Table 4.
Summary of the efficacy data proof of concept phase IIa study
| |
ITT population (n = 34) |
||
|---|---|---|---|
| Placebo (n = 12) | DIMS0150 (n = 22) | P value | |
|
Clinical response1 |
|
|
|
| Week 1 (wk1) |
2 (17%) |
7 (32%) |
0.43 |
| Week 4 (wk4) |
4 (33%) |
9 (41%) |
0.71 |
|
Sustained clinical response: |
|
|
|
| Wk1 and wk4 |
0/12 (0%) |
6/22 (27%) |
0.06 |
|
Clinical remission2 |
|
|
|
| Wk1 |
1 (8%) |
2 (9%) |
1.0 |
| Wk4 |
0 (0%) |
3 (13%) |
0.27 |
|
Sustained clinical remission: |
|
|
|
| Wk1 and wk4 |
0/12 (0%) |
2/22 (9%) |
0.18 |
|
Histological response3 |
|
|
|
| Wk4 |
0 (0%) |
6 (27%) |
0.06 |
|
Sustained histological response: |
|
|
|
| Wk4 and wk12 |
0/8 (0%) |
3/16 (19%) |
0.2 |
|
Histological remission4 |
|
|
|
| Wk4 |
0 (0%) |
6 (27%) |
0.06 |
|
Sustained histological remission: |
|
|
|
| Wk4 and wk12 |
0/8 (0%) |
3/16 (19%) |
0.2 |
|
Clinical response paralleled with histological remission |
|
|
|
| Wk4 | 0/4 (0%) | 4/9 (44%) | 0.22 |
1defined as DAI score decrease of at least 3 points from baseline.
2defined as a total DAI score of 2 points or lower, with no individual sub-score exceeding 1 point.
3defined as histology score decrease of at least 3 points from baseline.
4defined as histology score decrease to a score of zero.
No wk24 data of patients with sustained remission available.
(ITT) Intention-To-Treat; P values calculated with Fisher’s Exact Test for response/remission rates.