Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302)

INTERVENTION: Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti‐MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti‐MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] Ulcerative Colitis ; MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670 PRIMARY OUTCOME: Main Objective: The primary objective of the study is to evaluate the efficacy of SHP647 in inducing remission,based on composite score of patient‐reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC). Primary end point(s): The primary efficacy endpoint is the proportion of subjects in remission at the Week 12 visit. Remission is defined as a composite score of patient‐reported symptoms using daily e‐diary and centrally read endoscopy as follows:; • stool frequency subscore of 0 or 1 with at least a 1‐point change from baseline; AND; • rectal bleeding subscore of 0; AND; • endoscopic subscore of 0 or 1 (modified, excludes friability). Secondary Objective: To evaluate the efficacy of SHP647 in achieving endoscopic remission, based on centrally read endoscopy.; • To evaluate the efficacy of SHP647 in achieving clinical remission, based on composite score of patient‐reported symptoms.; • To evaluate the efficacy of SHP647 in inducing clinical response, based on composite score of patient‐reported symptoms and centrally read endoscopy.; • To evaluate the efficacy of SHP647 in achieving mucosal healing, based on endoscopic and histological assessment. Timepoint(s) of evaluation of this end point: Week 12 visit SECONDARY OUTCOME: Secondary end point(s): • Proportion of subjects with endoscopic remission, as defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability), at the Week 12 visit. ; • Proportion of subjects with clinical remission, as defined by stool frequency subscore of 0 or 1 with at least a 1‐point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0, at the Week 12 visit. ; • Proportion of subjects with clinical response based on composite score at the Week 12 visit. Clinical response (composite) is defined as a decrease from baseline in the composite score of patient‐reported symptoms using daily e‐diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding =1 point or a subscore for rectal bleeding =1. ; • Proportion of subjects with mucosal healing based on endoscopic and histological assessment at the Week 12 visit. Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of =2. ; Timepoint(s) of evaluation of this end point: Week 12 visit INCLUSION CRITERIA: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Subjects must be between =16 and =80 years of age at the time of the signing of the informed consent/assent form. NOTE: Subjects <18 years of age must weigh =40 kg and must have body mass index (BMI) =16.5. 2. Subjects must have a documented diagnosis (radiologic or endoscopic with histology) of UC for =3 months before screening. The following must be available in each subject’s source documentation: • A biopsy report to confirm the histological diagnosis. • A report documenting disease duration based upon prior colonoscopy. NOTE: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period. 3. Subjects must be willing to undergo a flexible sigmoidoscopy or colonoscopy (if preferred), including biopsy sample collection, during screenin