BMS Gets CDSCO Panel Nod to Study Deucravacitinib
New Delhi: The drug major BMS has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the drug Deucravacitinib in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
This came after the firm presented Phase III clinical trial study protocol no : IM011-247 protocol amendment 02 dated 07-09-2023.
This is a study to evaluate the effectiveness and safety of Deucravacitinib (BMS-986165) compared with placebo in participants with active systemic lupus erythematosus.
The official title of the study: " A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)"
Systemic lupus erythematosus (SLE) is an autoimmune disease. In this disease, the immune system of the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs.
Deucravacitinib is a novel oral selective tyrosine kinase 2 (TYK2) inhibitor. Unlike other Janus kinase 1/2/3 inhibitors that bind to the conserved active domain of these non-receptor tyrosine kinases, deucravacitinib binds to the regulatory domain of TYK2 with high selectivity to this therapeutic target. By inhibiting TYK2, deucravacitinib interferes with the signaling of IL-23, IL-12, and type I interferons, cytokines believed to play important roles in psoriasis pathogenesis.
At the recent SEC meeting for analgesic and rheumatology, the expert panel reviewed the Phase III clinical trial study protocol No.:IM011-247 protocol amendment 02 dated 07-09-2023.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
