| ITT population (n = 34) | ||
---|---|---|---|
 | Placebo (n = 12) | DIMS0150 (n = 22) | P value |
Clinical response 1 | Â | Â | Â |
Week 1 (wk1) | 2 (17%) | 7 (32%) | 0.43 |
Week 4 (wk4) | 4 (33%) | 9 (41%) | 0.71 |
Sustained clinical response: | Â | Â | Â |
Wk1 and wk4 | 0/12 (0%) | 6/22 (27%) | 0.06 |
Clinical remission 2 | Â | Â | Â |
Wk1 | 1 (8%) | 2 (9%) | 1.0 |
Wk4 | 0 (0%) | 3 (13%) | 0.27 |
Sustained clinical remission: | Â | Â | Â |
Wk1 and wk4 | 0/12 (0%) | 2/22 (9%) | 0.18 |
Histological response 3 | Â | Â | Â |
Wk4 | 0 (0%) | 6 (27%) | 0.06 |
Sustained histological response: | Â | Â | |
Wk4 and wk12 | 0/8 (0%) | 3/16 (19%) | 0.2 |
Histological remission 4 | Â | Â | Â |
Wk4 | 0 (0%) | 6 (27%) | 0.06 |
Sustained histological remission: | Â | Â | |
Wk4 and wk12 | 0/8 (0%) | 3/16 (19%) | 0.2 |
Clinical response paralleled with histological remission | Â | Â | Â |
Wk4 | 0/4 (0%) | 4/9 (44%) | 0.22 |