EUCTR2020-004006-54-FR
Active, not recruiting
Phase 1
Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic inflammatory demyelinatingpolyneuropathy
- Sponsor
- Sanofi-Aventis Recherche & Développement
- Enrollment
- 90
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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