PACTR202106894720601招募中3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants with Sickle Cell Disease and Recurrent Vaso-occlusive Crises
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant has an index VOC. The index VOC is any VOC that required admission to a healthcare facility and treatment with parenteral pain medication. An admission for the index VOC includes:
- •a.A hospital admission, or
- •b.An admission to an emergency room, observation unit, or infusion center for = 12 hours, or
- •c.2 visits to an emergency room, observation unit, or infusion center over a 72 hour period.
- •for an acute episode of pain with no other cause other than a vaso-occlusive event that includes the following:
- •-Uncomplicated VOC,
- •-Acute chest syndrome (ACS),
- •-Acute hepatic sequestration,
- •-Acute splenic sequestration, or
- •-Priapism.
- •2.Participant has a confirmed diagnosis of SCD any genotype).
- •Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing at Baseline.
- •3.Participant is male or female, = 12 years of age at the time of informed consent.
- •4.Participant is able to complete screening and receive study drug within 5 days following investigator-assessed resolution of index VOC (for example, hospital discharge, discontinuation of parenteral pain medication, or transition to oral pain medication).
- •Participant has experienced between 2 and 10 VOCs within the 12 months prior to Screening as determined by documented medical history. The index VOC is not to be considered as one of the 2 to 10 events. A prior VOC is defined as an acute episode of pain that:
- •a. Has no medically determined cause other than a vaso-occlusive event, and
- •b. Results in a visit to a healthcare facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
- •c. Requires parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
- •6. Participants receiving erythropoiesis-stimulating agents (ESA, eg, erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.
- •7. Participants receiving HU, L-glutamine, or voxelotor must be on a stable dose for at least 30 days prior to Screening and expected to continue with the stabilized regimen throughout the course of the study.
- •8. Participant has adequate venous access, in the opinion of the Investigator, to comply with study procedures.
- •9. Participant understands the study procedures and agrees to participate in the study by giving written informed consent or parental permission/written assent.
- •10. Women of childbearing potential (WOCBP) are required to have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test on all subsequent clinic visits and must agree to use a highly effective method of contraception throughout the study period and for at least 165 days after dosing.
- •Female participants will not be considered of childbearing potential if they are pre-menarchal, surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation, or bilateral oophorectomy) or postmenopausal (no menses for 12 months without an alternative medical cause, confirmed by follicle-stimulating hormone test results).
排除标准
- •1.Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
- •2.Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to Screening.
- •3.Participant weighs > 133 kg (292 lbs.).
- •4.Participant has a significant active and poorly controlled (unstable) hepatic disorder clearly unrelated to SCD.
- •5.Participant has any of the following laboratory values at Screening:
- •a.Absolute neutrophil count (ANC) < 1.0 × 109/L
- •b.Platelet count < 80 × 109/L
- •c.Hemoglobin < 4.0 g/dL for adults and < 5.0 g/dL for participants ages 12 to < 18 years of age
- •d.Estimated glomerular filtration rate (eGFR) < 30 mL/min using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula in adults, and Schwartz formula in adolescents.
- •6.Participant has known active (symptomatic) COVID infection or tests positive for COVID-19 at any time during their index admission.
- •7.Participant has a history of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to Screening including severe or unstable pulmonary hypertension.
- •8.Participant has had treatment for a malignancy within the 12 months prior to Screening (except non-melanoma skin cancer and in situ cervical cancers).
- •9.Participant has had a stroke within the 2 years prior to the Screening Visit.
- •10.Participant has a positive test indicative of active malaria infection at Screening. Testing to be conducted at local laboratories in malaria-endemic regions at the discretion of the Investigator.
- •11.Participant has any confirmed clinically significant drug allergy and/or known hypersensitivity to monoclonal antibody therapeutics or formulation components of the study drug or a related drug.
- •12.Participant has been treated with another investigational agent within 30 days or 5 half lives of the investigational agent (whichever is greater) prior to Screening.
- •Participant has had a major surgery within 8 weeks prior to the Screening Visit.
- •14. Participant is pregnant, breastfeeding, or planning to become pregnant during the 90-day treatment period.
- •15. Participant, parent, or legal guardian are unlikely to comply with the study procedures.
- •16. Participant has other medical, or psychological, or behavioral conditions that, in the opinion of the Investigator, would: confound or interfere with evaluation of safety, efficacy, and/or PK of the investigational drug; prevent compliance with the study protocol; preclude informed consent; or,render the participant, parent, or legal guardian unable/unlikely to comply with the study procedures.
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