A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of DNTH103 in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Chronic Inflammatory Demyelinating Polyneuropathy

Part B: Time from first dose to relapse as assessed by the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)

Part B: Time to decrease of ≥ 4 points (centile metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) score, Part B: Time to a decrease of ≥ 8 kilopascal (kPa) in grip strength in the dominant hand, Part B: Proportion of participants who relapse as assessed by the adjusted INCAT, Parts A and B: Change in I-RODS score, Parts A and B: Change in grip strength in the dominant hand, Parts A and B: Change in adjusted INCAT Score, Parts A and B: Change in grip strength in the nondominant hand, Parts A and B: Change in Medical Research Council Sum Score (MRC-SS), Part A: Proportion of participants with a confirmed response to DNTH103 as assessed by the adjusted INCAT, Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS), Parts A and B: Change in Fatigue Severity Scale (FSS), Parts A and B and OLE: Change in adjusted INCAT score, Part B and OLE: Proportion of participants with a confirmed relapse as assessed by the adjusted INCAT, Parts A, B, OLE, and Safety Follow-up: Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs), Parts A, B, OLE, and Safety Follow-up: Serum concentrations of DNTH103, Parts A, B, and OLE: Change from baseline in complement total blood test (CH50), Parts A, B, OLE, and Safety Follow-up: Incidence and titer of antidrug antibodies (ADAs)

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