2025-524139-38-00招募中2 期
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 12
- 主要终点
- • Incidence and severity of AEs, SAEs, and AESIs • AEs/SAEs leading to discontinuation of surovatamig • Vital signs • Physical examination • Laboratory parameters • 12-lead ECG
研究概览
简要总结
To assess the safety and tolerability of surovatamig. To assess the effect of surovatamig on proteinuria.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.
- •Diagnosis of anti-PLA2R antibody-positive pMN according to KDIGO 2021 guidelines.
- •All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.
- •eGFR ≥ XXmL/min/1.73m2 (using the 2021 CKD-EPI creatinine equation).
- •Positive for anti-PLA2R.
- •Adequate haematological function.
- •Blood CD19+ B cells ≥ XX cells/μL at screening.
- •IgG levels ≥ XX g/L at screening.
- •Male and/or female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
- •Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.
- •Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.
- •History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks from signing ICF).
- •Participant with current or previous active or latent TB. Participant will be excluded from the study if any of the following criteria are met: (a) Signs or symptoms of active TB prior to or during screening. (b) Medical history or past physical examinations suggestive of active or latent TB. (c) A chest X-ray during the screening period or a chest X-ray or CT scan within 12 weeks prior to signing of the ICF with evidence of active or signs of prior TB infection. (d) Household contact with a person with active TB. (e) The participant must undergo a TB screen (QuantiFERON-TB Gold test), confirmed by the central laboratory at the screening visit. Participant will be excluded from the study with any of the following results: (i) Positive result. (ii) Indeterminate result. Test may be repeated once, no earlier than 2 months later. If upon retest the result is indeterminate, the participant is declared a screen failure.
- •Participant with HIV infection (confirmed by central laboratory at screening).
- •Participant with active EBV or CMV, assessed clinically.
- •Participant with evidence of chronic or active hepatitis B, defined as HBsAg positive or HBcAb positive (tested at screening visit).
- •Participant with evidence of chronic or active hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA > 12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).
- •Abnormal vital sign after 10 minutes sitting at rest.
- •ECG abnormalities that, in the Investigator’s opinion, make the participant unsuitable for study participation.
- •Secondary causes of membranous nephropathy (autoimmune or infectious diseases, neoplasms, etc), HIV infection, liver disease.
- •Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent < 2 months before screening.
- •Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, or rituximab) < 9 months before screening.
- •Immunomodulatory therapy <3 months before screening.
- •Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
- •Malignancies: • Concurrent malignancy except for treated non-melanoma skin cancer, cervical carcinoma in situ, and low-risk prostate cancer being monitored without treatment. • Any malignancy within the past 3 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or low risk prostate cancer without evidence of progression. • Case-by-case investigators review for rare malignancies with definitive cure and minimal recurrence risk when supported by documentation from the treating oncologist.
- •History of HLH/MAS.
- •Significant CNS co-morbidity (eg, Parkinson’s, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy/seizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).
- •Recent history (within 6 months of signing ICF) or current diagnosis of ongoing clinically significant specific diseases as per protocol.
- •Significant opportunistic infection in the medical history deemed relevant by the Investigator.
- •Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary)
研究组 & 干预措施
AZD0486, AZD0486
Test
干预措施: AZD0486 (Drug)
结局指标
主要结局
• Incidence and severity of AEs, SAEs, and AESIs • AEs/SAEs leading to discontinuation of surovatamig • Vital signs • Physical examination • Laboratory parameters • 12-lead ECG
• Incidence and severity of AEs, SAEs, and AESIs • AEs/SAEs leading to discontinuation of surovatamig • Vital signs • Physical examination • Laboratory parameters • 12-lead ECG
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) at 6 months.
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) at 6 months.
次要结局
- Time to relapse after complete or partial remission up to 24 months
- Time to a ≥ 3 months sustained reduction of eGFR ≥ XX from baseline up to 24 months
- Change from baseline in Patient Reported Outcome
- Serum PK parameters of surovatamig, including but not limited to AUC and Cmax
- Treatment-emergent ADAs
- Change from baseline in B-cell count in peripheral blood to 24 months
- Change from baseline in anti-PLA2R antibody titer to 24 months
- Percentage of participants achieving complete or partial remission of pMN at 24 months −Complete remission: reduction of proteinuria from baseline to a value ≤ XX g/24 h plus stable kidney function −Partial remission: reduction of proteinuria > XX from baseline and a value < XX g/24 h plus stable kidney function. Note: A stable kidney function is defined as a GFR that remains unchanged or declines by < XX.
- Percentage of participants achieving complete remission of pMN at 24 months. Percentage of participants achieving partial remission of pMN at 24 months.
- Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) to 24 months
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (12)
Loading locations...
相似试验
招募中
2 期
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney DiseasePrimary Membranous NephropathyNCT07571746AstraZeneca43
招募中
1 期
A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid TumorsNCT07298772Suzhou Suncadia Biopharmaceuticals Co., Ltd.198
招募中
1 期
Study of Intrathecal ELP-02 for Charcot-Marie-Tooth Disease Type 4J (CMT4J)NCT07447557Elpida Therapeutics SPC8
招募中
2 期
A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant TumorsNCT07448922Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.280
招募中
1 期
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.CRCNCT07283367Hansoh BioMedical R&D Company502