NL-OMON54382
Recruiting
Phase 2
A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of SAR445088 (previously BIVV020) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) - PDY16744
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic inflammatory demyelinating polyneuropathy
- Sponsor
- Sanofi B.V.
- Enrollment
- 6
- Status
- 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
- •\- Belonging to one of the following three groups: standard\-of\-care
- •(SOC)\-Treated, SOC\-Refractory or SOC\-Naïve, as defined in the protocol.
- •\- Documented vaccinations against encapsulated bacterial pathogens given within
- •5 years of enrollment or initiated a minimum of 14 days prior to first dose as
- •specified in Section 6\.8\.1 of the protocol.
- •\- Adherence to contraceptive requirements as detailed in the protocol for men
Exclusion Criteria
- •\- Polyneuropathy of other causes.
- •\- 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.
- •\- 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
Outcomes
Primary Outcomes
Not specified
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