Lupin Gets Expert Committee Nod To Conduct Phase I Trial of Certolizumab Pegol, IGRA TB Test Made Mandatory
New Delhi: Lupin has got approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase I study of Certolizumab Pegol 200 mg solution for injection (200 mg/mL) in PFS.
However, the nod is subject to the condition that the Interferon-Gamma Release Assay (IGRA) test for latent TB should be a part of the screening of subjects in the study.
This came after the drug maker Lupin presented the protocol to conduct Phase I study titled "A Double Blind, Balanced, Randomized, Single-Dose, Single-Period, Two-Treatment, Parallel Comparative Pharmacokinetics Study of Lupin’s Certolizumab pegol with US Licensed Cimzia (certolizumab pegol) in Healthy, Adult, Human Subjects" for export purpose vide Protocol No. LBC-P-015-25. Version: 00 Date: 21 Apr 2025.
Certolizumab pegol is a tumor necrosis factor (TNF) blocker used to treat a variety of autoimmune and autoinflammatory conditions like Crohn's disease, rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, and plaque psoriasis.
Certolizumab targets the activation of TNF-alpha with high affinity (KD 90 pM and IC90 0.004 mcg/ml), which inhibits the downstream inflammatory process. It acts by binding and neutralizing the soluble and membrane portions of TNF-alpha without inducing complement or antibody-dependent cytotoxicity due to the lack of the Fc region. The inhibition of TNF-alpha is achieved in a dose-dependent manner and it does not present activity against lymphotoxin alpha (TNF-beta).
Certolizumab pegol (Cimzia) is used to treat several inflammatory autoimmune diseases by neutralizing tumor necrosis factor-alpha (TNF-α), a chemical that causes inflammation. Its indications include Crohn's disease (CD), rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA).
At the recent SEC meeting for Gastroenterology and Hepatology, the expert panel reviewed the phase I protocol to conduct a Phase I study titled "A Double-Blind, Balanced, Randomized, Single-Dose, Single-Period, Two-Treatment, Parallel, Comparative Pharmacokinetics Study of Lupin’s Certolizumab Pegol with US Licensed Cimzia (certolizumab pegol) in Healthy, Adult, Human Subjects" for export purposes vide Protocol No. LBC-P-015-25. Version: 00 Date: 21 Apr 2025.
After detailed deliberation, the committee recommended the firm to conduct the clinical trial with the condition that IGRA test for latent TB should be a part of the screening of subjects in the study.
Accordingly, the expert panel suggested that the firm should submit a revised protocol to CDSCO for further evaluation.
