Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

• Sponsor: Arena Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02536404
• Collaborator: (none)
• Enrollment: 118
• Locations: 127
• Arms: 2
• Actual Duration (Months): 33.2
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Etrasimod; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
• Actual Study Start Date: Jan 25, 2016
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etrasimod 2 mg	Drug: Etrasimod; Other Names: APD334
Active Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) [Up to Week 48 (up to 30 days following discontinuation of the study drug)]

   A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.

Secondary Outcome Measures

1. Proportion of Participants Who Achieved Clinical Response [Week 46 (extension study APD334-005)]

   A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

2. Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005 [Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)]

   A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

3. Proportion of Participants Who Achieved Clinical Remission [Week 46 (extension study APD334-005)]

   A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

4. Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005 [Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)]

   A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants who completed the APD334-003 (NCT02447302) study

Exclusion Criteria:

• Participants who did not complete the APD334-003 study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arena 1119	Birmingham	Alabama	United States	35294
2	Arena 1133	Dothan	Alabama	United States	36305
3	Arena 1143	Thousand Oaks	California	United States	91360
4	Arena 1107	Hollywood	Florida	United States	33021
5	Arena 1138	Miami	Florida	United States	33134
6	Arena 1123	Naples	Florida	United States	34102
7	Arena 1141	Orlando	Florida	United States	32825
8	Arena 1106	Port Orange	Florida	United States	32127
9	Arena 1137	Sweetwater	Florida	United States	33172
10	Arena 1131	Chicago	Illinois	United States	60611
11	Arena 1139	Hoffman Estates	Illinois	United States	60169
12	Arena 1127	Urbana	Illinois	United States	61801
13	Arena 1113	Chevy Chase	Maryland	United States	20815
14	Arena 1142	Traverse City	Michigan	United States	49686
15	Arena 1111	Troy	Michigan	United States	48098
16	Arena 1109	Great Neck	New York	United States	11021
17	Arena 1114	Rochester	New York	United States	14642
18	Arena 1118	Raleigh	North Carolina	United States	27612
19	Arena 1112	Cincinnati	Ohio	United States	45267
20	Arena 1117	Pittsburgh	Pennsylvania	United States	15219
21	Arena 1105	Germantown	Tennessee	United States	38138
22	Arena 1102	Hermitage	Tennessee	United States	37076
23	Arena 1136	DeSoto	Texas	United States	75115
24	Arena 1121	Houston	Texas	United States	77030
25	Arena 1116	Temple	Texas	United States	76508
26	Arena 1103	Ogden	Utah	United States	84405
27	Arena 1130	Richmond	Virginia	United States	23298
28	Arena 1128	Roanoke	Virginia	United States	24014
29	Arena 1115	Seattle	Washington	United States	98101
30	Arena 1101	Seattle	Washington	United States	98195
31	Arena 1108	Wauwatosa	Wisconsin	United States	53226
32	Arena 1604	Kingswood		Australia	2747
33	Arena 1605	Randwick		Australia	2031
34	Arena 1607	Subiaco		Australia	6008
35	Arena 1490	Wien		Austria	1090
36	Arena 1472	Edegem		Belgium	2650
37	Arena 1464	Kortrijk		Belgium	8500
38	Arena 1473	Leuven		Belgium	3000
39	Arena 1421	Ruse		Bulgaria	1407
40	Arena 1417	Sofia		Bulgaria	1407
41	Arena 1410	Sofia		Bulgaria	1527
42	Arena 1409	Sofia		Bulgaria	1784
43	Arena 1407	Sofia		Bulgaria	1797
44	Arena 1425	Varna		Bulgaria	9010
45	Arena 1202	Winnipeg	Manitoba	Canada	R3A 1R9
46	Arena 1210	Bridgewater	Nova Scotia	Canada	B4V 3N2
47	Arena 1206	London	Ontario	Canada	N6A 4G5
48	Arena 1208	Sudbury	Ontario	Canada	P3E 1H5
49	Arena 1209	Sudbury	Ontario	Canada	P3E 6C3
50	Arena 1204	Toronto	Ontario	Canada	M5G 1X5
51	Arena 1455	Praha 4		Czechia	140 59
52	Arena 1443	Amiens Cedex 1		France	80054
53	Arena 1418	Clichy		France	92110
54	Arena 1437	Lille Cedex 1443		France	59037
55	Arena 1476	Paris		France	75010
56	Arena 1480	Pierre-Benite		France	693110
57	Arena 1423	Saint-Etienne Cedex 1		France	42055
58	Arena 1457	Vandoeuvre-les-Nancy		France	54511
59	Arena 1479	Hamburg		Germany	20249
60	Arena 1422	Hamburg		Germany	22559
61	Arena 1470	Hanover		Germany	30625
62	Arena 1446	Kiel		Germany	24105
63	Arena 1489	Leipzig		Germany	04103
64	Arena 1497	Oldenburg		Germany	26123
65	Arena 1444	Ulm		Germany	89073
66	Arena 1478	Bekescsaba		Hungary	5600
67	Arena 1431	Budapest		Hungary	1036
68	Arena 1471	Budapest		Hungary	1062
69	Arena 1492	Budapest		Hungary	1062
70	Arena 1505	Debrecen		Hungary	4025
71	Arena 1474	Debrecen		Hungary	4032
72	Arena 1477	Szombathely		Hungary	9700
73	Arena 1705	Beer Sheva		Israel	84101
74	Arena 1702	Haifa		Israel	31096
75	Arena 1706	Holon		Israel	58100
76	Arena 1704	Jerusalem		Israel	91031
77	Arena 1703	Petah-Tikva		Israel	49100
78	Arena 1615	Wonju	Gangwon-do	Korea, Republic of	26426
79	Arena 1614	Daegu		Korea, Republic of	42415
80	Arena 1610	Incheon		Korea, Republic of	21565
81	Arena 1462	Riga		Latvia	1002
82	Arena 1475	Riga		Latvia	1006
83	Arena 1484	Vilnius		Lithuania	8661
84	Arena 1601	Christchurch		New Zealand	8011
85	Arena 1439	Bydgoszcz		Poland	85-681
86	Arena 1486	Elblag		Poland	82-300
87	Arena 1495	Kielce		Poland	25-364
88	Arena 1451	Krakow		Poland	31-009
89	Arena 1438	Lodz		Poland	90-302
90	Arena 1458	Poznań		Poland	60-856
91	Arena 1428	Rzeszow		Poland	35-068
92	Arena 1456	Sopot		Poland	81-756
93	Arena 1494	Wroclaw		Poland	54-144
94	Arena 1491	Bucharest		Romania	010719
95	Arena 1406	Bucharest		Romania	020125
96	Arena 1441	Bucharest		Romania	050098
97	Arena 1436	Iasi		Romania	700506
98	Arena 1420	Oradea		Romania	410159
99	Arena 1405	Timisoara		Romania	300002
100	Arena 1493	Timisoara		Romania	300736
101	Arena 1500	Krasnoyarsk		Russian Federation	660022
102	Arena 1504	Novosibirsk		Russian Federation	630091
103	Arena 1419	Rostov-on-Don		Russian Federation	344022
104	Arena 1498	Saint Petersburg		Russian Federation	191015
105	Arena 1448	Saint Petersburg		Russian Federation	191186
106	Arena 1465	Samara		Russian Federation	443063
107	Arena 1403	Barcelona		Spain	08022
108	Arena 1460	Barcelona		Spain	08036
109	Arena 1481	Madrid		Spain	28046
110	Arena 1430	Pontevedra		Spain	36071
111	Arena 1432	Santiago de Compostela		Spain	15706
112	Arena 1469	Sevilla		Spain	41071
113	Arena 1424	Chernivtsi		Ukraine	03110
114	Arena 1445	Ivano-Frankivsk		Ukraine	76018
115	Arena 1454	Kharkov		Ukraine	06100
116	Arena 1459	Kharkov		Ukraine	61039
117	Arena 1466	Kiev		Ukraine	01030
118	Arena 1411	Kiev		Ukraine	04201
119	Arena 1408	Kyiv		Ukraine	01030
120	Arena 1506	Kyiv		Ukraine	02091
121	Arena 1414	Odessa		Ukraine	65025
122	Arena 1433	Uzhgorod		Ukraine	88018
123	Arena 1501	Vinnytsia		Ukraine	21029
124	Arena 1416	Vinnytsya		Ukraine	21018
125	Arena 1302	London		United Kingdom	E1 1BB
126	Arena 1304	Torquay		United Kingdom	TQ2 7AA
127	Arena 1303	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Arena Pharmaceuticals

Investigators

• Study Director: Arena CT.gov Administrator, Arena Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Apr 3, 2017
• Statistical Analysis Plan - Nov 27, 2018

More Information

Additional Information:

• Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study

Publications

None provided.

• Responsible Party: Arena Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02536404
• Other Study ID Numbers: APD334-005
• First Posted: Aug 31, 2015
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

Participant Flow

Arm/Group Title	Etrasimod 2 mg	Placebo
Arm/Group Description	Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Period Title: Overall Study
STARTED	112	6
COMPLETED	92	5
NOT COMPLETED	20	1

Baseline Characteristics

Arm/Group Title	Etrasimod 2 mg	Placebo	Total
Arm/Group Description	Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.	Total of all reporting groups
Overall Participants	112	6	118
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.7 (13.25)	50.2 (13.93)	44.0 (13.30)
Sex: Female, Male (Count of Participants)
Female	44 39.3%	3 50%	47 39.8%
Male	68 60.7%	3 50%	71 60.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 3.6%	0 0%	4 3.4%
Not Hispanic or Latino	108 96.4%	6 100%	114 96.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 3.6%	0 0%	4 3.4%
Native Hawaiian or Other Pacific Islander	1 0.9%	0 0%	1 0.8%
Black or African American	1 0.9%	0 0%	1 0.8%
White	104 92.9%	6 100%	110 93.2%
More than one race	1 0.9%	0 0%	1 0.8%
Unknown or Not Reported	1 0.9%	0 0%	1 0.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Description	A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Time Frame	Up to Week 48 (up to 30 days following discontinuation of the study drug)

Outcome Measure Data

Analysis Population Description

Safety Population: All randomized participants who received study medication in the extension study APD334-005

Arm/Group Title	Etrasimod 2 mg	Placebo
Arm/Group Description	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Measure Participants	112	6
TEAEs	67 59.8%	5 83.3%
Treatment-emergent SAEs	7 6.3%	0 0%

2. Secondary Outcome

Title	Proportion of Participants Who Achieved Clinical Response
Description	A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame	Week 46 (extension study APD334-005)

Outcome Measure Data

Analysis Population Description

Completers Population Evaluable Cohort: All participants who received at least 1 dose of etrasimod or placebo and completed the extension study APD334-005

Arm/Group Title	Etrasimod 2 mg	Placebo
Arm/Group Description	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Measure Participants	84	4
Number (90% Confidence Interval) [Percentage of participants]	78.6 70.2%	75.0 1250%

3. Secondary Outcome

Title	Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005
Description	A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame	Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

Outcome Measure Data

Analysis Population Description

Completers Population Evaluable Cohort

Arm/Group Title	Etrasimod 2 mg	Placebo
Arm/Group Description	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Measure Participants	84	4
Number (90% Confidence Interval) [Percentage of participants]	39.3 35.1%	50.0 833.3%

4. Secondary Outcome

Title	Proportion of Participants Who Achieved Clinical Remission
Description	A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame	Week 46 (extension study APD334-005)

Outcome Measure Data

Analysis Population Description

Completers Population Evaluable Cohort

Arm/Group Title	Etrasimod 2 mg	Placebo
Arm/Group Description	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Measure Participants	84	4
Number (90% Confidence Interval) [Percentage of participants]	39.3 35.1%	25.0 416.7%

5. Secondary Outcome

Title	Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005
Description	A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.
Time Frame	Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

Outcome Measure Data

Analysis Population Description

Completers Population Evaluable Cohort

Arm/Group Title	Etrasimod 2 mg	Placebo
Arm/Group Description	Participants received etrasimod 2 mg tablet by mouth, once daily for 34 weeks in fasted state.	Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
Measure Participants	84	4
Number (90% Confidence Interval) [Percentage of participants]	14.3 12.8%	0 0%

Adverse Events

Time Frame	Up to Week 48 (up to 30 days following discontinuation of the study drug)
Adverse Event Reporting Description	A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.
Arm/Group Title	Etrasimod 2 mg		Placebo
Arm/Group Description	Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.		Participants received matching placebo tablet by mouth, once daily for 34 weeks in fasted state.
All Cause Mortality
	Etrasimod 2 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/6 (0%)
Serious Adverse Events
	Etrasimod 2 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/112 (6.3%)		0/6 (0%)
Blood and lymphatic system disorders
Iron deficiency anaemia	2/112 (1.8%)		0/6 (0%)
Cardiac disorders
Atrial fibrillation	1/112 (0.9%)		0/6 (0%)
Gastrointestinal disorders
Colitis ulcerative	3/112 (2.7%)		0/6 (0%)
Large intestine perforation	1/112 (0.9%)		0/6 (0%)
Pancreatitis	1/112 (0.9%)		0/6 (0%)
Proctitis ulcerative	1/112 (0.9%)		0/6 (0%)
Infections and infestations
Gastroenteritis	1/112 (0.9%)		0/6 (0%)
Nervous system disorders
Fine motor skill dysfunction	1/112 (0.9%)		0/6 (0%)
Transient ischaemic attack	1/112 (0.9%)		0/6 (0%)
Renal and urinary disorders
Cystitis haemorrhagic	1/112 (0.9%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Etrasimod 2 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/112 (58.9%)		5/6 (83.3%)
Blood and lymphatic system disorders
Anaemia	10/112 (8.9%)		0/6 (0%)
Neutropenia	3/112 (2.7%)		0/6 (0%)
Endocrine disorders
Hyperparathyroidism	0/112 (0%)		1/6 (16.7%)
Eye disorders
Vitreous	0/112 (0%)		1/6 (16.7%)
Gastrointestinal disorders
Colitis ulcerative	16/112 (14.3%)		1/6 (16.7%)
Nausea	5/112 (4.5%)		1/6 (16.7%)
Dental caries	0/112 (0%)		1/6 (16.7%)
Gastritis	0/112 (0%)		1/6 (16.7%)
Glossodynia	0/112 (0%)		1/6 (16.7%)
Large intestine polyp	0/112 (0%)		1/6 (16.7%)
Infections and infestations
Nasopharyngitis	6/112 (5.4%)		2/6 (33.3%)
Upper respiratory tract infection	7/112 (6.3%)		0/6 (0%)
Gastroenteritis	3/112 (2.7%)		0/6 (0%)
Bronchitis	0/112 (0%)		1/6 (16.7%)
Chronic sinusitis	0/112 (0%)		1/6 (16.7%)
Herpes zoster	1/112 (0.9%)		1/6 (16.7%)
Influenza	1/112 (0.9%)		1/6 (16.7%)
Tooth infection	0/112 (0%)		1/6 (16.7%)
Investigations
Gamma-glutamyltransferase increased	10/112 (8.9%)		0/6 (0%)
Aspartate aminotransferase increased	3/112 (2.7%)		0/6 (0%)
Faecal calprotectin increased	3/112 (2.7%)		1/6 (16.7%)
Hepatic enzyme increased	3/112 (2.7%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
Back pain	4/112 (3.6%)		2/6 (33.3%)
Musculoskeletal chest pain	0/112 (0%)		1/6 (16.7%)
Nervous system disorders
Headache	5/112 (4.5%)		0/6 (0%)
Carpal tunnel syndrome	1/112 (0.9%)		1/6 (16.7%)
Reproductive system and breast disorders
Premenstrual headache	0/112 (0%)		1/6 (16.7%)
Skin and subcutaneous tissue disorders
Rash	0/112 (0%)		1/6 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.