Safety and Efficacy of Andecaliximab in Participants With... | NCT02405442

ID	Type	Description	Link
2015-001249-10	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Andecaliximab 150 mg Every 2 Weeks	Experimental	Double-Blind Phase: Participants will receive 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.	Drug: Andecaliximab Drug: Placebo
Andecaliximab 150 mg Weekly	Experimental	Double-Blind Phase: Participants will receive 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.	Drug: Andecaliximab Drug: Placebo
Andecaliximab 300 mg Weekly	Experimental	Double-Blind Phase: Participants will receive 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Andecaliximab	Drug	Andecaliximab administered via subcutaneous (SC) injection	Andecaliximab 150 mg Every 2 Weeks Andecaliximab 150 mg Weekly Andecaliximab 300 mg Weekly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase	Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.	Week 8
Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase	Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase	Clinical remission was defined as Crohn's Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Ability to provide a written informed consent
Females of childbearing potential must have a negative pregnancy test at screening and baseline
Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy
Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents:
- Corticosteroids
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Vedolizumab
May be receiving the following drugs:
- Oral 5-aminosalicylate (5-ASA)
- Oral corticosteroid therapy
- Antidiarrheals for chronic diarrhea
- Azathioprine or 6-mercaptopurine (6-MP) or methotrexate
- Antibiotics for the treatment of Crohn's disease
Able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements

Key Exclusion Criteria:

Evidence of abscess at screening
Extensive colonic resection (subtotal or total colectomy) or history of > 2 small bowel resections
Ileostomy, colostomy, or symptomatic stenosis of the intestine
Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone
Ulcerative colitis or indeterminate colitis
Short bowel syndrome
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with any monoclonal antibody within 4 weeks of screening
History or evidence of colonic mucosal dysplasia
HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection
Participated in a clinical study with an investigational drug or biologic within the last 30 days
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Name	Affiliation	Role
Gilead Study Team	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Health Specialists of The Southeast		Dothan	Alabama		United States
Mayo Clinic

PubMed Identifier	Type	Citation	Retractions
29846530	Result	Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.

ID	Title	Description
FG000	Andecaliximab 150 mg Every 2 Weeks	Double-Blind Phase: Participants received 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase

Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.

Full Analysis Set included all randomized participants who received at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab 150 mg Every 2 Weeks	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
OG001	Andecaliximab 150 mg Weekly	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
OG002	Andecaliximab 300 mg Weekly	Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
OG003	Placebo	Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Units	Counts
Participants	OG00053 OG00153 OG00253 OG003

Title

Denominators

Categories

Title	Measurements
	OG00017.0(8.1 to 29.8) OG00113.2(5.5 to 25.3) OG00211.3(4.3 to 23.0) OG003

Primary

Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase

Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab 150 mg Every 2 Weeks	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
OG001	Andecaliximab 150 mg Weekly	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Secondary

Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase

Clinical remission was defined as Crohn's Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab 150 mg Every 2 Weeks	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
OG001	Andecaliximab 150 mg Weekly	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Secondary

Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase

The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab 150 mg Every 2 Weeks	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
OG001	Andecaliximab 150 mg Weekly	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-Blind Andecaliximab 150 mg Every 2 Weeks (Q2W)	Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 1 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7.	53	1	53	15	53
EG001	Double-Blind Andecaliximab 150 mg Weekly (QW)	Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks.	53	6	53	25	53
EG002	Double-Blind Andecaliximab 300 mg Weekly	Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks.	53	8	53	25	53
EG003	Double-Blind Placebo	Adverse events reported in this group occurred during the Double-Blind Phase. Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks.	28	3	28	13	28
EG004	Open-Label Andecaliximab QW From Andecaliximab 150 mg Q2W	Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Every 2 Weeks group.	52	9	52	22	52
EG005	Open-Label Andecaliximab QW From Andecaliximab 150 mg QW	Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 150 mg Weekly group.	48	10	48	21	48
EG006	Open-Label Andecaliximab QW From Andecaliximab 300 mg QW	Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Andecaliximab 300 mg Every 2 Weeks group.	47	7	47	17	47
EG007	Open-Label Andecaliximab QW From Placebo	Adverse events reported in this group occurred during the Open-Label Phase in participants who received andecaliximab 150 mg weekly after switching from the Double-Blind Placebo group.	26	6	26	16	26

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk EG0021 affected53 at risk EG0030 affected28 at risk EG0040 affected52 at risk EG0050 affected48 at risk EG0060 affected47 at risk EG0071 affected26 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk EG0021 affected53 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0013 affected53 at risk EG0022 affected53 at risk EG003
Fistula of small intestine	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Ileal stenosis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk EG0020 affected53 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk EG0020 affected53 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Anal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Appendicitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk EG0020 affected53 at risk EG003
Acute prerenal failure	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0012 affected53 at risk EG0026 affected53 at risk EG0030 affected28 at risk EG0041 affected52 at risk EG0051 affected48 at risk EG0061 affected47 at risk EG0071 affected26 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0017 affected53 at risk EG0024 affected53 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0011 affected53 at risk EG0022 affected53 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected53 at risk EG0011 affected53 at risk EG0027 affected53 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected53 at risk EG0011 affected53 at risk EG0021 affected53 at risk EG003
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected53 at risk EG0010 affected53 at risk EG0025 affected53 at risk EG003
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0013 affected53 at risk EG0020 affected53 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0011 affected53 at risk EG0020 affected53 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected53 at risk EG0011 affected53 at risk EG0024 affected53 at risk EG003
Rhinitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0012 affected53 at risk EG0021 affected53 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0020 affected53 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0013 affected53 at risk EG0024 affected53 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0014 affected53 at risk EG0021 affected53 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected53 at risk EG0012 affected53 at risk EG0020 affected53 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0015 affected53 at risk EG0022 affected53 at risk EG003
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0014 affected53 at risk EG0025 affected53 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected53 at risk EG0010 affected53 at risk EG0021 affected53 at risk EG003

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Title	Description
BG000	Andecaliximab 150 mg Every 2 Weeks	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5 and 7. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
BG001	Andecaliximab 150 mg Weekly	Double-Blind Phase: Participants received 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
BG002	Andecaliximab 300 mg Weekly	Double-Blind Phase: Participants received 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
BG003	Placebo	Double-Blind Phase: Participants received 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label and Extended Treatment Phase: Participants received 1 single-use PFS of andecaliximab 150 mg administered weekly.
BG004	Total	Total of all reporting groups