Revise Phase III CT protocol of Olokizumab as a single-arm study: CDSCO Panel Tells Dr Reddys
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Dr Reddy's Laboratories to revise the Phase III clinical trial protocol of the rheumatoid arthritis drug Olokizumab as a single-arm study and avoid the placebo arm since the patients have moderate to severe rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX).
This came after Dr Reddy's Laboratories presented the proposal to conduct a Phase III clinical trial titled “A phase III, randomized, double-blind,placebo-controlled, parallel-group, multicentre study to evaluate the efficacy and safety of olokizumab in moderate to severe rheumatoid arthritis patients with inadequate response to methotrexate” vide protocol number OKZ-01-002, version 1.0 dated 17 Jan 2023.
Olokizumab is a humanized anti-IL-6 IgG4κ antibody under investigation for use in autoimmune conditions including rheumatoid arthritis.
The humanized monoclonal antibody olokizumab has a special mode of action by directly suppressing IL-6 (site III). The safety and efficacy of olokizumab were confirmed in large international randomized trials both in biologically naïve patients and in patients with resistance to tumour necrosis factor-alpha inhibitors.
Olokizumab binding induces conformational changes in IL-6 that cause occlusion of the gp130 binding site between trp157 and residues 50-60. By inhibiting gp130 binding, olokizumab inhibits both classical and trans-signalling.
Rheumatoid arthritis, or RA, is an autoimmune and inflammatory disease, which means that your immune system attacks healthy cells in your body by mistake, causing inflammation (painful swelling) in the affected parts of the body.
At the recent SEC meeting for analgesic and rheumatology held on 5th October 2023, the expert panel reviewed the proposal presented by Dr Reddy's Laboratories to conduct a Phase III clinical trial titled “A phase III, randomized, double-blind,placebo-controlled, parallel-group, multicentre study to evaluate the efficacy and safety of olokizumab in moderate to severe rheumatoid arthritis patients with inadequate response to methotrexate” vide protocol number OKZ-01-002, version 1.0 dated 17 Jan 2023.
After detailed deliberation, the committee recommended that the firm should revise the protocol as a single-arm study and avoid the placebo arm since the patients have moderate to severe RA with inadequate response to MTX.
In addition, the expert panel noted that the rescue therapy is proposed only after twelve weeks as per the protocol presented.
Accordingly, the committee suggested that the firm should submit a revised protocol to CDSCO for further evaluation by the committee.
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