Safety and Efficacy Study of JNJ-64304500 in Participants... | NCT02877134

ID	Type	Description	Link
64304500CRD2001	Other Identifier	Janssen Research & Development, LLC
2016-000634-21	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part I : Placebo	Experimental	Participants will receive placebo Subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. From Week 12 Placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) or CDAI <150) will continue to receive placebo SC injections every 2 weeks from Week 12 through Week 22. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 400 mg SC at Week 12 and then JNJ-64304500 200 mg every two weeks from Week 14 through Week 22.	Drug: JNJ-64304500 Drug: Placebo
Part I : JNJ-64304500	Experimental	Participants will receive JNJ-64304500 400 milligram (mg) SC at Week 0 then 200 mg SC every two weeks through Week 22.	Drug: JNJ-64304500
Part II : Placebo	Experimental	Placebo SC at Weeks 0, 2, 4, and 8. From Week 12, placebo-treated participants who are in clinical response at Week 12 (>=100-point reduction from baseline in CDAI or CDAI <150) will continue to receive placebo at Weeks 12, 14, 16, and 20. Placebo -treated participants who are not in clinical response at Week 12 will receive JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg at Weeks 14, 16, and 20. Participants who complete Part II 24 weeks assessment and may benefit from continued treatment in the opinion of the investigator are eligible to enter the Part II LTE in which they will continue to receive placebo up to 52 weeks (for a total of up to 72 weeks of placebo in Part II). The study has been unblinded due to lack of sufficient efficacy of JNJ- 64304500. Participants receiving placebo during the LTE will stop receiving placebo.	Drug: JNJ-64304500 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
JNJ-64304500	Drug	Participants will receive JNJ-64304500 Subcutaneously.	Part I : JNJ-64304500 Part I : Placebo Part II : JNJ-64304500 High Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8	The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	Baseline to Week 8
Part II: Change From Baseline in the CDAI Score at Week 12	The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)	Clinical Remission was defined as a CDAI score of <150 point. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0
Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified: a) Oral 5-aminosalicylic acid (5-ASA) compounds, b) Oral corticosteroids at a prednisone-equivalent dose at or below 40 milligram per day (mg/day), or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate, c) Antibiotics being used as a primary treatment of Crohn's disease, d) Conventional immunomodulators (that is, azathioprine (AZA), 6-mercaptopurine (6-MP), or Methotrexate (MTX)): participants must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline
A participant who has had extensive colitis for greater than or equal to (>=) 8 years, or disease limited to the left side of the colon for >= 12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy
Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 but <= 450

Exclusion Criteria:

Participants who have received intravenous (IV) corticosteroids less then (<)3 weeks or have received tumor necrosis factor-alpha (TNF-alpha) antagonist biologic agents (example, monoclonal antibody [mAb] therapies) or other agents intended to suppress or eliminate tumor necrosis factor-alpha (TNF-alpha) <8 weeks or have received Vedolizumab <16 weeks before the first administration of study drug
Woman who is pregnant or planning pregnancy or is a man who plans to father while randomized in the study or within 16 weeks after the last administration of study agent
Participants with certain complications of Crohn's disease that would make it hard to assess response to study drug
Participants with a history of or ongoing chronic or recurrent infectious disease
Has previously received a biologic agent targeting interleukin (IL)-12 or IL-23, including but not limited to ustekinumab or briakinumab (ABT-874)

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40357993	Derived	Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
36939629	Derived	Allez M, Sands BE, Feagan BG, D'Haens G, De Hertogh G, Randall CW, Zou B, Johanns J, O'Brien C, Curran M, Rebuck R, Wang ML, Sabins N, Baker T, Kobayashi T. A Phase 2b, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study Evaluating the Safety and Efficacy of Tesnatilimab in Patients with Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2023 Aug 21;17(8):1235-1251. doi: 10.1093/ecco-jcc/jjad047.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part I: Placebo	Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 4, 2021	Dec 10, 2021

Arm/Group Information

ID	Title	Description
BG000	Part I: Placebo	Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
BG001	Part I: JNJ-64304500	Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.
BG002	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
BG003	Part II: JNJ-64304500 Low Dose	Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
BG004	Part II: JNJ-64304500 Middle Dose	Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
BG005	Part II: JNJ-64304500 High Dose	Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
BG006	Part II: Ustekinumab	Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously [IV]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight [less than or equal to [<=] 55 kg). - Ustekinumab 390 mg (weight greater than [>] 55 kg and less than or equal to [<=] 85 kg). Ustekinumab 520 mg (weight >85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.](streamdown:incomplete-link)
BG007	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038.9± 13.3 BG00138± 13.25 BG00240.6± 13.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00031 BG00133 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

BELGIUM

Title	Measurements
	BG0000 BG0010 BG002

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

Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8

The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

The efficacy analyses were based on the Full analysis set (FAS) included all randomized participants in Part 1 who received at least 1 dose of study agent.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Week 8

ID	Title	Description
OG000	Part I: Placebo	Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 milligrams (mg) SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Participants were followed up for safety up to Week 38.
OG001	Part I: JNJ-64304500	Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. All participants were followed up for safety up to Week 38.

Units	Counts
Participants	OG00072 OG00173

Title

Denominators

Categories

Title	Measurements
	OG000-60.0± 77.08 OG001-103.6± 93.54

Primary

Part II: Change From Baseline in the CDAI Score at Week 12

The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to number of participants analyzed for this outcome measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
OG001

Secondary

Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150)

Clinical Remission was defined as a CDAI score of <150 point. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

FAS included all randomized participants in Part II who received at least 1 dose of study agent.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
OG001

Secondary

Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by CDAI (Greater Than or Equal to [>=] 100-point Reduction From Baseline in CDAI or CDAI <150)

Clinical response was defined as a >=100-point reduction from the baseline CDAI score, or a CDAI score <150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.

FAS included all randomized participants in Part II who received at least 1 dose of study agent.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.

Secondary

Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12

The PRO-2 score is defined as the sum of the abdominal pain and stool frequency components of the CDAI. PRO-2 scores ranges from 0 to approximately 300, higher score indicates higher disease activity.

FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to the number of participants analyzed for this outcome measure.

Posted

Mean

Standard Deviation

units on scale

Baseline, Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
OG001	Part II: JNJ-64304500 Low Dose	Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.

Secondary

Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75)

Clinical Remission was defined as a PRO-2 score of <75 point.

FAS included all randomized participants in Part II who received at least 1 dose of study agent.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
OG001	Part II: JNJ-64304500 Low Dose	Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.

Secondary

Part II: Percentage of Participants in Clinical Response at Week 12 as Measured by PRO-2 (>=50-point Reduction From Baseline in PRO-2 Score or PRO-2 Score <75)

Clinical response was defined as >=50-point reduction from baseline in PRO-2 or Score or PRO-2 Score <75.

FAS included all randomized participants in Part II who received at least 1 dose of study agent.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
OG001	Part II: JNJ-64304500 Low Dose	Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.

Secondary

Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was 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.

FAS included all randomized participants in Part II who received at least 1 dose of study agent. Here 'N' refers to number of participants analyzed for this outcome measure.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ-64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.
OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part I: Placebo	Participants received placebo subcutaneously (SC) at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo every 2 weeks (Q2W) through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data up to the time of receiving JNJ-64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants were followed up for safety up to Week 38.	0	72	1	72	24	72
EG001	Part I: Placebo to JNJ-64304500	Participants received placebo SC at Weeks 0, 2, 4, 6, 8, and 10. Participants in clinical response at Week 12 continued to receive placebo Q2W through Week 22. Participants not in clinical response at Week 12 received JNJ-64304500 400 mg SC at Week 12 and then 200 mg SC Q2W from Week 14 through Week 22. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants were followed up for safety up to Week 38.	0	44	2	44	10	44
EG002	Part I: JNJ-64304500	Participants received JNJ-64304500 400 mg SC at Week 0 then 200 mg SC every two weeks through Week 22. Participants were followed up for safety up to Week 38.	1	73	8	73	38	73
EG003	Part II: Placebo	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data up to the time of receiving JNJ- 64304500 for those who received JNJ-64304500 at Week 12 and included all data for those who did not receive JNJ-64304500 at Week 12. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II long term extension (LTE) phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.	0	48	3	48	16	48
EG004	Part II: Placebo to JNJ-64304500 Middle Dose	Participants received placebo SC at Weeks 0, 2, 4, and 8. Participants in clinical response at Week 12 continued to receive placebo at Weeks 12, 14, 16, and 20. Participants not in clinical response at Week 12 received JNJ 64304500 150 mg SC at Week 12 and then JNJ-64304500 75 mg SC at Weeks 14, 16, and 20. Safety results included data from the time of receiving JNJ- 64304500 at Week 12 onward. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.	0	31	0	31	6	31
EG005	Part II: JNJ-64304500 Low Dose	Participants received JNJ-64304500 50 mg SC at Week 0 and 25 mg SC at Weeks 2 and 4, then 25 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.	0	50	3	50	24	50
EG006	Part II: JNJ-64304500 Middle Dose	Participants received JNJ-64304500 150 mg SC at Week 0 and 75 mg SC at Weeks 2 and 4, then 75 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.	0	49	0	49	23	49
EG007	Part II: JNJ-64304500 High Dose	Participants received JNJ-64304500 400 mg SC at Week 0 and 200 mg SC at Weeks 2 and 4, then 200 mg SC every four weeks through Week 20. Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.	1	49	6	49	26	49
EG008	Part II: Ustekinumab	Participants received Ustekinumab (tiered doses approximating 6 milligrams/kilograms (mg/kg) intravenously [IV]) at Week 0 (as indicated in the bullets below), followed by 90 mg SC at Weeks 8 and 16. - Ustekinumab 260 mg (weight [less than or equal to [<=] 55 kg). - Ustekinumab 390 mg (weight greater than [>] 55 kg and less than or equal to [<=] 85 kg). Ustekinumab 520 mg (weight >85 kg). Participants who completed Part II Week 24 assessments and who were benefited from continued treatment, in the opinion of the investigator, were eligible to enter the Part II LTE phase at Week 24. Participants who did not enter into LTE phase at Week 24 were followed up for safety up to Week 36.](streamdown:incomplete-link)	0	47	2	47	20	47
EG009	Part II LTE: Placebo	Participants randomized to placebo group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received placebo at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.	0	10	1	10	5	10
EG010	Part II LTE: Placebo to JNJ-64304500 Middle Dose	Participants randomized to placebo group and had dose adjustment to JNJ-64304500 middle dose at Week 12 and continued to receive JNJ-64304500 middle dose (JNJ-64304500 75 mg) SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72 in the Part II LTE. Participants were followed up for safety up to Week 88.	0	12	3	12	5	12
EG011	Part II LTE: JNJ-64304500 Low Dose	Participants randomized to the 'JNJ-64304500 Low Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 25 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.	0	21	2	21	6	21
EG012	Part II LTE: JNJ-64304500 Middle Dose	Participants randomized to the 'JNJ-64304500 Middle Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 75 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.	0	27	5	27	12	27
EG013	Part II LTE: JNJ-64304500 High Dose	Participants randomized to the 'JNJ-64304500 High Dose' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received JNJ-64304500 200 mg SC at Weeks 24, 28, 32, 36, 40, 44, 48, 52 56, 60, 64, 68, and 72. Participants were followed up for safety up to Week 88.	0	24	5	24	10	24
EG014	Part II LTE: Ustekinumab	Participants randomized to the 'Ustekinumab' group and who were benefitted from continued treatment in the opinion of the investigator, entered the Part II LTE phase and received Ustekinumab 90 mg IV at Weeks 24, 32, 40, 48, 56, 64 and 72. Participants were followed up for safety up to Week 88.	0	28	5	28	9	28

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG0030 affected48 at risk EG0040 affected31 at risk EG0050 affected50 at risk EG0060 affected49 at risk EG0070 affected49 at risk EG0080 affected47 at risk EG0090 affected10 at risk EG0100 affected12 at risk EG0110 affected21 at risk EG0120 affected27 at risk EG0130 affected24 at risk EG0141 affected28 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Cardiac Arrest	Cardiac disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected44 at risk EG0025 affected73 at risk EG003
Ileal Perforation	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Ileal Stenosis	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Large Intestine Perforation	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Small Intestinal Stenosis	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Death	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Acute Hepatic Failure	Hepatobiliary disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Anal Abscess	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Device Related Sepsis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Peritonitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Salmonellosis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Radius Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Lipase Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected44 at risk EG0020 affected73 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Benign Ovarian Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Headache	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Depression Suicidal	Psychiatric disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Ovarian Cyst Ruptured	Reproductive system and breast disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0003 affected72 at risk EG0011 affected44 at risk EG0029 affected73 at risk EG0033 affected48 at risk EG0040 affected31 at risk EG0056 affected50 at risk EG0067 affected49 at risk EG0072 affected49 at risk EG0081 affected47 at risk EG0090 affected10 at risk EG0101 affected12 at risk EG0110 affected21 at risk EG0123 affected27 at risk EG0131 affected24 at risk EG0142 affected28 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0002 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0011 affected44 at risk EG0024 affected73 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0003 affected72 at risk EG0013 affected44 at risk EG0025 affected73 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0004 affected72 at risk EG0010 affected44 at risk EG0026 affected73 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0002 affected72 at risk EG0011 affected44 at risk EG0022 affected73 at risk EG003
Enterovesical Fistula	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected44 at risk EG0020 affected73 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0023 affected73 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0023 affected73 at risk EG003
Fatigue	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0004 affected72 at risk EG0011 affected44 at risk EG0021 affected73 at risk EG003
Pyrexia	General disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0011 affected44 at risk EG0023 affected73 at risk EG003
Cellulitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Influenza	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0011 affected44 at risk EG0024 affected73 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0003 affected72 at risk EG0012 affected44 at risk EG0027 affected73 at risk EG003
Rhinitis	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0024 affected73 at risk EG003
Lymphocyte Count Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0002 affected72 at risk EG0010 affected44 at risk EG0027 affected73 at risk EG003
Neutrophil Count Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0022 affected73 at risk EG003
Platelet Count Increased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Weight Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
White Blood Cell Count Decreased	Investigations	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0024 affected73 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0021 affected73 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected44 at risk EG0021 affected73 at risk EG003
Tumour Inflammation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Headache	Nervous system disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0005 affected72 at risk EG0012 affected44 at risk EG0028 affected73 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0001 affected72 at risk EG0010 affected44 at risk EG0020 affected73 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 23.1	Non-systematic Assessment	EG0000 affected72 at risk EG0011 affected44 at risk EG0022 affected73 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Lone Tree	Colorado		United States

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins