LBCTR2024045330招募中1 期
A Phase IB Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD) - Crosswalk-a
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
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
- •Key Inclusion Criteria
- •Screen Visit #1 (Initial Screen)
- •?Signed ICF or Assent Form (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, and VOE presentation
- •?Body weight >=40 kg
- •?Willingness and ability to comply with all study visits and procedures
- •?Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia)
- •?Vaccination against N. meningitidis serotypes A, C, W, and Y prior to initiation of study 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.
- •– If vaccination(s) are incomplete or vaccination status is unknown at VOE presentation, or vaccination(s) were received < 2 weeks before treatment administration, appropriate antibiotic prophylaxis per local clinical practice must be initiated. Antibiotic prophylaxis should be continued until the required vaccination(s) are completed and for an additional 2 weeks after completion
- •?Vaccinations against H. influenzae type B and S. pneumoniae 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.
- •– If vaccination(s) are incomplete or vaccination status is unknown at VOE presentation, or vaccination(s) were received < 2 weeks before treatment administration, appropriate antibiotic prophylaxis per local clinical practice must be initiated. Antibiotic prophylaxis should be continued until the required vaccination(s) are completed and for an additional 2 weeks after completion
- •?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, as long as it has been 3 days or more after inoculation with the vaccine.
- •Screen Visit #2 (VOE Presentation Screen)
- •?All criteria from Screen Visit #1 must be reconfirmed at Screen Visit #2
- •?Diagnosis of an acute uncomplicated VOE (for definition see Section 2.4.1), that requires admission to a hospital and treatment with parenteral opioid analgesics
- •?Pain score >= 2 as measured with the NRS on a 0-10 scale
- •?Ability to receive the single dose of study treatment within 12 hours from initial evaluation in the ER/ED or acute medical facility for the VOE (i.e., first vital signs measurements or first evaluation by a medical professional, whichever is first)
- •?Adequate hepatic function, including ALT < 3 x ULN and no clinical signs or known laboratory/radiographic evidence that are consistent with cirrhosis
- •?Adequate renal function, defined as c
排除标准
- •Exclusion Criteria:
- •Screen Visit #1 (Initial Screen)
- •?More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit (e.g., ER/ED, hospital, clinic, infusion center, day hospital, etc.), as determined by medical history or by patient recall
- •?History of hematopoietic stem cell transplant
- •?Known or suspected hereditary complement deficiency
- •?History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in crovalimab, including hypersensitivity to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product
- •?Current or previous treatment with a complement inhibitor therapy (e.g., crovalimab, eculizumab, or ravulizumab)
- •Screen Visit #2 (VOE Presentation Screen)
- •?All criteria from Screen Visit #1 must be reconfirmed at Screen Visit #2
- •?pain related to the current VOE ongoing for > 48 hours prior to VOE presentation
- •?Major surgery and/or hospitalization for any reason within 30 days prior to VOE presentation
- •?Acute pain related to avascular necrosis (where the presenting pain is limited to the affected joint), hepatic or splenic sequestration, or priapism per investigator assessment
- •?Pain atypical of an acute uncomplicated VOE that is the primary cause for presentation to the ER/ED or acute medical facility (e.g., chronic pain, abdominal pain, headache), or other alternative cause or explanation for pain presentation (e.g., infection, surgical pain) per investigator assessment
- •?Presentation with a critical illness necessitating ICU or critical care admission
- •?Evidence of or suspicion of ACS, defined as: the presence of new segmental radiographic pulmonary infiltrate involving at least one complete lung segment that is consistent with alveolar consolidation but excluding atelectasis, and at least one of the following additional signs or symptoms: chest pain, temperature >= 38.5oC (101.3oF), respiratory symptoms, or exam findings consistent with ACS
- •?Evidence or high suspicion of a severe systemic infection (e.g., osteomyelitis, pneumonia, meningitis, or sepsis) per investigator assessment
- •- Patients with uncomplicated infections (e.g., uncomplicated urinary tract infections, uncomplicated acute otitis media, streptococcal pharyngitis, minor viral infections) may be included as per investigator assessment
- •?Presence of fever >= 38oC (100.oF)
- •?Infection requiring hospitalization or treatment with IV antibiotics within the prior 28 days, or oral antibiotics within the prior 14 days of VOE presentation
- •– Patients on prophylactic antibiotics may be included
- •?History of N. meningitidis infection within 6 months prior to VOE presentation
- •?Known HIV infection with a documented CD4 count <200 cells/µL within 24 weeks prior to VOE presentation
- •?Transfusion or receipt of blood products within 3 months prior to VOE presentation or as part of BSC regimen for the current VOE, or current participation in a chronic transfusion protocol
- •?Immunized with a live attenuated vaccine within 30 days prior to VOE presentation
- •?Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration
- •– Women of childbearing potential must have a documented negative pregnancy test result (urine or serum). If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test
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