Part A: Efficacy of BIVV020 across three subpopulations of CIDP patients: standard of
care (SOC)-Treated, SOC-Refractory and SOC-Naive
Part B:Long-term safety and tolerability of BIVV020 in CIDP
-Part A: Safety and tolerability of BIVV020 in CIDP
Immunogenicity of BIVV020
Efficacy of BIVV020 with overlapping SOC (SOC-Treated group)
Durability of efficacy during long-term treatment with BIVV020 in CIDP Long-term
immunogenicity of BIVV020 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 BIVV020 (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 BIVV020 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
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.
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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