Chronic inflammatory demyelinating polyneuropathy nerve disorder
Conditions
Interventions
- Part A: Dosing will begin on Day 1 with a single IV loading dose of 50 mg/kg,
followed by 600 mg weekly subcutaneous injections from Week 2 to Week 24.
- Part B: Dosing will continue as 600 mg wee
Sponsors
Sanofi B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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 and women. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
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 longer. - Immunosuppressive/chemotherapeutic medications 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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: SOC-Treated: • Percentage of participants relapsing after withdrawal of SOC and during the BIVV020 treatment period (up to Week 24). Relapse will be defined as >=1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. SOC-Refractory: • Percentage of participants responding during the BIVV020 treatment period (up to Week 24). Response will be defined as >=1-point decrease in adjusted INCAT disability score. SOC-Naïve: • Percentage of participants responding during the BIVV020 treatment period (up to Week 24). Response will be defined as >=1-point decrease in adjusted INCAT disability score. Part B: • Incidence, severity, seriousness, and relatedness of adverse events (AEs) during the entire BIVV020 treatment period and follow-up period (Day 1 up to Week 98). | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: • Incidence, severity, seriousness, and relatedness of AEs during the treatment and follow-up period (up to Week 46) • Incidence and titer of anti-BIVV020 antibodies during the treatment and follow-up period (up to Week 46) • Percentage of participants in the SOC-Treated group improving during the overlap treatment period (up to Week 12). Improvement will be defined as a >=1 point decrease in adjusted INCAT disability score. Part B: • Percentage of participants with lasting efficacy during the treatment extension period (from Week 24 up to Week 76), ie, relapse-free (SOC-Treated) or with sustained response (SOC-Refractory and SOC-Naïve), defined as no increase in adjusted INCAT disability score >=2 points). • Incidence and titer of anti-BIVV020 antibodies during the entire BIVV020 treatment period and follow-up period (Day 1 up to Week 98). | — |
Countries
Netherlands
Outcome results
None listed