Expert Panel Tells IPCA to Revise Hydroxychloroquine Phase III Trial for Diabetes
New Delhi: In response to the proposal presented by IPCA Laboratories Limited, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) opined to revise the protocol of the anti-malarial drug Hydroxychloroquine.
This came after the firm presented the proposal for grant of permission to conduct Phase III clinical trial vide protocol No. Ipca/HYDR/PIII-24, Version: 01, dated 29.07.2024 before the committee for Evaluation of Efficacy and Safety of Hydroxychloroquine in uncontrolled type 2 diabetes patients with Dyslipidemia and Stable Atherosclerotic Cardiovascular Disease.
The committee noted that single primary objective and multiple secondary objectives are mentioned in the Phase III protocol presented by firm.
Hydroxychloroquine is in a class of drugs called antimalarials and is also an antirheumatic drug. It works by killing the organisms that cause malaria. Hydroxychloroquine may work to treat rheumatoid arthritis and systemic lupus erythematosus by decreasing the activity of the immune system.
The primary mechanism by which hydroxychloroquine modulates systemic lupus erythematosus is by suppressing activation of Toll-like receptors, which exist on the surface of endosomes and play a significant role in the innate immune response and in autoimmune disease. Their activation is necessary for the expression of interferon-regulated genes and production of tumor necrosis factor alpha, which are key in the cell-mediated inflammatory response.
At the recent SEC meeting for Endocrinology and Metabolism held on 22nd April 2025, the expert panel reviewed the proposal for grant of permission to conduct Phase III clinical trial vide protocol No. Ipca/HYDR/PIII-24, Version: 01, dated 29.07.2024 before the committee for Evaluation of Efficacy and Safety of Hydroxychloroquine in uncontrolled type 2 diabetes patients with Dyslipidemia and Stable Atherosclerotic Cardiovascular Disease.
After detailed deliberation, the committee opined to revise the protocol as below-
1) Primary objectives and secondary objectives to be redefined based on terminology available in Scientific literature and therapeutic rationale.
2) Atherosclerotic Cardiovascular Disease to be defined in the protocol.
"Accordingly, the firm should submit revised protocol to CDSCO," the Committee noted.
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