Table 2.
Summary of clinical trials for new drugs in clinical development for moderate-to-severe ulcerative colitis.
| Drug (route of administration) | Study reference | Study phase | Primary endpoint | Drug dose (No. of patients) | % of patients who achieved the primary endpoint |
|---|---|---|---|---|---|
| Ozanimod (p.o) | Sandborn et al., 2016b | 2 | Induction of clinical remission at week 8, defined as FMS ≤ 2 | 0.5 mg once daily (65) | 13.8 |
| 1 mg once daily (67) | 16.4∗ | ||||
| Placebo (65) | 6.2 | ||||
| Sandborn et al., 2016b | 2 | Maintenance of clinical remission at week 32, defined as FMS ≤ 2 | 0.5 mg once daily (65) | 26.2∗ | |
| 1 mg once daily (67) | 20.9∗ | ||||
| Placebo (67) | 6.2 | ||||
| Abrilumab (s.c.) | Sandborn et al., 2017b | 2b | Induction of clinical remission at week 8, defined as FMS ≤ 2 | 7 mga (21) | 1.6 |
| 21 mga (40) | 2.9 | ||||
| 70 mga (98) | 13.5∗ | ||||
| 210 mgb (79) | 13.4∗ | ||||
| Placebo (116) | 4.4 | ||||
| AJM300 (p.o) | Yoshimura et al., 2015 | 2 | Clinical response at week 8, defined as decrease of at least three points and 30% of FMS from baseline | 960 mg three times daily (51) | 62.7∗ |
| Placebo (51) | 25.5 | ||||
| Etrolizumab (s.c.) | Vermeire et al., 2014 | 2 | Induction of clinical remission at week 10, defined as FMS ≤ 2 | 100 mgc (39) | 21∗ |
| 420/300 mgd (39) | 10∗ | ||||
| Placebo (41) | 0 | ||||
| PF-00547659 (s.c.) | Reinisch et al., 2015 | 2 | Induction of clinical remission at week 12, defined as FMS ≤ 2 | 7.5 mgc (NA)e | 11.3∗ |
| 22.5 mgc (NA) | 16.7∗ | ||||
| 75 mgc (NA) | 15.5∗ | ||||
| 225 mgc (NA) | 5.7 | ||||
| Placebo (NA) | 2.7 | ||||
| Tofacitinib (p.o) | Sandborn et al., 2016c | 3 | Induction of clinical remission at week 8, defined as FMS ≤ 2 | 10 mg twice daily (905)f | 18∗ |
| Placebo (234)f | 8.2 | ||||
| Sandborn et al., 2017d | 3 | Maintenance of clinical remission at week 52, defined as FMS ≤ 2 | 5 mg twice daily (198) | 34.3∗ | |
| 10 mg twice daily (197) | 40.3∗ | ||||
| Placebo (198) | 11.1 | ||||
∗p < 0.05; FMS, Full Mayo Score; 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; cat week 0, 4, and 8; d420 mg at week 0, and then 300 mg at week 2, 4, and 8; etotal number of patients: 357; fOCTAVE 1 + OCTAVE 2.