Johnson and Johnson Gets CDSCO Panel Nod To study Guselkumab in Psoriatic Arthritis
New Delhi: Pharmaceutical major Johnson and Johnson has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of Guselkumab in order to evaluate the safety and efficacy of Guselkumab administered subcutaneously in the treatment of Indian patients with psoriatic arthritis.
This came after Johnson and Johnson presented the proposal to conduct a Phase IV clinical trial titled “A Phase IV, Multicenter, Non‐Comparative, Open‐Label Study Evaluating the Safety and Efficacy of Guselkumab Administered Subcutaneously in the Treatment of Indian Patients with Psoriatic Arthritis” vide protocol number: CNTO1959PSA4018.
Psoriatic arthritis is a progressive inflammatory condition of the joints and the places where tendons and ligaments attach to bones (entheses). It happens when the immune system, for unknown reasons, becomes overactive and creates inflammation, leading to pain and swelling.
Guselkumab is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that selectively blocks interleukin-23. IL-23 is an inflammatory cytokine that activates the CD4+ T-helper (Th17) cell pathway to mediate the inflammatory cascade that induces psoriatic plaque formation.
Guselkumab targets the p19 alpha subunit of IL-23. While IL-23 promotes normal inflammatory and immune responses, the p19 and p40 subunits of IL-23 are found to be overexpressed in the condition of psoriasis and other autoimmune inflammatory skin diseases.
Guselkumab selectively binds to the p19 subunit of IL-23 in dendritic cells and keratinocytes and blocks its interaction with IL-23 receptor, which further prevents the release of other pro-inflammatory cytokines and chemokines via stimulation of immune cells such as Th17 cells. Thus, guselkumab blocks the abnormally heightened signaling of inflammatory cascades that promote epidermal abnormalities, including keratinocyte hyperproliferation and psoriatic plaque formation.
At the recent SEC meeting for analgesics and rheumatology held on January 28, 2025, the expert panel reviewed the proposal presented by Johnson and Johnson for conducting a Phase IV clinical trial titled “A Phase‐IV, Multicenter, Non‐Comparative, Open‐Label Study Evaluating the Safety and Efficacy of Guselkumab Administered Subcutaneously in the Treatment of Indian Patients with Psoriatic Arthritis” .
After detailed deliberation, the committee recommended the approval to conduct the clinical trial as per the protocol presented by the firm.
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