At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABROCITINIB 100 MG AND 200 MG TABLETS IN PARTICIPANTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS IN INDIA
In Brief
A Phase 3 clinical trial evaluating Abrocitinib 100 mg and Abrocitinib 200 mg for Atopic Dermatitis. Completed, enrolled 200 participants across 15 sites.
Detailed Summary
The purpose of this clinical trial is to learn about the safety and how well the study medicine (called Abrocitinib) works for the potential treatment of moderate to severe Atopic Dermatitis (AD) in India. AD, also known as atopic eczema, is a chronic, relapsing skin condition characterized by dry, itchy skin lesions which can affect any part of the body. Adult peoples who participate in this study will take either 100 mg or 200 mg of abrocitinib tablets by mouth for a duration of 12 weeks and adolescents will take for duration of 52 weeks. Knee Magnetic Resonance Imagine (MRI) will be done on adolescent peoples to determine bone safety findings. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and how well they work.
Study Details
Timeline
Interventions
Orally administered, abrocitinib 100 mg tablets QD
Orally administered, abrocitinib 200 mg tablets QD.