2024-515039-31-00已完成2 期
Isatuximab in type I cryoglobulinemia: A prospective pilot study / ICE STUDY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 9
- 主要终点
- Complete clinical response rate of cryoglobulinemia vasculitis symptoms at week (W) 20
研究概览
简要总结
The primary objective is to assess the complete clinical response rate of Isatuximab in type I IgG cryoglobulinemia.
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
- •Age > 18 years
- •Written informed consent
- •Monoclonal gammopathy of unknown significance (MGUS) with monoclonal IgG component
- •Active cryoglobulinemia vasculitis defined by positive (or history of positive) type I IgG cryoglobulinemia and a clinically active cryoglobulinemia with skin, joint, renal, pulmonary, cardiovascular, muscular, digestive, central and/or peripheral neurological involvement,
- •Treated naïve or relapsers type I cryoglobulinemia patients
- •Affiliated to National French social security system
- •Contraception : a) Male participants: A male participant must agree to use a highly effective method of contraception during the participation period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period. b) Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and with at least one of the following conditions: Not a female of childbearing potential (FCBP), OR A FCBP who must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 24 hours of starting study medication and must apply a highly effective method of contraception during the participation period and for at least 5 months after the last dose of study treatment and refrain from donating oocyte during this period
- •HIV negative serology; negative HBs Ag test; HCV negative serology or negative HCV RNA if positive HCV serology within 3 months prior inclusion
排除标准
- •Patient with a vasculitis unrelated to cryoglobulinemia
- •Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- •Hypersensitivity to the active substances (isatuximab and premedication) or to any of their excipients
- •Received any investigational drug within 14 days prior to inclusion or within 5 half-lives of the investigational drug, whichever is longer.
- •Participation in another interventional study or being in the exclusion period at the end of a previous study.
- •Vulnerable populations o pregnant or breastfeeding women o Persons deprived of liberty by judicial or administrative decision o Persons under psychiatric care without their consent o Adults subject to a legal protection measure o Persons unable to express their consent
- •Neutrophiles < 1000/mm3
- •Plaquettes < 75000/mm3
- •Patient with non-active cryoglobulinemia vasculitis,
- •Patient with diagnosis of multiple myeloma, except indolent myeloma
- •Patient treated with immunosuppressant (e.g alkylating agent, Rituximab, chemotherapy for plasma-cell neoplasms) introduced or increased in the month prior to the inclusion,
- •Live vaccines within 30 days prior to baseline or concurrently with Isatuximab
- •Infection requiring hospitalization and/or use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days prior Day
- •Active tuberculosis
- •HIV positive, positive Ag HbS, positive HCV RNA
- •Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
结局指标
主要结局
Complete clinical response rate of cryoglobulinemia vasculitis symptoms at week (W) 20
Complete clinical response rate of cryoglobulinemia vasculitis symptoms at week (W) 20
次要结局
- Safety and tolerability of treatment as assessed by frequency and severity of adverse clinical events at W20
- Complete, partial and non-clinical response rate at W12, and at W20.
- Rate of cryoglobulinemia clearance, of negativation of rheumatoid factor activity and of normalization of C4 complement level at W12, and at W20.
- Rate of early failures (non-clinical response at W4),
- Rate of renal complete remission defined as proteinuria <0.5g/24h or proteinuria/creatininuria <50 mg/mmol, disappearance of hematuria, and glomerular filtration rate ≥ 60ml/min/1.73m² at W12, and at W20.
- Clinical relapse rate defined by de novo appearance or reappearance of a manifestation attributable to cryoglobulinemia vasculitis during 48 weeks of follow-up,
- Course of plasma cell associated disorder W12, and at W20.
- Rate and time to relapse from baseline to W48
- Mean change of gammaglobulin level from baseline to W20
- Quality of life assessed by the mean variation of the SF-36 over the 20 weeks,
- Rate of infections (severe or not) and other complications during the 48 weeks of follow-up
- Proportion of patients remaining in remission with a BVAS=0 at baseline, W12, and W20.
- Evolution of Immunomonitoring (deep immunophenotyping, cytokines production, spectrometry, Fish analysis, single plasma cell repertoire) at baseline, week 12, and week 20
研究者
SAADOUN
Scientific
Assistance Publique Hopitaux De Paris
研究点 (9)
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