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

  • End date
    Feb 11, 2025
  • participants needed
  • sponsor
    Bioverativ, a Sanofi company
Updated on 8 July 2022
mycophenolate mofetil
immune globulin
immunoglobulin therapy


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


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.

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


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.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note