SAS) was defined as all participants from this sub-study who received at least 1 vaccine (Tdap or meningococcal ACWY). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | 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 | |||
| SECONDARY | 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 | |||
| SECONDARY | 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 | |||
| SECONDARY | Main Study: Number of Participants With Clinically Significant Laboratory Abnormalities Until End of Study | From start of study intervention (Day 1) until end of study | |||
| SECONDARY | Main Study: Percentage of Participants Achieving Response Based on Severity of Alopecia Tool (SALT) Overall Score <=10 at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32 and 36 | Full Analysis Set (FAS) was defined as all participants regardless of whether they received study intervention. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points. | Percentage of participants | NUMBER |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group436
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 401 | Participants | ||
| Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 515 | Participants | ||
| Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | SAEs | 30 | Participants | |
| Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | SAEs | 42 | Participants | |
| Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | AEs Leading to Discontinuation | 36 | Participants | |
| Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | AEs Leading to Discontinuation | 46 | Participants | |
| Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | Diastolic blood pressure (mmHg): value <50 | 11 | Participants | |
| Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | Diastolic blood pressure (mmHg): value <50 | 15 | Participants | |
| Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | Diastolic blood pressure (mmHg): change >=20 increase | 39 | Participants | |
| Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | Diastolic blood pressure (mmHg): change >=20 increase | 70 | Participants |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study: Treatment Period 1 | STARTED | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 449 | |
| Main Study: Treatment Period 1 | STARTED | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 603 | |
| Main Study: Treatment Period 1 | STARTED | Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine | 0 | |
| Main Study: Treatment Period 1 | Treated | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 447 | |
| Main Study: Treatment Period 1 | Treated | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 603 | |
| Main Study: Treatment Period 1 | Treated | Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine | 0 | |
| Main Study: Treatment Period 1 | COMPLETED | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 289 | |
| Main Study: Treatment Period 1 | COMPLETED | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 332 | |
| Main Study: Treatment Period 1 | COMPLETED | Vaccine Sub-study: Tdap With or Without Meningococcal ACWY Vaccine | 0 | |
| Main Study: Treatment Period 1 | NOT COMPLETED | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 160 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events368
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | GASTROINTESTINAL DISORDERS | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 24 | 447 | |
| other | Diarrhoea | GASTROINTESTINAL DISORDERS | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 25 | 603 | |
| other | Diarrhoea | GASTROINTESTINAL DISORDERS | Vaccine Sub-study: Tdap Vaccination | 0 | 17 | |
| other | Diarrhoea | GASTROINTESTINAL DISORDERS | Vaccine Sub-study: Meningococcal ACWY Vaccination | 0 | 13 | |
| other | Gastrooesophageal reflux disease | GASTROINTESTINAL DISORDERS | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 0 | 447 | |
| other | Gastrooesophageal reflux disease | GASTROINTESTINAL DISORDERS | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 0 | 603 | |
| other | Gastrooesophageal reflux disease | GASTROINTESTINAL DISORDERS | Vaccine Sub-study: Tdap Vaccination | 1 | 17 | |
| other | Gastrooesophageal reflux disease | GASTROINTESTINAL DISORDERS | Vaccine Sub-study: Meningococcal ACWY Vaccination | 0 | 13 | |
| other | Nausea | GASTROINTESTINAL DISORDERS | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 27 | 447 | |
| other | Nausea | GASTROINTESTINAL DISORDERS | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 27 | 603 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 1 | 447 |
| Total, all-cause mortality | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 1 | 603 |
| Total, all-cause mortality | Vaccine Sub-study: Tdap Vaccination | 0 | 17 |
| Total, all-cause mortality | Vaccine Sub-study: Meningococcal ACWY Vaccination | 0 | 13 |
| Total, other adverse events | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 309 | 447 |
| Total, other adverse events | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 372 | 603 |
| Total, other adverse events | Vaccine Sub-study: Tdap Vaccination | 3 | 17 |
| Total, other adverse events | Vaccine Sub-study: Meningococcal ACWY Vaccination | 1 | 13 |
| Total, serious adverse events | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | 33 | 447 |
| Total, serious adverse events | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 43 | 603 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vaccine Sub-study: Tdap Vaccination vs Vaccine Sub-study: Meningococcal ACWY Vaccination: Vaccine Sub-study: Number of Participants With AEs Leading to Discontinuation | Trial comparisons |
| Vaccine Sub-study: Tdap Vaccination vs Vaccine Sub-study: Meningococcal ACWY Vaccination: Vaccine Sub-study: Number of Participants With AEs | Trial comparisons |
Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) vs Main Study: Ritlecitinib 50 mg QD (Roll-over Participants): Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit | Trial comparisons |
| Vaccine Sub-study: Tdap Vaccination vs Vaccine Sub-study: Meningococcal ACWY Vaccination: Vaccine Sub-study: Number of Participants With SAEs | Trial comparisons |
Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) vs Main Study: Ritlecitinib 50 mg QD (Roll-over Participants): Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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