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)
- Conditions
- Chronic inflammatory demyelinating polyneuropathynerve disorder10012303
- Registration Number
- NL-OMON54382
- Lead Sponsor
- Sanofi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A:<br /><br>SOC-Treated:<br /><br>• Percentage of participants relapsing after withdrawal of SOC and during the<br /><br>BIVV020 treatment period (up to Week 24). Relapse will be defined as >=1-point<br /><br>increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT)<br /><br>disability score.<br /><br>SOC-Refractory:<br /><br>• Percentage of participants responding during the BIVV020 treatment period (up<br /><br>to Week 24). Response will be defined as >=1-point decrease in adjusted INCAT<br /><br>disability score.<br /><br>SOC-Naïve:<br /><br>• Percentage of participants responding during the BIVV020 treatment period (up<br /><br>to Week 24). Response will be defined as >=1-point decrease in<br /><br>adjusted INCAT disability score.<br /><br><br /><br>Part B:<br /><br>• Incidence, severity, seriousness, and relatedness of adverse events (AEs)<br /><br>during the entire BIVV020 treatment period and follow-up period (Day 1 up to<br /><br>Week 98).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A:<br /><br>• Incidence, severity, seriousness, and relatedness of AEs during the treatment<br /><br>and follow-up period (up to Week 46)<br /><br>• Incidence and titer of anti-BIVV020 antibodies during the treatment and<br /><br>follow-up period (up to Week 46)<br /><br>• Percentage of participants in the SOC-Treated group improving during the<br /><br>overlap treatment period (up to Week 12). Improvement will be defined as<br /><br>a >=1 point decrease in adjusted INCAT disability score.<br /><br><br /><br>Part B:<br /><br>• Percentage of participants with lasting efficacy during the treatment<br /><br>extension period (from Week 24 up to Week 76), ie, relapse-free (SOC-Treated)<br /><br>or with sustained response (SOC-Refractory and SOC-Naïve), defined as no<br /><br>increase in adjusted INCAT disability score >=2 points).<br /><br>• Incidence and titer of anti-BIVV020 antibodies during the entire BIVV020<br /><br>treatment period and follow-up period (Day 1 up to Week 98). </p><br>