A Phase 2, Multicenter, Open-label, Non-randomized, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of SAR445088 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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
Safety and tolerability of SAR445088 in CIDP
Immunogenicity of SAR445088
Efficacy of SAR445088 with overlapping SOC (SOC-Treated group)
Durability of efficacy during long-term treatment with SAR445088 in CIDP
Long-term immunogenicity of SAR445088 in CIDP
The duration of the study for a participant will include:
Part A Screening period: up to 6 weeks. Treatment period: once successfully screened,
enrolled participants will receive study intervention for 24 weeks.
Safety follow-up visit: participants who do not enroll (rollover) into Part B will be asked
to attend a final safety follow-up visit that will take place 22 weeks after Week 24, ie,
approximately at Week 46.
Part B Treatment period (extension): for all groups, this period will consist of 52 weeks of
treatment with SAR445088 (Weeks 24 to 76; Part A and B total treatment period of 76 weeks).
Safety follow-up visit: participants who do not enroll (rollover) into Part C will be asked
to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088
dose (Week 98).
Part C Treatment period: participants who complete Part B will be reassessed for continuing
eligibility, defined as having successfully completed Part B (received IMP until the Week 76
visit and have responded to SAR445088 based on Investigator's medical judgement), with no new
safety concerns. Eligible participants will be given the option of rolling into Part C, where
they will continue receiving SAR445088 until end of study.
End of study has been defined as the last safety follow-up visit for the last patient which
occurs 22 weeks after last dose.
In addition, there is a follow-up call 56 weeks ±14 days after last dose to confirm negative
result of urine pregnancy test for women of childbearing potential who are participating in
the study, or to query male participants regarding pregnancy of partners who are women of
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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