A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD)

Crohn’s disease, Ulcerative colitis

1.Clinical remission is a modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1, where a score of 1 does not include “friability”., 2. Endoscopic response defined as a reduction in Simple Endoscopic Score for Crohn’s Disease (SES CD) of at least 50% from baseline.

1.In patients with moderate to severe UC: Clinical response at week 14, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1., 2. In patients with moderate to severe UC: Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1 at week 14. Endoscopic remission defined as a Mayo endoscopic subscore of 0 at week 14. Clinical response defined as decrease from baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency) at week 14. Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale at week 14., 3.In patients with moderate to severe CD are as follows: Clinical response defined as a ≥100-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline at weeks 4, 8, 12 and 14. Clinical remission defined as a CDAI score <150 at week 14., 4.In patients with moderate to severe CD are as follows:-Clinical response defined as a decrease from baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency) at week 14., 5.In patients with moderate to severe CD are as follows: Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale at week 14. Endoscopic response defined as a decrease in modified multiplier (MM)-SES-CD of >50% from baseline at week 14., 6. Safety and tolerability measures/parameters: Adverse events; Change from baseline in clinical laboratory test results (serum chemistry, hematology, and urinalysis)., 7. Safety and tolerability measures/parameters: Change from baseline in vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate); Change from baseline in 12-lead electrocardiogram (ECG) findings; Patients who stopped the IMP due to adverse events; Local tolerability at the injection site., 8.Immunogenicity endpoints:-Change from baseline in treatment-emergent anti-drug antibody (ADA) at weeks 2, 4, 8, 14, and follow-up visit.-Presence of neutralizing ADA in ADA positive patients at weeks 2, 4, 8, 14, and follow-up visit.

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