Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: Itolizumab: Itolizumab is presented as a sterile; white to pale yellow; preservative-free lyophilised cake in single-use 6R LYO (lyophilisation) glass vials stoppered with LYO stoppers and sealed with flip-off seals. Reconstitution with 1.1 mL of sterile water for injection (SWFI) yields a solution containing 100 mg/mL of itolizumab. It is administered as single dose of 1.6 mg/kg given as an Intravenous (IV) infusion on Day 1. The infusion must be initiated at 25 mL/h for the first hour. If well tolerated it can be increased to 50 mL/h to infuse the remaining amount. The infusion is to be completed over 6 hours.Control Intervention1: Placebo: The Placebo is presented as a sterile; colourless to pale yellow preservative-free solution in identical glass vials as the test drug.The single infusion of placebo will be administered. infusion will be initiated at 25 mL/h for the first hour. If well tolerated it can be increased to 50 mL/h to infuse the remaining amount. The infusion is to be completed over 6 hours.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: Itolizumab: Itolizumab is presented as a sterile; white to pale yellow; preservative-free lyophilised cake in single-use 6R LYO (lyophilisation) glass vials stoppered with LYO stoppers and sealed with flip-off seals. Reconstitution with 1.1 mL of sterile water for injection (SWFI) yields a solution containing 100 mg/mL of itolizumab. It is administered as single dose of 1.6 mg/kg given as an Intravenous (IV) infusion on Day 1. The infusion must be initiated at 25 mL/h for the first hour. If well tolerated it can be increased to 50 mL/h to infuse the remaining amount. The infusion is to be completed over 6 hours.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Control Intervention1: Placebo: The Placebo is presented as a sterile; colourless to pale yellow preservative-free solution in identical glass vials as the test drug.The single infusion of placebo will be administered. infusion will be initiated at 25 mL/h for the first hour. If well tolerated it can be increased to 50 mL/h to infuse the remaining amount. The infusion is to be completed over 6 hours.", "treatment_type": "Placebo", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 691, "treatment_name": "Itolizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]