At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND)
In Brief
A Phase 3 clinical trial evaluating Crizanlizumab (SEG101) and Placebo for Sickle Cell Disease (SCD). Active but no longer recruiting, targeting 255 participants across 59 sites in 21 countries.
Signals
Detailed Summary
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.
Study Details
Timeline
Arms & Interventions
Participants received Crizanlizumab (SEG101) at 5.0 mg/kg
Participants received Crizanlizumab (SEG101) at 7.5 mg/kg
Participants received the placebo drug.
Interventions
Crizanlizumab was supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for infusion. IV.
Placebo was supplied in single use 10 mL glass vials at a concentration of 0 mg/mL. This is a concentrate for solution for infusion IV.