Trial · NCT04517864
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 36 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study | Approximately 16 months | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This Outcome Measures presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator. |
| Secondary | Number of Participants With Temporary Drug Discontinuation Due to AEs | Approximately 16 months | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Approximately 16 months | Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Approximately 16 months | Safety laboratory assessments included the categories of Hematology, Chemistry, Urinalysis and other tests. The clinical significance was determined by the investigator. |
| Secondary | Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9 | Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Secondary | Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E | Baseline, Month 3E, 6E, 9E, 12E and 15E (Month 3, 6, 9, 12 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase. | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. The overall SALT score included hair loss regardless of etiology (ie, scalp hair loss due to both non-AA and AA) and was collected at study visits. The Overall SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Secondary | Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9 | Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase) | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score in Placebo-Controlled Phase = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Secondary | Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E | Baseline, Month 3E, 6E, 9E, 12E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase) | SALT is a quantitative assessment of AA severity based on scalp terminal hair loss. AA-SALT is the amount of scalp hair loss due to AA. AA SALT score = overall SALT score - non-AA SALT score (The non-AA SALT score only took into account scalp hair loss other than that due to AA and was required to be assessed only at Month 9 \[or Month 6 for those who entered the Active Therapy Extension Phase at Month 6\] in Placebo-Controlled Phase). The AA-SALT Score ranged from 0 to 100%, with higher scores representing greater amount of hair loss. |
| Secondary | Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9 | Months 1, 3, 6 and 9 | The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, "Since the start of the study, my alopecia areata has: …". The participants selected one of seven responses ranging from "greatly improved" to "greatly worsened". This Outcome Measure presented the number of participants with PGI-C response which was defined as "greatly improved" or "moderately improved". Participants with missing PGI-C scores were considered as non-responders. |
| Secondary | Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E | Month 3E, 6E, 9E, 12E and 15E | The PGI-C asked the participants to evaluate the improvement or worsening of their AA as compared to the start of the study using a single item, "Since the start of the study, my alopecia areata has: …". The participants selected one of seven responses ranging from "greatly improved" to "greatly worsened". This Outcome Measure presented the number of participants with PGI-C response which was defined as "greatly improved" or "moderately improved". Participants with missing PGI-C scores were considered as non-responders. |
| Secondary | Number of Participants With TEAEs and TESAEs: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Seriousness of an AE was assessed under the criteria of SAE. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. |
| Secondary | Number of Participants Who Discontinued From Study Due to AEs: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. Relatedness to study treatment was determined by the investigator. |
| Secondary | Number of Participants Who Discontinued Study Drug Due to AE and Continued Study: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. This outcome measure presented the number of participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Relatedness to study treatment was determined by the investigator. |
| Secondary | Number of Participants With Temporary Drug Discontinuation Due to AEs: Extension Phase (TP3) | From first dose of treatment up to 28 days follow up after last dose of study treatment (Approximately 19 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with temporary drug discontinuation due to both all-causality and treatment-related AEs are presented below. Relatedness to study treatment was determined by the investigator. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs: Extension Phase (TP3) | From screening up to 28 days follow up after last dose of study treatment (maximum up to 19 months) | Oral, tympanic, or axillary temperature, pulse rate, respiratory rate, and blood pressure (BP) were assessed. BP and pulse measurements were assessed in a chair, back supported and arms bared (free of restrictions such as rolled-up sleeves, etc) and supported at heart level. Measurements were taken on the same arm at each visit (preferably non-dominant) with a completely automated device. Pulse rate was measured at approximately the same time as BP for a minimum of 30 seconds. BP and pulse measurements preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (eg, television, cell phones). Participants were refrained from smoking or ingesting caffeine during the 30 minutes preceding the measurements. The clinical significance was determined by the investigator. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values: Extension Phase (TP3) | From screening up to 28 days after last dose of study treatment (maximum up to 19 months) | Safety laboratory assessments included the categories of hematology, chemistry, urinalysis and other tests. The clinical significance was determined by the investigator. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04517864/registered?page=2