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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 4 March 2024
Main ID:  NCT04658472
Date of registration: 01/12/2020
Prospective Registration: Yes
Primary sponsor: Bioverativ, a Sanofi company
Public title: Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Scientific title: A Phase 2, Multicenter, Open-label, Non-randomized, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of SAR445088 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Date of first enrolment: April 28, 2021
Target sample size: 110
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT04658472
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Canada China France Germany Italy Netherlands Poland Serbia
Spain United States
Contacts
Contact type:
Name:     Clinical Sciences & Operations
Address: 
Telephone:
Email:
Affiliation:  Sanofi
Key inclusion & exclusion criteria

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-Naive, 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 SAR445088 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 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-Naive (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,
polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, 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 SAR445088 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 SAR445088
dosing or until return of B-cell counts to normal levels, whichever is longer.

- Immunosuppressive/chemotherapeutic medications suc



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intervention(s)
Drug: SAR445088 (IV)
Drug: SAR445088 (SC)
Primary Outcome(s)
Part A, SOC-Treated: Percentage of participants relapsing after withdrawal of SOC and during the SAR445088 treatment period [Time Frame: Day 1 up to 24 weeks]
Part A, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants responding during the SAR445088 treatment period [Time Frame: Day 1 up to 24 weeks]
Part B: Number of participants reported with adverse events [Time Frame: Day 1 up to Week 98]
Secondary Outcome(s)
Part A: Number of participants reported with adverse events [Time Frame: Day 1 up to 46 Weeks]
Part B, SOC-Treated (initial dose group): Percentage of participants relapse-free during the treatment extension period [Time Frame: Week 24 up to Week 76]
Part A: Percentage of participants in the SOC-Treated group improving during the overlap treatment period [Time Frame: Day 1 up to 12 Weeks]
Part B, SOC-Refractory (initial and low dose group) and SOC-Naive: Percentage of participants with sustained response during the treatment extension period [Time Frame: Week 24 up to Week 76]
Part A: Number of participants with incidence and titer of anti-SAR445088 antibodies (ADA) [Time Frame: Day 1 up to 46 Weeks]
Part B: Long-term immunogenicity [Time Frame: Day 1 Up to Week 98]
Secondary ID(s)
U1111-1246-7023
2020-004006-54
PDY16744
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics:
Adverse events:
Outcome measures:
IPD sharing plan:
IPD sharing description:
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