Trial Outcomes & Findings for Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) (NCT NCT02522780)

Last Updated: 2021-11-08

Results Overview

The proportion of subjects with remission was defined by Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0 (normal) to 9 (severe disease), higher scores indicating greater disease severity. The score included clinical response component to assess subject's symptoms and endoscopic response component to assess objective evidence of inflammation. Clinical response component had two subscales: stool frequency ranging from 0 (normal number of stools) to 3 (\>=5 stools more than normal) and rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes). The Endoscopic response component had one subscale: flexible sigmoidoscopy/colonoscopy ranging from 0 (normal) to 3 (severe disease). Data is presented cumulative for all pathways.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

276 participants

Primary outcome timeframe

Month 6

Results posted on

2021-11-08

Participant Flow

A total of 50 sites in 10 countries randomized subjects to this trial between February 2016 to April 2018, the last subject completed last visit in September 2018. Of 403 subjects screened, 276 subjects were randomized in a 1:1 ratio to either mesalamine or placebo group (138 subjects each), for 6 months.

Of 276 subjects, (a) 53 were rolled-over from Trial 000174 (NCT02522767) who achieved remission after 8-weeks double-blind treatment with placebo (Pathway 1a; 4 subjects) or mesalamine (Pathway 1b; 10 subjects), or an additional 8-weeks open-label treatment with mesalamine (Pathway 2; 39 subjects), and (b) 223 subjects were de novo (Pathway 3).

Participant milestones

Participant milestones
Measure	Mesalamine Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.	Placebo Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Overall Study STARTED	138	138
Overall Study Treated	137	135
Overall Study Intention-to-treat (ITT) Population	136	136
Overall Study COMPLETED	121	111
Overall Study NOT COMPLETED	17	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Mesalamine Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.	Placebo Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Overall Study Consent withdrawn by subject	5	7
Overall Study Protocol deviation	1	3
Overall Study Subject refused endoscopic procedure	0	1
Overall Study Adverse event, non-fatal	11	16

Baseline Characteristics

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.	Total n=272 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants	126 Participants n=7 Participants	256 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	41.5 years STANDARD_DEVIATION 13.50 • n=5 Participants	45.2 years STANDARD_DEVIATION 13.65 • n=7 Participants	43.4 years STANDARD_DEVIATION 13.67 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	77 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	59 Participants n=7 Participants	125 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants	127 Participants n=7 Participants	257 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	130 Participants n=7 Participants	260 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	24.56 kg/m^2 STANDARD_DEVIATION 4.812 • n=5 Participants	24.89 kg/m^2 STANDARD_DEVIATION 4.657 • n=7 Participants	24.73 kg/m^2 STANDARD_DEVIATION 4.729 • n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: The ITT analysis set included all randomized subjects who were assigned to mesalamine 4 g extended release granules in Trial 000174 (NCT02522767) (Pathway 1b) or randomized via Pathways 2 or 3.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Proportion of Subjects With Remission at Month 6	82 Participants	67 Participants

SECONDARY outcome

Timeframe: Month 2, 4, and 6

The proportion of subjects in clinical remission was defined as a score of 0 for rectal bleeding and 0 or 1 for stool frequency based on clinical response score component of the Clinical and Endoscopic Response Score. Clinical response score component had two subscales to assess subject's symptoms: rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes) and stool frequency ranging from 0 (normal number of stools) to 3 (\>=5 stools more than normal). The scores of clinical response component ranged from 0 (normal) to 6 (severe disease), higher scores indicating greater disease severity. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Proportion of Subjects in Clinical Remission at Month 2, 4, and 6 Month 2	122 Participants	116 Participants
Proportion of Subjects in Clinical Remission at Month 2, 4, and 6 Month 4	113 Participants	113 Participants
Proportion of Subjects in Clinical Remission at Month 2, 4, and 6 Month 6	96 Participants	89 Participants

SECONDARY outcome

Timeframe: Time from randomization to the day of withdrawal due to escalation of therapy (up to 6 months)

Time to relapse was defined as the number of days from randomization to the day of withdrawal due to escalation of therapy. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Time to Relapse	NA days Median and 95% confidence interval (CI) was not estimable due to insufficient events to meet the threshold for 50% on the Kaplan-Meier curve.	NA days Median and 95% CI was not estimable due to insufficient events to meet the threshold for 50% on the Kaplan-Meier curve.

SECONDARY outcome

Timeframe: Month 6

The proportion of subjects with an increase from baseline in the Clinical and Endoscopic Response Score by 2 or more points in at least 1 component, or by 1 or more points in at least 2 components were reported. The Clinical and Endoscopic Response Score ranged between 0 (normal) to 9 (severe disease), higher scores indicating greater disease severity. The score included clinical response component to assess subject's symptoms and endoscopic response component to assess objective evidence of inflammation. Clinical Response component had two subscales: stool frequency ranging from 0 (normal number of stools) to 3 (\>=5 stools more than normal) and rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes). The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy ranging from 0 (normal) to 3 (severe disease). Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Proportion of Subjects With an Increase From Baseline in the Clinical and Endoscopic Response Score by 2 or More Points in at Least 1 Component or by 1 or More Points in at Least 2 Components at Month 6	14 Participants	30 Participants

SECONDARY outcome

Timeframe: Baseline, Month 2, 4, and 6

The adjusted mean change from baseline in serum CRP levels at Month 2, 4, and 6 were reported. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6 Month 2	0.8 mg/L Standard Deviation 4.76	2.2 mg/L Standard Deviation 15.63
Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6 Month 4	1.0 mg/L Standard Deviation 5.69	0.9 mg/L Standard Deviation 5.53
Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6 Month 6	0.8 mg/L Standard Deviation 3.67	2.5 mg/L Standard Deviation 16.66

SECONDARY outcome

Timeframe: Baseline, Month 2, 4, and 6

The adjusted mean change from baseline in fecal calprotectin levels at Month 2, 4, and 6 were reported. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6 Month 2	-94.8 mcg/g Standard Deviation 553.00	12.8 mcg/g Standard Deviation 509.70
Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6 Month 4	-41.7 mcg/g Standard Deviation 533.02	53.6 mcg/g Standard Deviation 581.64
Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6 Month 6	-43.5 mcg/g Standard Deviation 553.13	36.4 mcg/g Standard Deviation 559.98

SECONDARY outcome

Timeframe: Baseline, Month 2, 4, and 6

The IBDQ is an instrument used to assess quality of life in adult subjects with ulcerative colitis. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Subjects were asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). The total IBDQ was computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better HRQOL. The adjusted mean change from baseline at Month 2, 4, and 6 for the IBDQ total scores were reported. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=136 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=136 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6 Month 2	-1.3 points on a score Standard Deviation 17.78	-0.4 points on a score Standard Deviation 20.00
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6 Month 4	-0.6 points on a score Standard Deviation 20.40	-0.3 points on a score Standard Deviation 18.53
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6 Month 6	-0.5 points on a score Standard Deviation 24.80	-1.2 points on a score Standard Deviation 23.44

SECONDARY outcome

Timeframe: Up to Month 6

Population: The analysis was based on safety analysis set which included all subjects who received at least 1 dose of IMP.

An AE is defined as any untoward medical occurrence in a subject participating in a clinical trial. Any AEs includes serious as well as non-serious AEs. An SAE is defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect, or was an important medical event. Any AE which occurred in the time interval from initial dosing (investigational medicinal product \[IMP\] intake) to the end of treatment visit (Month 6) was considered treatment-emergent. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=137 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=135 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Any Treatment-Emergent AEs	42 Participants	49 Participants
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Treatment-Emergent SAEs	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Month 6

Population: The analysis was based on safety analysis set.

The number of subjects with intensity of AEs (classified as mild, moderate or severe) were presented. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=137 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=135 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Severity of Adverse Events Mild	32 Participants	32 Participants
Severity of Adverse Events Moderate	18 Participants	22 Participants
Severity of Adverse Events Severe	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The analysis was based on safety analysis set. Here, 'Number Analyzed' signifies number of subjects with available data at specified category for each arm, respectively.

Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. Criteria for markedly abnormal laboratory (Hematology): Basophils/Leukocytes: \>=5%, Eosinophils/Leukocytes: \>=10%, Erythrocytes: \<=3.5\*10\^6/μL, Hematocrit: \<=0.32%; \>=0.56%, Hemoglobin: \<=11.5 g/dL, Leukocytes: \<=2.8\*10\^3/μL; \>=16.0\*10\^3/μL, Lymphocytes/Leukocytes: \<=10%; \>=80%, Monocytes/Leukocytes: \>=20%, Neutrophils/Leukocytes: \<=15%; \>=90%, Platelets: \<=75\*10\^3/μL; \>=700\*10\^3/μL. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=137 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=135 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Hemoglobin: <=11.5 g/dL	29 Participants	23 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Basophils/Leukocytes: >=5%	0 Participants	1 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Eosinophils/Leukocytes: >=10%	3 Participants	7 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Erythrocytes: <=3.5*10^6/μL	2 Participants	1 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Hematocrit: <=0.32%	1 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Hematocrit: >=0.56%	8 Participants	12 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Leukocytes: <=2.8*10^3/μL	4 Participants	4 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Leukocytes: >=16.0*10^3/μL	2 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Lymphocytes/Leukocytes: <=10%	3 Participants	4 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Lymphocytes/Leukocytes: >=80%	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Monocytes/Leukocytes: >=20%	0 Participants	1 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Neutrophils/Leukocytes: <=15%	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Neutrophils/Leukocytes: >=90%	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Platelets: <=75*10^3/μL	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology Platelets: >=700*10^3/μL	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The analysis was based on safety analysis set. Here, 'Number Analyzed' signifies number of subjects with available data at specified category for each arm, respectively.

Proportion of subjects with markedly abnormal changes from baseline in coagulation values are presented. Criteria for markedly abnormal laboratory (coagulation): Activated Partial Thromboplastin Time (aPTT): \>70 seconds (sec), Prothrombin International Normalized Ratio (INR): \<0.8; \>1.1. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=137 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=135 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation aPTT: >70 sec	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation Prothrombin INR: <0.8	0 Participants	2 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation Prothrombin INR: >1.1	46 Participants	54 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The analysis was based on safety analysis set. Here, 'Number Analyzed' signifies number of subjects with available data at specified category for each arm, respectively.

Proportion of subjects with markedly abnormal changes from baseline in serum chemistry values are presented. Criteria for markedly abnormal laboratory (serum chemistry): Alanine Aminotransferase (ALT): \>3\*upper limit of normal (ULN), Alkaline Phosphatase (ALP): \>3\*ULN and 25% increase (inc) from baseline (BL), Aspartate Aminotransferase (AST): \>3\* ULN, Bilirubin: \>=1.5\* ULN, Blood Urea Nitrogen: \>=10.7 mg/dL, Calcium: \<=1.8 mg/dL; \>=3.9 mg/dL, Chloride: \<=90 mmol/L; \>=115 mmol/L, Creatinine: \>=177 mg/dL, Gamma Glutamyl Transferase: \>3\*ULN, Glomerular Filtration Rate (GFR): \<30 mL/min, Glucose: \<=2.8 mg/dL; \>=10 mg/dL, Potassium: \<=3.0 mmol/L; \>=5.8 mmol/L, Sodium: \<=130 mmol/L; \>=155 mmol/L. Data is presented cumulative for all pathways.

Outcome measures

Outcome measures
Measure	Mesalamine n=137 Participants Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo. n=135 Participants Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry ALT: >3*ULN	1 Participants	1 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Blood Urea Nitrogen: >=10.7 mg/dL	8 Participants	11 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Calcium: <=1.8 mg/dL	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Calcium: >=3.9 mg/dL	9 Participants	12 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Chloride: <=90 mmol/L	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Chloride: >=115 mmol/L	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Creatinine: >=177 mg/dL	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Gamma Glutamyl Transferase: >3*ULN	6 Participants	4 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry GFR: <30 mL/min	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Glucose: <=2.8 mg/dL	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Glucose: >=10 mg/dL	11 Participants	14 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Potassium: <=3.0 mmol/L	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Potassium: >=5.8 mmol/L	0 Participants	2 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Sodium: <=130 mmol/L	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Sodium: >=155 mmol/L	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry ALP: >3*ULN & 25% inc from BL	0 Participants	0 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry AST: >3*ULN	2 Participants	2 Participants
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry Bilirubin: >=1.5*ULN	8 Participants	5 Participants

Adverse Events

Mesalamine

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mesalamine n=137 participants at risk Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo n=135 participants at risk Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Vascular disorders Hypertension	0.73% 1/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.00% 0/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Cardiac disorders Acute myocardial infarction	0.73% 1/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.00% 0/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Infections and infestations Ecthyma	0.00% 0/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Infections and infestations Pneumonia	0.00% 0/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Infections and infestations Sepsis	0.00% 0/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.

Other adverse events

Other adverse events
Measure	Mesalamine n=137 participants at risk Mesalamine 2 g extended release granules (sachet), administered orally QD for 6 months.	Placebo n=135 participants at risk Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Investigations Glomerular filtration rate decreased	0.73% 1/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	3.7% 5/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Investigations Alanine aminotransferase increased	2.9% 4/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Investigations Gamma-glutamyltransferase increased	2.9% 4/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Investigations Faecal calprotectin increased	2.2% 3/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Gastrointestinal disorders Colitis ulcerative	10.2% 14/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	14.8% 20/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Infections and infestations Respiratory tract infection viral	2.2% 3/137 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.	0.74% 1/135 • Up to Month 6 Treatment-Emergent AEs were defined as AEs which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

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