Trial · NCT03732807
PF-06651600 for the Treatment of Alopecia Areata
NCT03732807, Phase 2, Phase 3, Completed, Pfizer; results first posted 2022-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PF-06651600 for the Treatment of Alopecia Areata. Trials, record NCT03732807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03732807
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PF-06651600 for the Treatment of Alopecia Areata
- NCT number
- NCT03732807
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 718 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Alopecia Areata
- Interventions
- PF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1, PF-06651600 Maintenance Dose #2, PF-06651600 Maintenance Dose #3, Placebo
- First posted
- 2018-11-07
- Last updated
- 2022-02-24
- Other registries' IDs
- eudract:2018-001714-14
- Results first posted
- 2022-02-24
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | 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 \<= 10 at week 24 were reported. |
| Secondary | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 | 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 \<= 10 at week 24 were reported. |
| Secondary | Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 | Week 24 | 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. |
| Secondary | 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 | Week 24 | 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. |
| Secondary | 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 | Week 24 | 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. |
| Secondary | 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 | Week 4, 8, 12, 18, 28, 34, 40, and 48 | 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. |
| Secondary | 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 | Week 4, 8, 12, 18, 28, 34, 40, and 48 | 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. |
| Secondary | 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 | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | 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. |
| Secondary | Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 | Baseline (Day 1), Week 4, 8, 12, 18, and 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. Baseline was defined as pre-dose on Day 1. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Week 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Participants with missing SALT scores due to coronavirus disease-19 related reasons were excluded from this analysis, while participants with missing data due to other reasons were considered as non-responders. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | Week 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 4: Data imputed by using a missing at random (MAR) mechanism for participants with missing data due to COVID-19. Missing data due to reasons not related to COVID-19 were consider as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 | Week 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Analysis 1: Participants with missing SALT score at Week 24 due to COVID-19 related reasons excluded from analysis at that time point, participants with missing SALT scores due to other reasons counted as non-responders at that time point. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 | Week 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Week 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Week 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Week 4, 8, 12, 18, 28, 34, 40, and 48 | FAS included all participants who were randomized, regardless of whether they received study medication. Here, number analyzed signifies participants evaluable at specific time point. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Week 4, 8, 12, 18, 28, 34, 40, and 48 | FAS included all participants who were randomized, regardless of whether they received study medication. Here, number analyzed signifies participants evaluable at specific time point. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 | FAS included all participants who were randomized, regardless of whether they received study medication. Here, number analyzed signifies participants evaluable at specific time point. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 | Baseline (Day 1), Week 4, 8, 12, 18, and 24 | FAS included all participants who were randomized, regardless of whether they received study medication. Here, number analyzed signifies participants evaluable at specific time point. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group986
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 30.65 | 95% Confidence Interval 22.53 to 38.76 | Percentage of participants | |
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 22.31 | 95% Confidence Interval 14.90 to 29.73 | Percentage of participants | |
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Ritlecitinib (PF-06651600) 50 mg | 23.39 | 95% Confidence Interval 15.94 to 30.84 | Percentage of participants | |
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Ritlecitinib (PF-06651600) 30 mg | 14.29 | 95% Confidence Interval 8.00 to 20.57 | Percentage of participants | |
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Ritlecitinib (PF-06651600) 10 mg | 1.69 | 95% Confidence Interval 0.00 to 4.99 | Percentage of participants | |
| Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 | Placebo | 1.54 | 95% Confidence Interval 0.00 to 3.65 | Percentage of participants | |
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 21.29 | Percentage of participants | ||
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 12.87 | Percentage of participants | ||
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | Ritlecitinib (PF-06651600) 50 mg | 13.42 | Percentage of participants | ||
| Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 | Ritlecitinib (PF-06651600) 30 mg | 10.62 | Percentage of participants |
1 to 10 of 986Source ClinicalTrials.gov
See all 986 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (up to Week 24) | STARTED | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 132 | |
| Treatment Period (up to Week 24) | STARTED | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 130 | |
| Treatment Period (up to Week 24) | STARTED | Ritlecitinib (PF-06651600) 50 mg | 130 | |
| Treatment Period (up to Week 24) | STARTED | Ritlecitinib (PF-06651600) 30 mg | 132 | |
| Treatment Period (up to Week 24) | STARTED | Ritlecitinib (PF-06651600) 10 mg | 63 | |
| Treatment Period (up to Week 24) | STARTED | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 65 | |
| Treatment Period (up to Week 24) | STARTED | Placebo, Ritlecitinib (PF-06651600) 50 mg | 66 | |
| Treatment Period (up to Week 24) | COMPLETED | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 122 | |
| Treatment Period (up to Week 24) | COMPLETED | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 124 | |
| Treatment Period (up to Week 24) | COMPLETED | Ritlecitinib (PF-06651600) 50 mg | 121 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events252
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 | Abdominal pain upper | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 1 | 131 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 5 | 129 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 50 mg | 5 | 130 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 30 mg | 3 | 132 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 10 mg | 0 | 62 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 4 | 65 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo, Ritlecitinib (PF-06651600) 50 mg | 0 | 66 | |
| other | Constipation | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 1 | 131 | |
| other | Constipation | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 0 | 129 | |
| other | Constipation | Gastrointestinal disorders | Ritlecitinib (PF-06651600) 50 mg | 1 | 130 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 0 | 131 |
| Total, all-cause mortality | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 0 | 129 |
| Total, all-cause mortality | Ritlecitinib (PF-06651600) 50 mg | 0 | 130 |
| Total, all-cause mortality | Ritlecitinib (PF-06651600) 30 mg | 0 | 132 |
| Total, all-cause mortality | Ritlecitinib (PF-06651600) 10 mg | 0 | 62 |
| Total, all-cause mortality | Placebo, Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 0 | 65 |
| Total, all-cause mortality | Placebo, Ritlecitinib (PF-06651600) 50 mg | 0 | 66 |
| Total, other adverse events | Ritlecitinib (PF-06651600) 200 mg Then 50 mg | 84 | 131 |
| Total, other adverse events | Ritlecitinib (PF-06651600) 200 mg Then 30 mg | 76 | 129 |
| Total, other adverse events | Ritlecitinib (PF-06651600) 50 mg | 81 | 130 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers14
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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