2025-522165-30-00招募中3 期
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Xembify versus Gamunex-C in Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 20
- 主要终点
- AUC in the IV Phase: Steady-state AUC of total IgG over a 3-week dosing interval (τ) (i.e., AUC(0−21days) in participants with CIDP
研究概览
简要总结
To determine if the Immune Globulin Subcutaneous 20% (IGSC 20%, XEMBIFY) dose of 0.456 g/kg once weekly (QW) produces steady-state area under the concentration versus time curve (AUC) of total immunoglobulin G (IgG) that is non-inferior to that of the Immune Globulin Injection 10% (IGIV-C 10%, Gamunex-C) 1 g/kg every 3 weeks (Q3W) for up to 39 weeks in participants with CIDP.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥ 18 years of age at Screening.
- •Participants who can provide written informed consent.
- •Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP. See Appendix 1 of the study protocol for diagnostic criteria.
- •Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3−1.0 g/kg every 3 weeks (Q3W) inclusive and between 20−90 g of IGIV Q3W inclusive.
- •Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to Screening and through randomization.
- •Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
排除标准
- •Diagnosis of polyneuropathy of any other cause (including multifocal motor neuropathy; monoclonal gammopathy of uncertain significance with anti–myelinassociated glycoprotein IgM antibodies; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome; lumbosacral radiculoplexus neuropathy; polyneuropathy associated with diabetes mellitus; polyneuropathy associated with systemic illnesses; or drug or toxin induced polyneuropathy).
- •Known significant proteinuria (≥ 3+ or known urinary protein loss >1 g/24 hours or nephrotic syndrome), acute renal failure, are on dialysis, and/or have severe renal impairment on Screening laboratory testing (blood urea nitrogen [BUN] > 3 times the upper limit of normal [ULN] or creatinine more than 1.5 times ULN).
- •Screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding ≥ 2.5 times the ULN for the expected normal range for the testing laboratory.
- •Hemoglobin levels < 10 g/dL at Screening.
- •Current administration of anti-coagulation therapy which would make IGSC administration inadvisable per investigator judgement (i.e., vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [e.g., fondaparinux]).
- •Known hyperviscosity syndrome.
- •Known HIV, chronic hepatitis B virus (HBV), or chronic hepatitis C virus (HCV) infection.
- •Participation in another clinical trial within 30 days or if known, 5 half-lives of the interventional product prior to Screening (observational studies without investigative treatments [non-interventional] are permitted).
- •Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study such as the following: a. current malignancy or history of allogeneic bone marrow/stem cell transplant, b. cardiac insufficiency (New York Heart Association classes III/IV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension, c. chronic kidney disease stage IV or V, d. an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/μL [1.0 × 109/L]), or human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome, e. known bleeding disorders, f. severe skin disease at the planned injection sites, g. alcohol, drug or medication abuse, or h. other disorders where IGSC therapy would be contraindicated during the study.
- •History of a thrombotic episode (including deep vein thrombosis, known hypercoagulable state, myocardial infarction, pulmonary embolism, or thromboembolic stroke).
- •Known allergic or other severe adverse reactions to blood products including intolerability to previous IVIG up to 1 g/kg Q3W, history of hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, or severe generalized skin reaction.
- •Has had a CIDP relapse requiring treatment modification within 12 weeks prior to Screening or between Screening and randomization.
- •Treatment with any of the following: a. alemtuzumab or rituximab within 12 months of Screening. b. cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or fragment crystallizable receptor (FCRn) blockers, within 6 months of Screening. c. plasma exchange or complement inhibitors within 3 months of Screening. d. changes to the following treatment within 3 months of Screening: methotrexate, azathioprine, or mycophenolate or any other immunosuppressants within 6 months of Screening, e. participants on corticosteroids ≥ 20 mg/day prednisone equivalent. Participants on low dose corticosteroids (< 20 mg/day prednisone equivalent) may be enrolled if dose has been stable over the last 3 months prior to Screening and the dosage is not likely to be adjusted during the duration of the trial (inhaled or topical corticosteroids are allowed).
- •Participants requiring an IGIV dose equivalent to: a. greater than 1.0 g/kg every 3 weeks (Q3W) or b. less than 0.3 g/kg Q3W or c. greater than 90 g of IGIV Q3W or d. less than 20 g of IGIV Q3W.
- •Known IgA deficient patients with known antibodies against IgA
- •Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening (serum) or IV#1 Baseline (urine) (human chorionic gonadotropin [HCG]- based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, patch, vaginal ring, injectable or implanted hormonal methods of contraception, placement of an intrauterine device [IUD] or intrauterine system [IUS], condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study Note 1: Females of non-childbearing potential are postmenopausal or sterile (via hysterectomy, bilateral oophorectomy, or tubal ligation), defined as having no period for 12 consecutive months without alternative medical cause. Note 2: True abstinence: when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
研究组 & 干预措施
Xembify 200 mg/ml roztok pro subkutánní injekci
Test
干预措施: Xembify 200 mg/ml roztok pro subkutánní injekci (Drug)
Gamunex® 10%, 100 mg/ml, solution for infusion
Comparator
干预措施: Gamunex® 10%, 100 mg/ml, solution for infusion (Drug)
结局指标
主要结局
AUC in the IV Phase: Steady-state AUC of total IgG over a 3-week dosing interval (τ) (i.e., AUC(0−21days) in participants with CIDP
AUC in the IV Phase: Steady-state AUC of total IgG over a 3-week dosing interval (τ) (i.e., AUC(0−21days) in participants with CIDP
AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0−7days)) in participants with CIDP
AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0−7days)) in participants with CIDP
次要结局
- Steady-state mean trough (pre-dose) concentration of total IgG following IV administration of IGIV-C 10% Q3W or SC administration of IGSC 20% QW.
研究者
Scientific Innovation Office
Scientific
Grifols Therapeutics LLC
研究点 (20)
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