NCT05375929

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Abrocitinib is an oral, once daily Janus kinase 1 (JAK1) selective inhibitor for the treatment of moderate to severe Atopic Dermatitis (AD). Selective inhibition of JAK1 with abrocitinib modulates signaling by Interleukin-4 (IL-4), Interleukin (IL-13), and other cytokines \[eg, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP)\] involved in the pathogenesis of Atopic Dermatitis and pruritus. This is a randomized, open label, parallel group study to assess the safety and efficacy of orally administered tablets of abrocitinib in participants aged 12 years and older with moderate to severe AD in India. There is a planned treatment duration of 12 weeks, with 4 weeks of off-treatment safety follow up thereafter. This study protocol also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee magnetic resonance imaging (MRI). Adolescent participants (12 to \<18 years of age) will continue to receive study intervention until 1 year after randomization into the main study.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Abrocitinib 100 mg	Orally administered, abrocitinib 100 mg tablets QD
DRUG	Abrocitinib 200 mg	Orally administered, abrocitinib 200 mg tablets QD.

Timeline

• Start date: 2022-07-16
• Primary completion: 2023-06-09
• Completion: 2024-03-14
• First posted: 2022-05-17
• Last updated: 2024-10-15
• Results posted: 2024-09-19

Locations

15 sites across 1 country: India