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Table 4 Summary of the efficacy data proof of concept phase IIa study

From: Biomarkers can predict potential clinical responders to DIMS0150 a toll-like receptor 9 agonist in ulcerative colitis patients

  ITT population (n = 34)
  Placebo (n = 12) DIMS0150 (n = 22) P value
Clinical response 1    
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 remission 2    
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 response 3    
Wk4 0 (0%) 6 (27%) 0.06
Sustained histological response:   
Wk4 and wk12 0/8 (0%) 3/16 (19%) 0.2
Histological remission 4    
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
  1. 1defined as DAI score decrease of at least 3 points from baseline.
  2. 2defined as a total DAI score of 2 points or lower, with no individual sub-score exceeding 1 point.
  3. 3defined as histology score decrease of at least 3 points from baseline.
  4. 4defined as histology score decrease to a score of zero.
  5. No wk24 data of patients with sustained remission available.
  6. (ITT) Intention-To-Treat; P values calculated with Fisher’s Exact Test for response/remission rates.