Alopecia areata
Conditions
Brief summary
Through the time the last participant completes the Follow-up visit or 28 days after the Month 36 visit: 1) Incidence of treatment emergent adverse events (TEAEs); 2) Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation; 3) Incidence of clinically significant abnormalities in vital signs; 4) Incidence of clinically significant abnormalities in clinical laboratory values.
Detailed description
•Incidence of TEAEs; •Incidence of SAEs and AEs leading to discontinuation; •Incidence of clinically significant abnormalities in vital signs; •Incidence of clinically significant abnormalities in clinical laboratory values. •Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 through month 36, for overall and AA SALT score;
Interventions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Through the time the last participant completes the Follow-up visit or 28 days after the Month 36 visit: 1) Incidence of treatment emergent adverse events (TEAEs); 2) Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation; 3) Incidence of clinically significant abnormalities in vital signs; 4) Incidence of clinically significant abnormalities in clinical laboratory values. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Incidence of TEAEs; •Incidence of SAEs and AEs leading to discontinuation; •Incidence of clinically significant abnormalities in vital signs; •Incidence of clinically significant abnormalities in clinical laboratory values. •Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 through month 36, for overall and AA SALT score; | — |
Countries
Czechia, Germany, Poland, Spain
Outcome results
None listed