Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Summary

Primary Objectives: * Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive * Part B:Long-term safety and tolerability of SAR445088 in CIDP Secondary Objectives: * Part A: * Safety and tolerability of SAR445088 in CIDP * Immunogenicity of SAR445088 * Efficacy of SAR445088 with overlapping SOC (SOC-Treated group) * Part B: * Durability of efficacy during long-term treatment with SAR445088 in CIDP * Long-term immunogenicity of SAR445088 in CIDP

Timeline

Start

2021-04-28

Primary completion

2025-10-01

Completion

2025-10-01

Publications

• Querol L, Lewis RA, Hartung HP, Van Doorn PA, Wallstroem E, Luo X, Alonso-Alonso M, Atassi N, Hughes RAC. An innovative phase 2 proof-of-concept trial design to evaluate SAR445088, a monoclonal antibody targeting complement C1s in chronic inflammatory demyelinating polyneuropathy. J Peripher Nerv Syst. 2023 Jun;28(2):276-285. doi: 10.1111/jns.12551. Epub 2023 May 31.

Drugs

Indications