J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab
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New Delhi: In order to evaluate safety of Ustekinumab in Indian subjects with Crohn’s Disease (CD), pharmaceutical major, Johnson & Johnson has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV trial of Ustekinumab Pre-filled syringes 45 mg/0.5 ml, 90 mg/ml and Single use vial 130 mg/ 26 ml.
This came after the firm presented the protocol to conduct a Phase IV clinical trial titled “An Open Label, Multicenter, Phase IV Study of Ustekinumab to evaluate its safety in Indian subjects with Crohn’s Disease (CD)” vide protocol CNTO1275CRD4045".
Ustekinumab injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Ustekinumab prevents human IL-12 and IL-23 from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of NK and T cells (Fig. 4). This defines the molecular mechanism of action of ustekinumab.
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