Clinical Study
Recombinant T-Cell Receptor Ligand (RTL) for Treatment of Multiple Sclerosis: A Double-Blind, Placebo-Controlled, Phase 1, Dose-Escalation Study
Table 1
Baseline demographics and clinical characteristics.
| | Characteristic | Placebo | 2 mg | 6 mg | 20 mg | 60 mg | 200 mg | 100 mg | Total | | () | () | () | () | () | () | () | () |
| | Female- (%) | 8 (73) | 4 (100) | 5 (71) | 3 (75) | 4 (100) | 2(67) | 0 | 26 (76) | | White-not hispanic or Latino- | 11 | 4 | 7 | 4 | 4 | 3 | 1 | 34 |
| | Age mean (SD) | 52.0 (8.18) | 54.3 (2.16) | 53.0 (6.30) | 58.5 (6.44) | 55.9 (7.04) | 50.3 | 38.8 | 53.2 | | RRMS (%) | 2 (18) | 2 (50) | 2 (29) | 1 (25) | 1 (25) | 2 (67) | 1(100) | 11 (32) |
| | SPMS (%) | 9 (82) | 2 (50) | 5 (71) | 3 (75) | 3 (75) | 1 (33) | 0 (0) | 23 (68) |
| | Number of relapses in the past year (SD) | 0.6 (0.81) | 0.3 (0.50) | 1.0 (1.15) | 0.5 (0.58) | 0.0 (0.00) | 0.3 (0.47) | 1 | |
| | Time since diagnosis years-mean (SD) | 14.5 (10.87) | 13.2 (6.04) | 13.5 (9.02) | 12.1 (6.26) | 19.6 (9.42) | 7.3 (6.34) | 2 | |
| | Time since last relapse months-mean (SD) | 58 (89.5) | 42 (48.0) | 48 (68.2) | 69 (97.5) | 77 (38.4) | 32 (26.4) | 9 | |
| | HLA DR2 homozygous (%) | 0 | 1 (25) | 2 (29) | 1 (25) | 0 | 1 (33) | 0 | 5 (15) |
| | EDSS score (min, max) | 5.41 (3.0, 7.0) | 3.38 (2.0, 4.0) | 5.71 (3.0, 6.5) | 5.00 (4.0, 6.0) | 4.88 (3.0, 6.5 | 3.87 (2.5, 6.0) | 2.5 | |
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