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

NCT04658472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-10-28

No results posted yet for this study

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

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

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)

Sponsors & Collaborators

  • Bioverativ, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2025-10-01
Completion
2025-10-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658472 on ClinicalTrials.gov