PACTR202106511293049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
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 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 consent.
- •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 narcotics.
- •4. Participants receiving erythropoiesis-stimulating agents
- •(ESA, eg, 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 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
- •1. Participant is receiving regularly scheduled 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
- •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 active malaria infection at
- •Screening. Testing to be conducted at local laboratories in malariaendemic
- •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
- •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, or 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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