Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Dupilumab-Subcutaneous: The recommended dose of Dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W).
Durat
Sponsors
Sanofi Healthcare India Pvt. Ltd
SANOFI HEALTHCARE INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant must be = 18 years of age, at the time of signing the informed consent. 2. Atopic dermatitis (AD) as defined by American Academy of Dermatology Consensus Criteria, that has been present for at least =1 year prior to screening 3. Participants with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable 4. Candidate for systemic therapy (disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable) 5. Male or Female 6. Participant with pruritus NRS = 4 at baseline 7. 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
Exclusion criteria: 1. Any contraindications according to the PI 2. Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening 3. Patients with known helminth infection (current andor past infection). 4. 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 5. Participation in a prior dupilumab clinical trial or any prior use of dupilumab 6. Immunosuppressive or 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 7. Has a history of or ongoing drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe safety of dupilumab in Indian adult patients with moderate-to-severe Atopic DermatitisTimepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe efficacy of dupilumab in Indian adult patients with moderate-to-severe Atopic DermatitisTimepoint: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at week 16 | — |
Countries
India
Contacts
Public ContactLaxman Deshmukh
Sanofi Healthcare India Pvt. Ltd.
Outcome results
None listed