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

  • STATUS
    Recruiting
  • End date
    May 17, 2024
  • participants needed
    90
  • sponsor
    Bioverativ, a Sanofi company
Updated on 23 January 2022
corticosteroids
mycophenolate mofetil
cyclosporine
methotrexate
prednisone
immunoglobulins
polyneuropathy
azathioprine
igiv
immune globulin
immunoglobulin therapy

Summary

Primary Objective:

  • 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

Secondary Objective:

-Part A: Safety and tolerability of BIVV020 in CIDP

  • Immunogenicity of BIVV020
  • Efficacy of BIVV020 with overlapping SOC (SOC-Treated group)
  • Part B:

Durability of efficacy during long-term treatment with BIVV020 in CIDP Long-term immunogenicity of BIVV020 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 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 (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
Clinical Study IdentifierNCT04658472
SponsorBioverativ, a Sanofi company
Last Modified on23 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults ≥18 years of age at the time of signing the informed consent
Documented definite or probable diagnosis of CIDP (typical CIDP, pure motor CIDP, or Lewis-Sumner Syndrome) according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) Task Force first revision
Belonging to one of the following three groups: standard-of-care (SOC)-Treated, SOC-Refractory or SOC-Naïve, as defined below
SOC-Treated (all criteria a-c must be met): a) Documented evidence of objective response to SOC, with clinically meaningful improvement. Clinically meaningful improvement is defined as one of the following: ≥1-point decrease in adjusted INCAT score, ≥4 points increase in RODS total score, ≥3 points increase in MRC Sum score, ≥8 kilopascal improvement in mean grip strength (one hand), or an equivalent improvement based on information documented in medical records and per the PI's judgement. b) Must be on stable SOC therapy, defined as no change greater than 10% in frequency or dose of immunoglobulin therapy or corticosteroids within 8 weeks prior to screening, remaining at stable SOC therapy until the time of first BIVV020 dosing. c) Evidence of clinically meaningful deterioration on interruption or dose reduction of SOC therapy within 24 months prior to screening, determined by clinical examination or medical records
Clinically meaningful deterioration is defined as one of the following: ≥1-point increase
in adjusted INCAT score, decrease in RODS total score ≥4 points, decrease in MRC Sum score
≥3, mean grip strength worsening of ≥8 kilopascals (one hand), or an equivalent
deterioration based on information from medical records and at the PI's judgement
SOC-Refractory (all criteria a-d must be met): a) Evidence of failure or inadequate
response to SOC defined as no clinically meaningful improvement and persistent INCAT
score ≥2 after treatment for a minimum of 12 weeks on SOC prior to screening. A
clinically meaningful improvement is defined as one of the following: ≥1-point
decrease in adjusted INCAT score, increase in RODS total score ≥4 points, increase in
MRC Sum score ≥3, mean grip strength improvement of ≥8 kilopascals (one hand), or
equivalent improvement based on information from medical records and at the PI's
judgement. Or
Unable to receive or continue treatment with immunoglobulins or corticosteroids due to
side effects
b) Patient has not received immunoglobulins (IVIg or SCIg) within 12 weeks prior to
screening. c) Certain immunosuppressant drugs are allowed in this group if taken for
≥6 months and at a stable dose for ≥3 months prior to screening: azathioprine
methotrexate, mycophenolate mofetil and cyclosporine. Oral corticosteroids are allowed
if Protocol Registration Form Page 5 of 12 Property of the Sanofi Group - strictly
confidential Version number: 1.0, dated 27-mar-2020 on a stable dose of <20 mg/day of
prednisone (or equivalent dose for other oral corticosteroids) for ≥3 months prior to
screening. d) INCAT score: 2-9 (a score of 2 should be exclusively from leg disability
component of INCAT)
SOC-Naïve (all criteria a-c must be met): a) Participants without previous treatment
for CIDP or participants who received immunoglobulins (IVIg or SCIg) or
corticosteroids but were stopped for reasons other than lack of response or side
effects
b) Not treated with immunoglobulins (IVIg or SCIg) or corticosteroids for at least 6
months prior to screening. c) INCAT score: 2-9 (a score of 2 should be exclusively
from leg disability component of INCAT
Documented vaccinations against encapsulated bacterial pathogens given within 5 years
of enrollment or initiated a minimum of 14 days prior to first dose
A female participant must use a double contraception method including a highly
effective method of birth control from inclusion and up to 52 weeks plus 30 days after
the last study dose and agree not to donate eggs, ova or oocytes during this period
A female participant must have a negative highly sensitive pregnancy test (urine or
serum) as required by local regulations within 24 hours before the first dose of study
intervention
Male participants, whose partners are of childbearing potential must accept to use
during sexual intercourse, a double contraceptive method according to the following
condom plus an additional highly effective contraception
Male participants must have agreed not to donate sperm during the intervention and up
to 52 weeks after the last dose
Capable of giving signed informed consent

Exclusion Criteria

Polyneuropathy of other causes, including but not limited to hereditary demyelinating
neuropathies, neuropathies secondary to infection or systemic disease, diabetic
neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy
monoclonal gammopathy of uncertain significance, lumbosacral radiculoplexus
neuropathy, pure sensory CIDP and acquired demyelinating symmetric (DADS) neuropathy
(also known as distal CIDP)
Any other neurological or systemic disease that can cause symptoms and signs
interfering with treatment or outcome assessments
Poorly controlled diabetes (HbA1c >7%)
Serious infections requiring hospitalization within 30 days prior to screening and any
active infection requiring treatment during screening
Clinical diagnosis of SLE
Sensitivity to any of the study interventions, or components thereof, or drug or other
allergy that, in the opinion of the Investigator, contraindicates participation in the
study. Specifically, history of any hypersensitivity reaction to BIVV020 or its
components or of a severe allergic or anaphylactic reaction to any humanized or murine
monoclonal antibody
Participants with a history of suicidality in the six months prior to screening or
currently at risk of committing suicide
Presence of conditions (medical history or laboratory assessments) that may predispose
the participant to excessive bleeding or increased risk of infection
Evidence of CIDP relapse within 6 weeks after receiving a vaccination
Recent or planned major surgery that could confound the results of the trial or put
the participant at undue risk
Treatment with plasma exchange within 12 weeks prior to screening
Prior treatment with rituximab or ocrelizumab in the 6 months prior to BIVV020 dosing
or until return of B-cell counts to normal levels, whichever is longer
Immunosuppressive/chemotherapeutic medications such as azathioprine, methotrexate
cyclophosphamide, cyclosporine, mycophenolate mofetil, tacrolimus, interferon
TNF-alpha inhibitor: within 6 months prior to dosing (except for some cases as
indicated in the SOC-Refractory group)
Treatment (any time) with highly immunosuppressive/chemotherapeutic medications with
sustained effects, eg, mitoxantrone, alemtuzumab, cladribine
Treatment (any time) with total lymphoid irradiation or bone marrow transplantation
Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5
times the half-life of the product, whichever is longer, prior to screening
Pregnant (defined as positive β-HCG blood test) or lactating females
Positive result on any of the following tests: hepatitis B surface (HBsAg) antigen
antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV)
antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and
anti-HIV2 antibodies)
Evidence of IgG4 autoantibodies against paranodal proteins (NF155 and CNTN1)
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