Table 2.

Exploratory clinical outcomes at 28 days

Clinical parameter	Definition	Proportion meeting outcome [%]		Difference, 95% confidence interval [%]
		GB004	Placebo
Clinical response	Reduction in Mayo score of ≥ 3 points and ≥ 30% from baseline with accompanying decrease in rectal bleeding score ≥ 1 or absolute rectal bleeding score ≤ 1, among subjects with baseline rectal bleeding score > 0	30	18.2	11.8 [−24.9, 41.3]
Clinical remission	Mayo score ≤ 2, utilizing sigmoid endoscopic subscore among individuals with baseline sigmoid endoscopic subscore ≥ 1, with no individual subscore > 1	4.5	0	4.5 [−24.5, 23.3]
Resolution of rectal bleeding	Rectal bleeding subscore = 0, among subjects with baseline rectal bleeding subscore ≥ 1	57.1	36.4	20.8 [−18.4, 53.8]
Mucosal healing	Achieving improvement in endoscopic appearance and histological remission in same colonic segment	17.4	0	17.4 [−12.8, 38.8]
Histological remission	Sigmoid or rectum RHI score ≤ 3 with lamina propria neutrophils and neutrophils in epithelium subscores of 0 [among patients with corresponding baseline lamina propria and neutrophils in epithelium subscores > 0]	43.5	18.2	25.3 [−10.4, 53.5]
Endoscopic appearance improvement	Sigmoid or rectum endoscopic subscore ≤ 1 [if corresponding baseline endoscopic subscore > 1] or 0 [if corresponding baseline endoscopic subscore = 1]	17.4	18.2	0.8 [−34.5, 25.9]

MES, Mayo Endoscopic Score; RHI, Robarts Histopathology Index.