Table 3.
Summary of clinical trials for new drugs in clinical development for moderate-to-severe Crohn’s disease.
| Drug (route of administration) | Study reference | Study phase | Primary endpoint | Drug dose (No. of patients) | % of patients who achieved the primary endpoint |
|---|---|---|---|---|---|
| Abrilumab (s.c.) | Sandborn et al., 2017a | 2b | Induction of clinical remission at week 8, defined as CDAI < 150 points | 21 mga (26) | 23.1 |
| 70 mga (84) | 14.4 | ||||
| 210 mgb (41) | 21.9 | ||||
| Placebo (98) | 12.8 | ||||
| AJM300 (p.o) | Takazoe et al., 2009 | 2 | Clinical response evaluated by means of the mean decrease of CDAI (±SD) from baseline at week 4 or later | 40 mg three times daily (NA)c | 19.9 ± 74.1 |
| 120 mg three times daily (NA)c | 25.5 ± 61.3 | ||||
| 240 mg three times daily (NA)c | 21.6 ± 84.9 | ||||
| Placebo (NA)c | 5.2 ± 71 | ||||
| PF-00547659 (s.c.) | Sandborn et al., 2015 | 2 | Clinical response at week 12, defined as reduction of CDAI ≥ 70 points | 22.5 mgd (67) | 62 |
| 75 mgd (64) | 65 | ||||
| 225 mgd (68) | 58 | ||||
| Placebo (63) | 59 | ||||
| Risankizumab (i.v.) | Feagan et al., 2016c | 2 | Induction of clinical remission at week 12, defined as CDAI < 150 points | 200 mgd (41) | 24.4 |
| 600 mgd (41) | 36.6∗ | ||||
| Placebo (39) | 15.4 | ||||
| Brazikumab (i.v.) | Sands et al., 2015 | 2a | Clinical response at week 8, defined as reduction of CDAI ≥ 100 points | 700 mge (57) | 49.2∗ |
| Placebo (55) | 26.7 | ||||
| PF-04236921 (s.c.) | Danese et al., 2016 | 2 | Clinical response at week 12, defined as reduction of CDAI ≥ 70 points | 10 mge (65) | 35.2 |
| 50 mge (68) | 47.4∗ | ||||
| Placebo (69) | 28.6 | ||||
| Filgotinib (p.o) | Vermeire et al., 2017a | 2 | Induction of clinical remission at week 10, defined as CDAI < 150 points | 200 mg once daily (128) | 48∗ |
| Placebo (44) | 23 | ||||
| Mongersen (p.o) | Monteleone et al., 2015 | 2 | Induction of clinical remission at day 15, defined as CDAI < 150 points | 10 mg once daily (41) | 22 |
| 40 mg once daily (40) | 65∗ | ||||
| 160 mg once daily (43) | 55∗ | ||||
| Placebo (42) | 10∗ | ||||
∗p < 0.05; CDAI, Crohn’s disease activity index; SD, standard deviation; NA, not available; p.o, per os (oral); s.c., subcutaneous; i.v., intravenous; aat week 0, 2, and 4, and then every 4 weeks; bsingle dose; ctotal number of patients: 71; dat week 0, 4, and 8; eat week 0 and 4.