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) - BO42451/ Crosswalk-C

Roche Nederland B.V.0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- Signed ICF
•- Age >= 12 to <= 55 years
•- Body weight >= 40 kg
•- Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell
•anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia)
•- Two or more (>= 2) to <=10 documented VOEs in the 12 months prior to
•randomization
•- If receiving concurrent SCD-directed therapy, the patient must have been on a
•stable dose for a minimum of 3 months prior to study enrollment. 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
•- Vaccination against N. meningitides serotypes A, C, W and Y
•- Vaccinations against H. influenza type B and S. pneumonia
•- Patients who have been vaccinated (partially or in full) against SARSCoV-2
•with a locally approved vaccine are eligible to be enrolled in the study, 3
•days or longer after inoculation
•- Adequate hepatic and renal function
•- For women of childbearing potential, agreement to remain abstinent or use
•contraception during the treatment period and for 46 weeks (approximately 10.5
•months) after the final dose of study treatment

•- History of hematopoietic stem cell transplant
•- Participating in a chronic transfusion program and/or planning on undergoing
•an exchange transfusion during the duration of the study
•- History of hypersensitivity, allergic, or anaphylactic reactions to any
•ingredient contained in the study treatment
•- 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
•- Hemoglobin <6 g/dL
•- Known or suspected hereditary complement deficiency
•- Active systemic bacterial, viral, or fungal infection within 14 days before
•first drug administration
•- Presence of fever (>= 38 degrees Celsius) 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
•- Known HIV infection with documented CD4 count <200 cells/microliter within 24
•weeks prior to screening
•- History of N. meningitidis infection within the prior 6 months

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