A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.
ConditionSevere Alopecia Areata
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorPfizer
About this trial
The purpose of this observation study is to learn about the safety and effects of the study medicine (called Litfulo) for the potential treatment of Severe Alopecia Areata.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients with severe alopecia areata
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Litfulo
Drugas provided in real world practice.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Patients with severe alopecia areata.1 intervention
Trial outcomes
Primary outcomes
1
Frequency and proportion of AEs/ADRs
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)2
Frequency and proportion of unexpected AEs/ADRs
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)3
Frequency and proportion of SAEs/SADRs
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)4
Frequency and proportion of AESI
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)Secondary outcomes
1
Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)2
Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)3
Proportion of patients achieving 50% or above improvement in SALT score from baseline (SALT 50) at Weeks 24 and 48
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)4
Proportion of patients achieving 75% or above improvement in SALT score from baseline (SALT 75) at Weeks 24 and 48
Time frame
24 weeks (Regular surveillance), 48 weeks (Long-term surveillance) Source ClinicalTrials.gov