LBCTR2023115331招募中2 期
A RANDOMIZED DOUBLE-BLIND PHASE IIA STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB AS ADJUNCT TREATMENT IN PREVENTION OF VASO-OCCLUSIVE EPISODES (VOE) IN SICKLE CELL DISEASE (SCD) - Crosswalk-c
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 至 55（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •Patients must meet the following criteria for study entry:
- •?Signed Informed Consent Form (ICF)
- •?Signed Assent Form when appropriate, as determined by patient’s age and individual site and country standards
- •?Age 12 to 55 years at time of signing ICF or Assent Form
- •?Body weight = 40 kg at screening
- •?Willingness and ability to comply with the study protocol including scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of the HVQ and PRO questionnaires through the use of an electronic device
- •?Male or female with confirmed diagnosis of sickle cell anemia (HbSS or HbSß0)
- •?Two or more (= 2) to =10 documented VOEs in the 12 months prior to randomization as determined by medical history (VOE should include the occurrence of typical symptoms, a visit to a specific medical facility and/or healthcare professional, and receipt of pain medication as defined for the medical facility VOE endpoint in
- •?If receiving concurrent SCD-directed therapy (e.g., hydroxyurea, L-glutamine, crizanlizumab, or voxelotor), the patient must have been on a stable dose, except for weight-based titration, with good adherence by the investigator’s assessment for a minimum of 3 months prior to study enrollment (Day 1). There should be no plans to modify the patients’ dosing throughout the study duration, other than for safety reasons.
- •?If receiving erythropoietin, the patient must have been prescribed this medication for the preceding 3 months and be dose-stabilized for at least 3 months prior to study enrollment (Day 1).
- •?Vaccinations:
- •oVaccination against N. meningitidis serotypes A, C, W, and Y prior to initiation of treatment. Vaccination against serotypes A, C, W, and Y should have been received < 3 years prior to initiation of study treatment, or must be up to date in accordance with the most current local guidelines or SOC, as applicable for patients with complement deficiency and SCD. If vaccination against serotypes A, C, W, and Y is not required per local SOC, the Advisory Committee on Immunization Practices (ACIP) 2020 guidelines should be used. Vaccination against serotype B should be administered in accordance with the most current local guidelines or SOC for patients with complement deficiency and SCD. Vaccination currency against serotypes A, C, W, Y, and B should be maintained throughout the study, including the safety follow-up, per local guidelines.
- •oVaccinations against H. influenza type B and S. pneumonia in accordance with most current SCD-specific guidelines or local SOC. If the vaccination(s) are not required per local guidelines, the ACIP guidelines should be used. Vaccination currency should be maintained throughout the study, including the safety follow-up, per local guidelines.
- •oNote, if any of the above vaccinations are received < 2 weeks before initiating treatment, appropriate antibiotic prophylaxis per local standard of practice must be initiated. Antibiotic prophylaxis should be continued until 2 weeks after the vaccination is complete.
- •?Patients who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation
- •?Otherwise appropriate medical history and physical and laboratory evaluation that are acceptable for inclusion in this clinical trial
- •?Adequate hepatic function, with ALT < 3 xULN at the time of screenin
排除标准
- •Exclusion Criteria:
- •Patients who meet any of the following criteria will be excluded from study entry:
- •?History of hematopoietic stem cell transplant
- •?Participating in a chronic transfusion program (preplanned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study. Episodic simple transfusion is permitted.
- •?History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment (crovalimab or placebo), including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product
- •?Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial
- •?Concurrent disease, treatment, procedure, surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the patient, or would, in the opinion of the investigator, preclude the patient’s safe participation in and completion of the study
- •?Hemoglobin <6 g/dL
- •?Substance abuse within 12 months prior to screening, in the investigator’s judgment
- •?Received prior treatment with crovalimab or other complement inhibitor therapy
- •?Known or suspected hereditary complement deficiency
- •?Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration
- •?Presence of fever (=380C) within 7 days before the first drug administration
- •?Immunized with a live attenuated vaccine within 1 month before first drug administration
- •?Pregnant or breastfeeding, or intending to become pregnant during the study or within 46 weeks (approximately 10.5 months) after the final dose of study treatment
- •oWomen of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
- •?History of malignancy within 5 years prior to screening and up to the first drug administration (Day 1), with the following exceptions:
- •oPatients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for > 5 years prior to study drug administration (Day 1) are eligible.
- •oPatients with curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix at any time prior to study drug administration (Day 1) are eligible.
- •oPatients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study drug administration (Day 1) are eligible
- •?Known HIV infection with documented CD4 count <200 cells/µL within 24 weeks prior to screening
- •?History of N. meningitidis infection within the prior 6 months
- •Kindly refer to the exclusion criteria p 46 on the protocol
研究者
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