Trial · NCT02974868
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
NCT02974868, Phase 2, Completed, Pfizer; results first posted 2020-05-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata. Trials, record NCT02974868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02974868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
- NCT number
- NCT02974868
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Alopecia Areata
- Interventions
- PF-06651600, PF-06700841, Placebo
- First posted
- 2016-11-29
- Last updated
- 2020-05-26
- Other registries' IDs
- eudract:2016-004048-13
- Results first posted
- 2020-05-26
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants | Baseline, Week 24 | SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline. |
| Secondary | Percentage of Participants Achieving SALT 30 at Week 24 | Baseline, Week 24 | SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method. |
| Secondary | Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) | Baseline, Weeks 2,4,6,8,12,16,20,24 | SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively. |
| Secondary | Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) | Baseline, Weeks 2,4,6,8,12,16,20,24 | SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively. |
| Secondary | Percentage of Participants Achieving SALT 30 Across Time (Treatment Period) | Baseline, Weeks 2,4,6,8,12,16,20,24 | SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline, Week24 | Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data at Week 24 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants | Baseline, Week 24 | Number of Participants Analyzed: AT/AU participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received. Number Analyzed: Number of participants with observed data at Week 24. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period | Week 28 up to Week 52 | The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | The safety analysis set (SAS) was used. 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 skipped the withdrawal segment and entered the retreatment segment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period | COE day 1 up to end of study | All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in COE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving SALT 30 at Week 24 | Baseline, Week 24 | All participants in the Full analysis set (FAS) was used and have observed data at Week 24. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) | Baseline, Weeks 2,4,6,8,12,16,20,24 | Number of participants analyzed: All randomized participants assigned to the study treatment. Number analyzed : Number of participants with observed data for each specified time point. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period) | Baseline, Weeks 2,4,6,8,12,16,20,24 | Number of participants analyzed: All randomized participants assigned to the study treatment. Number analyzed : Number of participants with observed data for each specified time point. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving SALT 30 Across Time (Treatment Period) | Baseline, Weeks 2,4,6,8,12,16,20,24 | All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received. | percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group711
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | PF-06651600 | 32.54 | 90% Confidence Interval 25.35 to 39.74 | units on a scale | |
| Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | PF-06700841 | 50.59 | 90% Confidence Interval 43.15 to 58.02 | units on a scale | |
| Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | Placebo | 1.41 | 90% Confidence Interval -6.03 to 8.85 | units on a scale | |
| Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants | PF-06651600-AT/AU | 27.59 | 90% Confidence Interval 15.24 to 39.94 | units on a scale | |
| Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants | PF-06700841-AT/AU | 48.42 | 90% Confidence Interval 36.38 to 60.47 | units on a scale | |
| Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants | Placebo-AT/AU | 1.81 | 90% Confidence Interval -11.00 to 14.63 | units on a scale | |
| Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period | Active Non-responders on PF-06651600 | TEAE (All Causalities) | 8 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period | Placebo Non-responders on PF-06651600 | TEAE (All Causalities) | 12 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period | Active Non-responders on PF-06700841 | TEAE (All Causalities) | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period | Placebo Non-responders on PF-06700841 | TEAE (All Causalities) | 10 | Participants |
1 to 10 of 711Source ClinicalTrials.gov
See all 711 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial 24-Week Treatment Period (TP) | STARTED | Placebo for PF-06651600 | 24 | |
| Initial 24-Week Treatment Period (TP) | STARTED | Placebo for PF-06700841 | 23 | |
| Initial 24-Week Treatment Period (TP) | STARTED | PF-06651600 | 48 | |
| Initial 24-Week Treatment Period (TP) | STARTED | PF-06700841 | 47 | |
| Initial 24-Week Treatment Period (TP) | COMPLETED | Placebo for PF-06651600 | 20 | |
| Initial 24-Week Treatment Period (TP) | COMPLETED | Placebo for PF-06700841 | 14 | |
| Initial 24-Week Treatment Period (TP) | COMPLETED | PF-06651600 | 45 | |
| Initial 24-Week Treatment Period (TP) | COMPLETED | PF-06700841 | 35 | |
| Initial 24-Week Treatment Period (TP) | NOT COMPLETED | Placebo for PF-06651600 | 4 | |
| Initial 24-Week Treatment Period (TP) | NOT COMPLETED | Placebo for PF-06700841 | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,605
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 | Acne | Skin and subcutaneous tissue disorders | Treatment Period-Placebo | 2 | 47 | |
| other | Acne | Skin and subcutaneous tissue disorders | Treatment Period-PF-06651600 | 5 | 48 | |
| other | Acne | Skin and subcutaneous tissue disorders | Treatment Period-PF-06700841 | 5 | 47 | |
| other | Acne | Skin and subcutaneous tissue disorders | Single Blind Extension-Active Non-responders on PF-06651600 | 0 | 16 | |
| other | Acne | Skin and subcutaneous tissue disorders | Single Blind Extension-Placebo Non-responders on PF-06651600 | 0 | 17 | |
| other | Acne | Skin and subcutaneous tissue disorders | Single Blind Extension-Active Non-responders on PF-06700841 | 0 | 5 | |
| other | Acne | Skin and subcutaneous tissue disorders | Single Blind Extension-Placebo Non-responders on PF-06700841 | 1 | 12 | |
| other | Acne | Skin and subcutaneous tissue disorders | SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment | 0 | 8 | |
| other | Acne | Skin and subcutaneous tissue disorders | SBE-Retreated PF-06651600 Responders in Withdrawal Segment | 0 | 14 | |
| other | Acne | Skin and subcutaneous tissue disorders | SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) | 0 | 9 |
1 to 10 of 1,605Source ClinicalTrials.gov
See all 1,605 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Period-Placebo | 0 | 47 |
| Total, all-cause mortality | Treatment Period-PF-06651600 | 0 | 48 |
| Total, all-cause mortality | Treatment Period-PF-06700841 | 0 | 47 |
| Total, all-cause mortality | Single Blind Extension-Active Non-responders on PF-06651600 | 0 | 16 |
| Total, all-cause mortality | Single Blind Extension-Placebo Non-responders on PF-06651600 | 0 | 17 |
| Total, all-cause mortality | Single Blind Extension-Active Non-responders on PF-06700841 | 0 | 5 |
| Total, all-cause mortality | Single Blind Extension-Placebo Non-responders on PF-06700841 | 0 | 12 |
| Total, all-cause mortality | SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment | 0 | 8 |
| Total, all-cause mortality | SBE-Retreated PF-06651600 Responders in Withdrawal Segment | 0 | 14 |
| Total, all-cause mortality | SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) | 0 | 9 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers9
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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