Table 5.
Clinical trials of monoclonal antibodies targeting GM-CSF in rheumatoid arthritis
| Drug | Clinical trials status (trial registration number) |
Clinical trial design | References |
|---|---|---|---|
| KB003 | Phase II terminated (NCT00995449) |
Randomized, placebo-controlled, dose-ranging trial investigating five IV infusions of KB003 (70, 20, 0 or 600 mg doses) at weeks 0, 2, 4, 8, and 12 in patients with active RA and inadequate response to prior biologic therapy. Safety evaluation was performed at 14 and 30 weeks | 69 |
| MORAb-002 | Phase I completed (NCT01357759) |
Randomized, double-blind, placebo-controlled, single-dose trial investigating dose- escalation of IV MORAb-022 for safety and tolerability evaluation in patients with RA | 70 |
| MOR103 | Phase Ib/IIa published (NCT01023256) |
Randomized, multicenter, double-blind, placebo-controlled trial investigating weekly dose-escalation of IV MOR103 (0.3, 1.0, or 1.5 mg/kg) with follow-up to 16 weeks, for safety evaluation in RA patients | 71 |
| Namilumab | Phase I completed (NCT02354599) |
Randomized, single-center, double-blind, placebo-controlled trial investigating SC administration of single dose of namilumab (80, 150, and 300 mg) for safety and pharmacokinetics evaluations in healthy subjects | 72 |
| Phase Ib completed (NCT01317797) |
Randomized, double-blind, placebo-controlled trial investigating three SC injections of dose-escalating namilumab (150 and 300 mg) plus MTX with 12 weeks’ follow-up for safety and tolerability evaluation in patients with active RA | 73 | |
| Phase II ongoing not recruiting (NCT02379091) |
Randomized, double-blind, placebo-controlled trial investigating three SC doses of namilumab (20, 80, and 150 mg) plus MTX with 24 weeks’ follow-up for efficacy and safety evaluation in patients with active RA and inadequate response to MTX and antitumor necrosis factor inhibitors | 74 | |
| Phase II ongoing not recruiting (NCT02393378) |
Randomized, open-label, parallel-group, active-controlled trial investigating SC injections of namilimumab 300 mg at week 0 followed by 150 mg eow or adalimumab 40 mg eow, plus MTX. Efficacy evaluation at 24 weeks with magnetic resonance imaging scan for changes in synovitis, erosion, and bone marrow edema (osteitis) from baseline | 75 |
Abbreviations: eow, every other week; GM-CSF, granulocyte-macrophage colony-stimulating factor; IV, intravenous; MTX, methotrexate; RA, rheumatoid arthritis; SC, subcutaneous.