Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

  • STATUS
    Recruiting
  • End date
    Feb 11, 2025
  • participants needed
    90
  • sponsor
    Bioverativ, a Sanofi company
Updated on 8 July 2022
corticosteroids
mycophenolate mofetil
cyclosporine
methotrexate
prednisone
immunoglobulins
polyneuropathy
azathioprine
igiv
immune globulin
immunoglobulin therapy

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

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: At the end of the Part B treatment period, participants will be asked to attend a safety follow-up visit that will take place 22 weeks after the last SAR445088 dose (Week 98).

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.

A follow-up telephone call at 56 weeks after last dose is included in the protocol, however the EoS has been defined as the last safety follow-up visit for the last patient which occurs at 22 weeks after last dose.

Details
Condition Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Treatment BIVV020, BIVV020/SAR445088
Clinical Study IdentifierNCT04658472
SponsorBioverativ, a Sanofi company
Last Modified on8 July 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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