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)

Sanofi-Aventis Recherche & Développement0 sites158 target enrollmentJanuary 19, 2021

ConditionsChronic inflammatory demyelinating polyneuropathy MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic inflammatory demyelinating polyneuropathy
Sponsor: Sanofi-Aventis Recherche & Développement
Enrollment: 158
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 19, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi-Aventis Recherche & Développement

Eligibility 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\-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 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.
•\- 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).

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.