LBCTR2021064791招募中3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso-occlusive Crises
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
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 90（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSß0
- •thalassemia, or HbSß+ thalassemia genotype).
- •Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing
- •during Screening.
- •2. Participant is male or female, = 12 years of age at the time of informed
- •NOTE: Initial study enrollment will include participants = 16 years of age until the DMC determines that adequate safety and PK data support the
- •enrollment of participants 12 to 15 years of age. Sites will be informed by the Sponsor when participants 12 to 15 years of age may be enrolled.
- •3. Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history.
- •A prior VOC is defined as an acute episode of pain which:
- •- Has no medically determined cause other than a vaso-occlusive event,
- •- Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or
- •results in a remote contact with a healthcare provider; and
- •- Requires parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral
- •4. Participants receiving erythropoiesis-stimulating agents (ESA, erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
- •5. Participants receiving HU, L-glutamine, or voxelotor (Oxbryta) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to
- •continue with the stabilized regimen throughout the course of the study.
- •6. Participant has adequate venous access, in the opinion of the Investigator, to comply with study procedures.
- •7. Participant understands the study procedures and agrees to participate in the study by giving written informed consent or parental permission/written assent.
- •8. 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
- •Exclusion Criteria
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at
- •Screening or Baseline visits or at the timepoint specified in the individual criterion listed.
- •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 the Screening Visit.
- •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 during Screening.
- •7. Participant has a history of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including severe or unstable pulmonary hypertension.
- •8. Participant has had treatment for a malignancy within the 12 months prior to the Screening Visit (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 an 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 in another investigational trial within 30 days or 5 half-lives of the investigational agent (whichever is greater) prior to the Screening Visit.
- •13. 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 48-week treatment period.
- •15. Participant, parent, or legal guardian are unlikely to comply with the study procedures.
- •16. Participant has other medical, psychological, or addictive condition 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 caretaker unable/unlikely to
- •comply with the study procedures.
研究者
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