drugset / Trial / NCT05375929

A Study to Learn About Abrocitinib Tablets in People With Atopic Dermatitis in India

NCT05375929

Phase 3 Completed 200 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-16
Primary completion
2023-06-09
Completion
2024-03-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Abrocitinib Small molecule 100 mg Oral
Subject Abrocitinib Small molecule 200 mg Oral

Indications