Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis
New Delhi: In a recent regulatory development, the Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO) has recommended that Pfizer Products India Private Limited conduct a Phase IV clinical trial specifically in the adolescent population for its product Abrocitinib tablets 50 mg, 100 mg, and 200 mg.
The recommendation came after the firm sought a waiver to conduct an active surveillance study in lieu of the Phase IV trial for treating moderate-to-severe atopic dermatitis in patients aged 12 years and above.
The firm appeared before the committee during the SEC (Dermatology and Allergy) meeting held on June 11, 2025, in relation to its product Abrocitinib tablets 50 mg, 100 mg, and 200 mg, which are indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older who are candidates for systemic therapy.
Pfizer sought a waiver for Condition No. (X) to allow the conduct of an active surveillance study in lieu of a Phase IV clinical trial. The company informed the panel that this proposal had previously been discussed in the SEC meeting held on September 5, 2024, specifically for the adult population. At that time, the committee had already "opined to conduct the active surveillance study in adults population."
To support its current request, the company presented an overview of seven global Phase III studies conducted under the Abrocitinib clinical development program, along with a summary of real-world evidence. The committee also took note of the fact that a Phase III clinical trial (Study No. B7451094) had been conducted in India, involving 200 patients, of which 33 were adolescent subjects.
However, following detailed deliberation, the SEC recommended that Pfizer should conduct a Phase IV clinical trial specifically in the adolescent population, citing the following reasons:
a) "The number of Indian adolescent subjects in Phase III CT study was 33 (thirty-three) only."
b) "The data presented lacks long term safety findings in Indian adolescents population."
Abrocitinib, a Janus kinase (JAK) inhibitor, is part of Pfizer’s global dermatology portfolio and is used in managing moderate-to-severe atopic dermatitis that does not adequately respond to topical therapies.
