EUCTR2020-004006-54-FR进行中（未招募）1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 BIVV020 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
- •- 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).
- •- SOC-Naïve (all criteria a-c must be met): a) Participants without previous
- •treatment for CIDP or participants who received immunoglobulins (IVIg or SCIg) or
- •corticosteroids but were stopped for reasons other than lack of response or side effects.
- •b) Not treated with immunoglobulins (IVIg or SCIg) or corticosteroids for at least 6 months
- •prior to screening. c) INCAT score: 2-9 (a score of 2 should be exclusively from leg
- •disability component of INCAT.
- •- Documented vaccinations against encapsulated bacterial patho
排除标准
- •- 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
- •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 BIVV020 or its components
- •or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal
- •- Presence of conditions (medical history or laboratory assessments) that may
- •predispose the participant to excessive bleeding or increased risk of infection.
- •- A history of CIDP relapse after prior vaccination.
- •- Recent or planned major surgery that could confound the results of the trial or
- •put the participant at undue risk.
- •- 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 such as azathioprine,
- •methotrexate, cyclophosphamide, cyclosporine, mycophenolate mofetil, tacrolimus,
- •interferon, TNF-alpha inhibitor: 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, eg, mitoxantrone, alemtuzumab, cladribine.
- •- 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.
- •- Pregnant (defined as positive ß-HCG blood test) or lactating females.
- •- Positive result on any of the following tests: hepatitis B surface (HBsAg) antigen,
- •antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies,
- •anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2
- •antibodies).
- •- Evidence of IgG4 autoantibodies against paranodal proteins (NF155 and
研究者
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