Crohn Disease
Conditions
Brief summary
The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
Interventions
DRUGJNJ-64304500
Participants will receive JNJ-64304500 Subcutaneously.
DRUGPlacebo
Participants will receive placebo Subcutaneously.
DRUGUstekinumab
Participants will receive ustekinumab as per the dosing regimen.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 | Baseline to 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. |
| Part II: Change From Baseline in the CDAI Score at Week 12 | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 | Baseline, 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. |
| Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) | Week 12 | Clinical Remission was defined as a PRO-2 score of \<75 point. |
| Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) | Week 12 | 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. |
| Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | Baseline, 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. |
| 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) | Week 12 | Clinical response was defined as \>=50-point reduction from baseline in PRO-2 or Score or PRO-2 Score \<75. |
| 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) | Week 12 | 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. |
Countries
Belgium, Bulgaria, Canada, France, Germany, Hungary, Japan, Poland, Romania, Russia, South Korea, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
In participant flow, data is reported in 2 periods, \[Main Study and Part II long term extension (LTE) Phase\] depicts the information for the specified time period as: Part I: Through Week 38 (including safety follow-up); Part II: Through Week 24 for participants who entered the LTE phase and through Week 36 for participants who did not enter the LTE.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| 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. | 73 |
| 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. | 48 |
| 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. | 50 |
| 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. | 49 |
| 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. | 49 |
| 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. | 47 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study (Parts I,II): Up to Week 38 | Death | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Main Study (Parts I,II): Up to Week 38 | Lost to Follow-up | 0 | 4 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Main Study (Parts I,II): Up to Week 38 | Other | 1 | 1 | 3 | 6 | 4 | 3 | 2 | 0 | 0 | 0 | 0 | 0 |
| Main Study (Parts I,II): Up to Week 38 | Withdrawal by Subject | 13 | 19 | 5 | 8 | 3 | 6 | 2 | 0 | 0 | 0 | 0 | 0 |
| Part II LTE Phase: From Week 24-88 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Part II LTE Phase: From Week 24-88 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 |
| Part II LTE Phase: From Week 24-88 | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
| Part II LTE Phase: From Week 24-88 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 3 | 9 | 3 |
Baseline characteristics
| Characteristic | Part I: Placebo | Total | Part II: Ustekinumab | Part II: JNJ-64304500 High Dose | Part II: JNJ-64304500 Middle Dose | Part II: JNJ-64304500 Low Dose | Part II: Placebo | Part I: JNJ-64304500 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 13.3 | 38.5 years STANDARD_DEVIATION 13.2 | 42 years STANDARD_DEVIATION 12.62 | 37.2 years STANDARD_DEVIATION 12.87 | 37.1 years STANDARD_DEVIATION 15.04 | 36.4 years STANDARD_DEVIATION 11.14 | 40.6 years STANDARD_DEVIATION 13.69 | 38 years STANDARD_DEVIATION 13.25 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 33 Participants | 7 Participants | 8 Participants | 2 Participants | 6 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 67 Participants | 343 Participants | 40 Participants | 39 Participants | 46 Participants | 43 Participants | 45 Participants | 63 Participants |
| Region of Enrollment BELGIUM | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment BULGARIA | 1 Participants | 7 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment FRANCE | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment GERMANY | 4 Participants | 12 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
| Region of Enrollment HUNGARY | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment ITALY | 3 Participants | 13 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Region of Enrollment JAPAN | 0 Participants | 25 Participants | 6 Participants | 8 Participants | 2 Participants | 6 Participants | 3 Participants | 0 Participants |
| Region of Enrollment POLAND | 14 Participants | 72 Participants | 9 Participants | 11 Participants | 17 Participants | 7 Participants | 5 Participants | 9 Participants |
| Region of Enrollment ROMANIA | 1 Participants | 10 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 20 Participants | 109 Participants | 11 Participants | 15 Participants | 15 Participants | 15 Participants | 19 Participants | 14 Participants |
| Region of Enrollment SOUTH KOREA | 2 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Region of Enrollment UKRAINE | 16 Participants | 80 Participants | 10 Participants | 5 Participants | 9 Participants | 10 Participants | 13 Participants | 17 Participants |
| Region of Enrollment UNITED KINGDOM | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment UNITED STATES | 9 Participants | 42 Participants | 4 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Female | 31 Participants | 174 Participants | 23 Participants | 20 Participants | 27 Participants | 16 Participants | 24 Participants | 33 Participants |
| Sex: Female, Male Male | 41 Participants | 214 Participants | 24 Participants | 29 Participants | 22 Participants | 34 Participants | 24 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 44 | 1 / 73 | 0 / 48 | 0 / 31 | 0 / 50 | 0 / 49 | 1 / 49 | 0 / 47 | 0 / 10 | 0 / 12 | 0 / 21 | 0 / 27 | 0 / 24 | 0 / 28 |
| other Total, other adverse events | 24 / 72 | 10 / 44 | 38 / 73 | 16 / 48 | 6 / 31 | 24 / 50 | 23 / 49 | 26 / 49 | 20 / 47 | 5 / 10 | 5 / 12 | 6 / 21 | 12 / 27 | 10 / 24 | 9 / 28 |
| serious Total, serious adverse events | 1 / 72 | 2 / 44 | 8 / 73 | 3 / 48 | 0 / 31 | 3 / 50 | 0 / 49 | 6 / 49 | 2 / 47 | 1 / 10 | 3 / 12 | 2 / 21 | 5 / 27 | 5 / 24 | 5 / 28 |
Outcome results
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.
Time frame: Baseline to Week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: Placebo | Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 | -60.0 units on a scale | Standard Deviation 77.08 |
| Part I: JNJ-64304500 | Part I: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 8 | -103.6 units on a scale | Standard Deviation 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.
Time frame: Baseline to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: Placebo | Part II: Change From Baseline in the CDAI Score at Week 12 | -59.2 units on a scale | Standard Deviation 89.51 |
| Part I: JNJ-64304500 | Part II: Change From Baseline in the CDAI Score at Week 12 | -93.2 units on a scale | Standard Deviation 117.91 |
| Part II: JNJ-64304500 Middle Dose | Part II: Change From Baseline in the CDAI Score at Week 12 | -72.2 units on a scale | Standard Deviation 92.79 |
| Part II: JNJ-64304500 High Dose | Part II: Change From Baseline in the CDAI Score at Week 12 | -84.3 units on a scale | Standard Deviation 103.28 |
| Part II: Ustekinumab | Part II: Change From Baseline in the CDAI Score at Week 12 | -148.8 units on a scale | Standard Deviation 84.59 |
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: Placebo | Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 | -28.8 units on scale | Standard Deviation 47.72 |
| Part I: JNJ-64304500 | Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 | -46.1 units on scale | Standard Deviation 59.14 |
| Part II: JNJ-64304500 Middle Dose | Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 | -39.8 units on scale | Standard Deviation 52.59 |
| Part II: JNJ-64304500 High Dose | Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 | -42.9 units on scale | Standard Deviation 47.33 |
| Part II: Ustekinumab | Part II: Change From Baseline in Patient-Reported Outcome (PRO)-2 at Week 12 | -70.1 units on scale | Standard Deviation 52.97 |
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: Placebo | Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | -2.2 units on a scale | Standard Deviation 6.58 |
| Part I: JNJ-64304500 | Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | -0.7 units on a scale | Standard Deviation 6.47 |
| Part II: JNJ-64304500 Middle Dose | Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | -1.2 units on a scale | Standard Deviation 4.89 |
| Part II: JNJ-64304500 High Dose | Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | -2.7 units on a scale | Standard Deviation 6.93 |
| Part II: Ustekinumab | Part II: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | -2.6 units on a scale | Standard Deviation 5.32 |
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.
Time frame: Week 12
Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I: Placebo | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) | 14.6 percentage of participants |
| Part I: JNJ-64304500 | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) | 30 percentage of participants |
| Part II: JNJ-64304500 Middle Dose | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) | 18.4 percentage of participants |
| Part II: JNJ-64304500 High Dose | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) | 22.4 percentage of participants |
| Part II: Ustekinumab | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by CDAI (CDAI Less Than [<] 150) | 53.2 percentage of participants |
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.
Time frame: Week 12
Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I: Placebo | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) | 16.7 percentage of participants |
| Part I: JNJ-64304500 | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) | 32.0 percentage of participants |
| Part II: JNJ-64304500 Middle Dose | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) | 30.6 percentage of participants |
| Part II: JNJ-64304500 High Dose | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) | 44.9 percentage of participants |
| Part II: Ustekinumab | Part II: Percentage of Participants in Clinical Remission at Week 12 as Measured by PRO-2 (PRO-2 <75) | 53.2 percentage of participants |
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.
Time frame: Week 12
Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I: Placebo | 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) | 22.9 percentage of participants |
| Part I: JNJ-64304500 | 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) | 42.0 percentage of participants |
| Part II: JNJ-64304500 Middle Dose | 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) | 40.8 percentage of participants |
| Part II: JNJ-64304500 High Dose | 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) | 30.6 percentage of participants |
| Part II: Ustekinumab | 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) | 72.3 percentage of participants |
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.
Time frame: Week 12
Population: FAS included all randomized participants in Part II who received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part I: Placebo | 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) | 31.3 percentage of participants |
| Part I: JNJ-64304500 | 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) | 44.0 percentage of participants |
| Part II: JNJ-64304500 Middle Dose | 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) | 46.9 percentage of participants |
| Part II: JNJ-64304500 High Dose | 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) | 49.0 percentage of participants |
| Part II: Ustekinumab | 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) | 68.1 percentage of participants |