Administered orally

Clinical remission is defined as a mMCS of ≤ 2, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability).The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

Clinical remission is defined as a mMCS of ≤ 2, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability). The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

Histologic-endoscopic mucosal improvement is a composite endpoint that uses different units of measure for histologic and endoscopic activities.Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils & eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Histologic-endoscopic mucosal improvement is defined as achieving both Geboes score ≤ 3.1 and endoscopic subscore ≤ 1

Mucosal healing is a composite endpoint that uses different units of measure for histologic and endoscopic activities. Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils & eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Mucosal healing is defined as achieving both Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.

Endoscopic improvement is defined as an endoscopic subscore of ≤ 1. Endoscopic subscore is a part of the modified Mayo Clinic Score which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration).

Partial mMCS remission is defined as a SFS ≤ 1 and rectal bleeding subscore of 0.