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.
Ustekinumab is used to treat plaque psoriasis, a specific type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn’s disease, ulcerative colitis). It works by blocking specific natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions.
At the recent SEC meeting for Gastrology and Hepatology held on 16th and 17th March 2023, the expert panel reviewed the protocol for 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.
After detailed deliberation, the committee recommended the approval of the presented Phase IV study protocol.
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