Trial · NCT02974868
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| SECONDARY | Percentage of Participants Achieving SALT 50 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 |
| SECONDARY | Percentage of Participants Achieving SALT 75 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 |
| SECONDARY | Percentage of Participants Achieving SALT 90 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 |
| SECONDARY | Percentage of Participants Achieving SALT 100 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 |
| SECONDARY | Number of Participants With the IGA Score Change (Treatment Period) | baseline, Week 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period | baseline up to Week 24 | All participants who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) in Treatment Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities During Treatment Period | Baseline up to Week 24 | 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 treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period) | Week 24 up to Week 52 | All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24). | Weeks | NUMBER |
| SECONDARY | Change From Baseline in SALT Across Time (SBE Period) | Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) | Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data. 6 groups of participants were each compared with initial 24-week treatment period placebo. | unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving SALT 30 Across Time (SBE Period) | Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment) | 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. | percent of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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