Table 1.

Crizanlizumab Clinical Trials.^14,16-18

National clinical trial identifier	Trial name	Enrollment status	Study phase/trial type	Patient ages	Primary outcome measures	Select secondary outcome measures
NCT01895361	SUSTAIN	Completed13,14	Phase 2, randomized, placebo-controlled, double-blind	16 to 65 years	Annual rate of sickle cell-related pain crises	Health care visit data, sickle cell-related pain crisis data, and acute chest syndrome rates
NCT03264989	SOLACE-adults	Active, not recruiting	Phase 2, open-label	16 to 70 years	PK and PD measurements	VOC rates and events, health care visit data
NCT03474965	SOLACE-kids	Recruiting	Phase 2, open-label	6 months to <18 years	PK, PD, and safety measurements	VOC rates, health care visit data, adverse events, hemoglobin, growth/sexual maturity, anti-drug antibodies, and PK profiles
NCT03814746	STAND	Recruiting	Phase 3, randomized, placebo-controlled, double-blind	≥12 years	Rate of VOC events leading to health care visit	Health care visit data, PK profiles, hemoglobin, growth/sexual maturity, and anti-drug antibodies
NCT03938454	SPARTAN	Recruiting	Phase 2, open-label	Males ≥16 years	Percent change in priapic events from baseline	Priapic event rates, VOC data
NCT04053764	STEADFAST	Recruiting	Phase 2, randomized, open-label	≥16 years	Percentage of patients with ≥30% decrease in albuminuria	Albuminuria, protein to creatinine ratio, estimated glomerular filtration rate, anti-drug antibodies, PK profiles, and health care visit data
Not available	SUCCESSOR	Ongoing 15	Retrospective, non-interventional follow-up study of adult patients in SUSTAIN	≥18 years	Evaluate outcomes related to sickle cell disease	Evaluate outcomes related to sickle cell disease
NCT04662931	—	Not yet recruiting	Phase 4, open-label	≥16 years	Serious adverse events	Adverse events
NCT04657822	—	Not yet recruiting	Phase 4, open-label, rollover	Any age; rollover from previous studies	Adverse events	—

Abbreviations: PK, pharmacokinetic; PD, pharmacodynamic; VOC, vaso-occlusive crisis.