eligibility_summary
Eligible: adults with moderate-to-severe plaque psoriasis, biologic-naïve. Exclude: active/latent TB, Hep B/C, HIV, immunocompromised by drugs/disease, systemic anti-psoriatic therapy within 3 months, personal/strong family history of heart disease, hepatic/renal comorbidities, or contraindication to biologics/biosimilars.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm Phase 1/2 trial in Pakistan testing infliximab-dyyb (Remsima/CT-P13), a biosimilar biologic anti–TNF-α chimeric IgG1 monoclonal antibody, given subcutaneously weekly ×4 then every 2 weeks to week 24, with follow-up to week 52, in biologic‑naïve adults with moderate–severe plaque psoriasis. Mechanism: binds soluble and transmembrane TNF‑α, preventing TNFR1/2 signaling and downstream NF‑κB activation, reducing proinflammatory cytokines (e.g., IL‑1, IL‑6), adhesion molecules, leukocyte recruitment, and keratinocyte hyperproliferation, may mediate Fc‑dependent lysis/apoptosis of TNF‑expressing cells. Targets: TNF‑α pathway across macrophages/monocytes, activated T cells (indirectly dampening Th1/Th17/IL‑23 axis), dendritic cells, endothelial cells, and keratinocytes. Outcomes: efficacy (severity/relapse) and safety.