CTRI/2023/12/060535进行中（未招募）3 期
A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Percentage of Participants with complete TMA response (cTMAr)
研究概览
简要总结
BO42353 is a single-arm, uncontrolled, multicenter, global Phase III study designed to evaluate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of Crovalimab in patients with aHUS, aged more than 12 years, and weighing more than 40 kg. Patients will be enrolled in three parallel cohorts, based on their previous exposure and response to complement inhibitor therapy. All cohorts will contribute to PK and safety evaluations of Crovalimab.
研究设计
- 研究类型
- Interventional
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Body weight 40 kg above at screening.
- •Vaccination against Neisseria meningitidis serotypes A, C, W, and Y; vaccination against serotypes B, according to national vaccination recommendations.
- •Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae, according to national vaccination recommendations.
- •For participants receiving other therapies (e.g., immunosuppressants, corticosteroids, mTORi, or calcineurin inhibitors: stable dose for 28 days.
- •For female participants of childbearing potential: an agreement to remain abstinent or use contraception.
- •Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of crovalimab.
- •Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant.
- •Onset of initial TMA presentation within 28 days prior to the first dose of crovalimab (for Naive Cohort only).
- •Documented treatment with either eculizumab or ravulizumab (for Switch Cohort only).
- •Clinical evidence of response to a C5 inhibitor (for Switch Cohort only).
- •Known C5 polymorphism (for C5 SNP Cohort only).
- •Poorly controlled TMA following treatment with another C5 inhibitor (for C5 SNP Cohort only).
排除标准
- •TMA associated with non-aHUS related renal disease.
- •Positive direct Coombs test.
- •Chronic dialysis and/or end stage renal disease.
- •Identified drug exposure-related TMA.
- •Presence or history of a condition that could trigger TMA, such as malignancy, bone marrow or organ transplant (other than kidney transplant) or autoimmune disease.
- •History of a kidney disease, other than aHUS.
- •History of Neisseria meningitidis infection within 6 months of study enrollment.
- •Known or suspected immune deficiency (e.g., history of frequent recurrent infections).
- •Positive HIV test.
- •Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration.
- •Presence of fever (38 degree Celcius above) within 7 days before the first crovalimab administration.
- •Multi-system organ dysfunction or failure.
- •Recent IVIg treatment.
- •Pregnant or breastfeeding or intending to become pregnant.
- •Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half lives of that investigational product, whichever is greater.
- •Recent use of tranexamic acid.
- •First initiation of plasma exchange/plasma infusions (PE/PI) not more than 28 days prior to first crovalimab administration (for Naive Cohort only).
- •PE/PI should not be administered within 6 hours of first crovalimab administration (for Naive Cohort only).
- •Receiving PE/PI within 8 weeks of the first crovalimab administration (Switch Cohort only) Positive for active Hepatitis B and C infection (HBV/HCV) (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment).
- •Cryoglobulinemia at screening (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment).
- •Documented condition leading to non-aHUS TMA: Thrombotic Thrombocytopenic Purpura (TTP), Shiga Toxin producing Escherichia Coli (STEC)-TMA, Pneumococcal HUS, TMA secondary to cobalamin C defect and TMA related to Diacylglycerol kinase ε (DGKE) nephropathy.
结局指标
主要结局
Percentage of Participants with complete TMA response (cTMAr)
时间窗: Baseline up to Week 25
次要结局
- Naive and Switch Cohort:(Dialysis requirement status, change from baseline to Week 25)
- Switch Cohort:(Proportion of patients with maintained TMA control (mTMAc) from baseline through Week 25 (after 24 weeks on treatment))
- Naive Cohort Only:(Proportion of patients with platelet count more than LLN at two separate assessments, obtained at least 4 weeks (28 days) apart, by Week 25)
研究者
研究点 (3)
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