Intas Pharmaceuticals has secured the green light from the Subject Expert Committee (SEC) of India's Central Drug Standard Control Organisation (CDSCO) to initiate a Phase III clinical trial of Ruxolitinib cream 1.5% w/w. The approval is subject to specific conditions aimed at enhancing the trial's rigor and representativeness. This development marks a significant step forward in evaluating a topical formulation of Ruxolitinib, a Janus kinase (JAK) inhibitor, for dermatological applications.
The SEC's approval is contingent upon Intas Pharmaceuticals submitting a revised clinical trial protocol that provides comprehensive details of the study centers involved. Furthermore, the committee stipulated that at least 50% of the study sites should be government hospitals, ensuring a diverse patient population. The inclusion criteria must also be revised to include participants aged 18 years and older, instead of the previously proposed 12 years and older.
Equivalence Study Requirements
Given that this trial is designed as an equivalence study, the CDSCO has requested additional documentation. Intas Pharmaceuticals must submit a detailed document outlining the need for the study and the rationale behind the chosen study design. This submission will allow the CDSCO to thoroughly review the scientific basis and methodology of the trial.
Ruxolitinib: A JAK Inhibitor
Ruxolitinib is classified as a Janus kinase (JAK) inhibitor, specifically targeting JAK1 and JAK2 protein kinases. It functions by competitively inhibiting the ATP-binding catalytic site on these kinases. This mechanism of action is crucial in modulating the signaling pathways involved in various inflammatory and myeloproliferative disorders.
Ruxolitinib is already used to treat myelofibrosis and polycythemia vera in patients who have not responded to or cannot tolerate hydroxyurea, and to treat graft-versus-host disease in cases that are refractory to steroid treatment. The development of a topical formulation aims to leverage its anti-inflammatory properties for dermatological conditions.
SEC Review Process
The SEC for dermatology and allergy convened on October 8, 2024, to review Intas Pharmaceuticals' proposal for conducting a Phase III clinical trial of Ruxolitinib cream 1.5% w/w. Following detailed deliberation, the committee recommended granting permission for the trial, subject to the aforementioned conditions. These conditions underscore the CDSCO's commitment to ensuring the safety, efficacy, and scientific validity of clinical trials conducted in India.
