NCT04658472

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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 childbearing potential.

Conditions

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

Type	Name	Description
DRUG	SAR445088 (IV)	Pharmaceutical form: Solution for Injection Route of Administration: Intravenous (IV)
DRUG	SAR445088 (SC)	Pharmaceutical form: Solution for Injection Route of Administration: Subcutaneous (SC)

Timeline

• Start date: 2021-04-28
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2020-12-08
• Last updated: 2025-10-28

Locations

32 sites across 10 countries: United States, Canada, China, France, Germany, Italy, Netherlands, Poland, Serbia, Spain

Regulatory

• FDA-regulated drug study