GM-CSF as a therapeutic target in autoimmune diseases

Table 1 Clinical trials targeting GM-CSF

Target	Drug	Indication	Trial	Phase	Regimen	Status
GM-CSFR	Mavrilimumab (CAM-3001)	RA	NCT00771420	I	MTX + 0.01, 0.03, 0.1, 0.3, 1.0, 3.0, and 10.0 mg/kg or placebo, single dose	Completed	[121]
		RA	NCT01050998 (EARTH study)	IIa	MTX + 10, 30, 50, and 100 mg or placebo biweekly for 12 weeks	Completed	[117]
		RA	NCT01706926 (EARTH EXPLORER 1)	IIb	MTX + 30, 100, and 150 mg or placebo biweekly for 24 weeks	Completed	[122–125]
		RA	NCT01712399	IIb	Long time safety study (5 years) MTX + 100 mg biweekly	Active, not recruiting	[126, 127]
		RA	NCT01715896 (EARTH EXPLORER 2)	II	MTX + mavrilimumab biweekly or golimumab alternating with placebo	Completed	[128]
GM-CSF	MOR103	RA	NCT01023256	Ib/IIa	0.3, 1.0, and 1.5 mg/kg or placebo weekly for 4 weeks	Completed	[116]
GM-CSF	MOR103	MS	NCT01517282	Ib	0.5, 1.0, and 2.0 mg/kg or placebo biweekly for 10 weeks	Completed	[115]
GM-CSF	Namilumab (MT203)	RA	NCT01317797	Ib	150 and 300 mg or placebo biweekly, 3 times	Completed	[129]
		RA	NCT02393378	II	MTX + namilumab or adalimumab for 24 weeks	Recruiting	[131]
		RA	NCT02379091	II	MTX + 20, 80, and 150 mg or placebo for 24 weeks	Recruiting	[130]
		Psoriasis	NCT02129777	II	40, 100, 160, and 300 mg or placebo on day 1; 20, 50, 80, and 150 mg or placebo on days 15, 43, and 71 (followed by open-label extension study)	Recruiting	[132]
GM-CSF	KB003	RA	NCT00995449	II	600 mg or placebo at weeks 0, 2, 4, 8, and 12	Terminated	[133]
GM-CSF	KB003	Asthma	NCT01603277	II	400 mg or placebo	Completed
GM-CSF	MORAb-022	RA	NCT01357759	I	Escalating doses of MORAb-022 or placebo	Completed	[134]

Abbreviations: GM-CSFR GM-CSF receptor, RA rheumatoid arthritis, MS multiple sclerosis, MTX methotrexate

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