Safety and Efficacy of Andecaliximab (GS-5745) in Adults... | NCT02520284

ID	Type	Description	Link
2014-005217-24	EudraCT Number

Label	Type	Description	Intervention Names
Andecaliximab Every 2 Weeks	Experimental	Participants will receive andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.	Biological: Andecaliximab Biological: Placebo
Andecaliximab Weekly	Experimental	Participants will receive andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.	Biological: Andecaliximab
Placebo	Placebo Comparator	Participants will receive placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Based on Week 8 assessment results, participants will either continue in Blinded Maintenance Treatment phase or will be offered Open-Label andecaliximab 150 mg administered via SC injection weekly for up to Week 51.	Biological: Andecaliximab Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Andecaliximab	Biological	Andecaliximab 150 mg administered via SC injection	Andecaliximab Every 2 Weeks Andecaliximab Weekly Placebo

Measure	Description	Time Frame
For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8	EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).	Week 8

Measure	Description	Time Frame
For Cohort 1, Percentage of Participants With MCS Remission at Week 8	The MCS was 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), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The MCS remission was defined as a MCS of ≤ 2 points and no individual subscore > 1 point. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

ID	Title	Description
FG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via subcutaneous (SC) injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission and/or Mayo Clinical Score (MCS) response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

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Anticipated Posting Date

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Dispersion Type

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Calculate Percentage

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Units Analyzed

Denominator Units Selected

Arm/Group Information

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Analyses

Primary

For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8

EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).

Full Analysis Set included all randomized participants who received at least 1 dose of study drug in the Blinded Induction Phase (Cohort 1).

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
OG001	Andecaliximab Weekly	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
OG002	Placebo	Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.

Units	Counts
Participants	OG00054 OG00156 OG00255

Title

Denominators

Categories

Title	Measurements
	OG0007.4(2.1 to 17.9) OG0011.8(0.0 to 9.6) OG0027.3(2.0 to 17.6)

Secondary

For Cohort 1, Percentage of Participants With MCS Remission at Week 8

The MCS was 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), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The MCS remission was defined as a MCS of ≤ 2 points and no individual subscore > 1 point. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Secondary

For Cohort 1, Percentage of Participants With MCS Response at Week 8

The MCS was 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), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening. The MCS response was defined as a MCS reduction of ≥ 3 points and at least 30% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Secondary

For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8

Endoscopic remission was defined as endoscopic subscore of 0. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
OG001	Andecaliximab Weekly	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Secondary

For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8

Endoscopic response was defined as endoscopic subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
OG001	Andecaliximab Weekly	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.

Secondary

For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8

Mucosal healing was defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. When measured by the Geboes histologic scoring system, it was the selection of the following combined scores of ≤ 3 for Grade 0 (Structural Architectural Change), ≤ 1 for Grade 1 (Chronic Inflammatory Infiltrate), ≤ 3 for Grade 2A (Lamina Propria Eosinophils), and 0 for Grade 2B (Lamina Propria Neutrophils), Grade 3 (Neutrophils in Epithelium), Grade 4 (Crypt Destruction), and Grade 5 (Erosion or Ulceration). Total Geboes histologic score ranged from 0 to 22, with higher scores indicating greater disease severity.

Participants in the Full Analysis Set who did not meet the mucosal healing definition at baseline were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Secondary

For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8

The MCS remission (alternative definition) was defined as a rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA subscore (range: 0 to 3 with higher score indicating the severe disease) of 0, and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]) of 0 or 1 for an overall MCS of ≤ 1. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.

Participants in the Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Blinded Induction Phase: Andecaliximab Every 2 Weeks	Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab.	54	0	54	24	54
EG001	Blinded Induction Phase: Andecaliximab Every Weeks	Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses.	56	2	56	31	56
EG002	Blinded Induction Phase: Placebo	Adverse events reported in this group occurred during the Blinded Induction Phase. Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses.	55	1	55	26	55
EG003	Blinded Maintenance Phase: Andecaliximab Every 2 Weeks	Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks.	20	1	20	12	20
EG004	Blinded Maintenance Phase: Andecaliximab Every Week	Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks.	16	2	16	12	16
EG005	Blinded Maintenance Phase: Placebo	Adverse events reported in this group occurred during the Blinded Maintenance Phase. Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks.	18	1	18	13	18
EG006	Open-Label Maintenance Phase From Andecaliximab Every 2 Weeks	Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.	32	1	32	9	32
EG007	Open-Label Maintenance Phase From Andecaliximab Every Week	Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.	35	3	35	6	35
EG008	Open-Label Maintenance Phase From Placebo	Adverse events reported in this group occurred during the Open-Label Maintenance Phase. Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.	34	2	34	12	34

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected54 at risk EG0014 affected56 at risk EG0022 affected55 at risk EG0033 affected20 at risk EG0041 affected16 at risk EG0050 affected18 at risk EG0060 affected32 at risk EG0071 affected35 at risk EG0083 affected34 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Dry eye	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0021 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0012 affected56 at risk EG0025 affected55 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected54 at risk EG0013 affected56 at risk EG0021 affected55 at risk EG003
Dyschezia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected54 at risk EG0012 affected56 at risk EG0020 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected54 at risk EG0013 affected56 at risk EG0023 affected55 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0011 affected56 at risk EG0023 affected55 at risk EG003
Feeling hot	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Influenza like illness	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Injection site bruising	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0014 affected56 at risk EG0020 affected55 at risk EG003
Injection site erythema	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Injection site hypersensitivity	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Peripheral swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0014 affected56 at risk EG0021 affected55 at risk EG003
Thirst	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Folliculitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0021 affected55 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected54 at risk EG0012 affected56 at risk EG0022 affected55 at risk EG003
Rhinitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0013 affected56 at risk EG0020 affected55 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected54 at risk EG0012 affected56 at risk EG0020 affected55 at risk EG003
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0022 affected55 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0022 affected55 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0014 affected56 at risk EG0021 affected55 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0013 affected56 at risk EG0023 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0013 affected56 at risk EG0022 affected55 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0022 affected55 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0021 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected54 at risk EG0014 affected56 at risk EG0021 affected55 at risk EG003
Lethargy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Sciatica	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Menstrual disorder	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0013 affected56 at risk EG0021 affected55 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0021 affected55 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0012 affected56 at risk EG0020 affected55 at risk EG003
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected54 at risk EG0010 affected56 at risk EG0020 affected55 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0021 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected54 at risk EG0011 affected56 at risk EG0020 affected55 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Dothan	Alabama		United States

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Title	Description
BG000	Andecaliximab Every 2 Weeks	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for a total of 4 doses of andecaliximab. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection alternating with matching placebo weekly for up to approximately 40 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 41 weeks.
BG001	Andecaliximab Weekly	Blinded Induction Phase: Participants received andecaliximab 150 mg administered via SC injection once weekly for a total of 8 doses. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive andecaliximab 150 mg administered via SC injection once weekly for up to approximately 33 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 34 weeks.
BG002	Placebo	Blinded Induction Phase: Participants received placebo matched to andecaliximab administered via SC injection once weekly for a total of 8 doses. Blinded Maintenance Phase: Participants who achieved EBS clinical remission and/or MCS response, based on Week 8 assessments, continued to receive placebo matched to andecaliximab administered via SC injection once weekly for up to approximately 39 weeks. Open-Label Maintenance Phase: Participants who achieved neither EBS clinical remission nor MCS response, based on Week 8 assessments, were offered open-label andecaliximab 150 mg administered via SC injection once weekly for up to approximately 38 weeks.
BG003	Total	Total of all reporting groups