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NCT07905547

PHASE4

A Study to Investigate Dupixent/ Dupilumab in Adult Indian Participants With Moderate-to-severe Atopic Dermatitis

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This study will describe safety of dupilumab in adult participants with atopic dermatitis. It will also look at the improvement of atopic dermatitis signs and symptoms in these participants. The maximum study duration would be 32 weeks which includes the below: * Up to 28 days of screening period in which the doctor will assess if the participant can be recruited in this study * Treatment duration is 16 weeks * Follow up period: during which the participant will be followed for 12 weeks to check for any safety events. Visit frequency: The visit frequency will be every 4 weeks during the 16 weeks treatment duration and then 12 weeks after the last dose of the study treatment. Total number of visits will be 7.

Official title: A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Dupilumab in Adult Indian Patients With Moderate-to-severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-28

Completion Date

2028-08-02

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Atopic Dermatitis

Interventions

DRUG

Dupilumab

Each single-use pre-filled syringe with needle shield contains 300 mg dupilumab in 2 mL solution.

Inclusion Criteria: * Atopic dermatitis (AD) as defined by American Academy of Dermatology Consensus Criteria, that has been present for at least more than equal to (≥)1 year prior to screening. * Participants with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. * Candidate for systemic therapy (disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable) * Participant with pruritus NRS ≥ 4 at baseline. * Capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol). Exclusion Criteria: * Any contraindications according to the principal investigator. * Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening. * Participants with known helminth infection (current and/or past infection). * Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research. * Participation in a prior dupilumab clinical trial or any prior use of dupilumab. * Immunosuppressive/immunomodulating drugs or live vaccines or phototherapy for AD within 4 weeks before baseline, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 2 weeks of study treatment. * Has a history of or ongoing drug or alcohol abuse. * Immunosuppressive/immunomodulating drugs or live vaccines or phototherapy for AD within 4 weeks before baseline, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 2 weeks of study treatment The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.