Submit clinical study data conducted in adults: CDSCO Panel Tells Sanofi on atopic dermatitis drug

New Delhi: Responding to the protocol amendment proposal for Amlitelimab study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sanofi that the data of clinical studies conducted in adults shall be submitted to CDSCO for further review by the committee before enrolment of adolescents and subjects less than 40 kg in weight.

This came after the drug maker Sanofi presented clinical trial Phase III protocol amendment 01 version 01 dated 20.11.2023 (protocol No. EFC17559). This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of Amlitelimab monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis.

Amlitelimab, a human anti-OX40 ligand monoclonal antibody, is under development for the treatment of atopic dermatitis, hidradenitis suppurativa, asthma, alopecia areata, celiac disease, and systemic sclerosis. Amlitelimab's mechanism focuses on OX40-Ligand and is tailored to recalibrate the balance between the body's pro-inflammatory and regulatory T cells.

At the recent meeting for Dermatology and Allergy held on July 11, 2024, the expert panel reviewed the clinical trial Phase III protocol amendment 01 version 01 dated 20.11.2023 (protocol No. EFC17559).

After detailed deliberation, the committee opined that the data of the clinical study conducted in adults should be submitted to CDSCO for further review by the committee before enrolling adolescents and subjects less than 40 kg.

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