Crohns Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.
Interventions
DRUGGuselkumab
Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence * Have screening laboratory test results within the protocol specified parameters * A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline * Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion criteria
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation * Unstable doses of concomitant Crohn's disease therapy * Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol * Prior exposure to p40 inhibitors or p19 inhibitors * Any medical contraindications preventing study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From baseline (Week 0) up to Week 48 | Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs (TEAEs) were AEs with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. All TEAEs including serious and non-serious AEs were reported. |
| Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From baseline (Week 0) up to Week 48 | Number of participants with TESAEs were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) | From baseline (Week 0) up to Week 48 | Number of participants with TEAESI was reported. Active tuberculosis (TB) or malignancies were considered as TEAESIs. TEAESIs were AESIs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. |
| Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | From baseline (Week 0) up to Week 48 | Number of participants with treatment-emergent abnormalities in hematology laboratory parameters were reported. Laboratory tests included in hematology were hemoglobin, lymphocytes, neutrophils, platelet count, Total WBC (white blood cell) Count. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. |
| Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | From baseline (Week 0) up to Week 48 | Number of participants with treatment-emergent abnormalities in chemistry laboratory parameters were reported. Laboratory parameters included in clinical chemistry were albumin, corrected calcium, creatinine, glucose, potassium, sodium. NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. |
| Number of Participants With TEAEs of Infections | From baseline (Week 0) up to Week 48 | Number of participants with TEAEs of infections were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. |
| Number of Participants With TEAEs of Injection-site Reactions | From baseline (Week 0) up to Week 48 | Number of participants with TEAEs of injection-site reactions were reported. A significant injection-site reaction was defined as an adverse reaction that was manifested through 1 or more of the following symptoms: significant bruising, erythema, hemorrhage, irritation, pain, pruritus at the site of injection. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline. |
| Number of Participants With TEAEs Temporally Associated With Infusion | From baseline (Week 0) up to Week 48 | Number of participants with TEAEs temporally associated with infusion were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that had worsened since baseline. |
| Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent | From baseline (Week 0) up to Week 48 | TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. The Columbia-suicide severity rating scale (C-SSRS) defined was 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as non-suicidal self-injurious behavior and completed suicide. The C-SSRS was an investigator-administered questionnaire: 1) No suicidal ideation or behaviors (including self-injurious behavior without suicidal intent): No further action was needed; 2) Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior; participant risk is assessed by the investigator. 3) Suicidal ideation levels 4 or 5 or any suicidal behavior: participant risk assessed and referral to a mental health professional. If no events qualify for scores of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicated greater severity. |
| Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs | From baseline (Week 0) up to Week 48 | Number of participants with clinically significant treatment-emergent abnormalities in vital signs were reported. Vital signs included weight, pulse rate, temperature, respiratory rate, systolic blood pressure, and diastolic blood pressure. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. |
| Number of Participants With Concomitant Medications for Crohn's Disease | From screening (Week -8) up to Week 48 | Number of participants with concomitant medications for Crohn's disease were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response Through Week 48 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Number of participants with clinical response through Week 48 were reported. Clinical response was defined as a greater than or equal to (\>=) 100-point reduction from baseline in CDAI score or CDAI score less than \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity. |
| Number of Participants With Clinical Remission Through Week 48 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Number of participants with clinical remission through Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity. |
| Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Number of participants with PRO-2 remission through Week 48 were reported. PRO-2 remission was defined as abdominal pain (AP) mean daily score at or below 1 and stool frequency (SF) mean daily score at or below 3, and no worsening of AP or SF from baseline. Mean daily AP score was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores score at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease. |
| Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48 | Baseline (Week 0) and Week 48 | Change from baseline in SES-CD score at Week 48 were reported. The SES-CD score was used to evaluate endoscopic improvement. The SES-CD was based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for the narrowing component which only attain a maximum total score of 11 because, the presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease. |
| Serum Concentation of Guselkumab | Predose at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 1 hour post dose at Weeks 0, 4, 8 | Serum concentration of guselkumab were reported. |
| Number of Participants With Anti-Guselkumab Antibodies Through Week 48 | From Week 0 through Week 48 | Number of participants with anti-guselkumab antibodies through Week 48 were reported. |
| Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48 | From Week 0 through Week 48 | Number of participants with neutralizing-guselkumab antibodies through Week 48 were reported. |
| Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48 | Change from baseline in inflammatory PD marker of CRP concentration were reported. |
| Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels | Baseline (Week 0), Weeks 4, 8, 12, 24, and 48 | Change from baseline in inflammatory PD marker of FC levels were reported. |
| Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | At Week 48 | Change from baseline in CDAI score at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity. |
| Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | At Week 48 | Number of participants in clinical response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical response was defined as a \>=100-point reduction from baseline in CDAI score or CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity. |
| Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | At Week 48 | Number of participants in clinical remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity. |
| Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | At Week 48 | Number of participants in endoscopic response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic response was defined as \>=50 % improvement from baseline in SES-CD score or SES-CD score less than or equal to (\<=) 2. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores across all segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease. |
| Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | At Week 48 | Number of participants in endoscopic remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic remission: an SES-CD score \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual subcomponent. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in total score of 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores (all segments) \& it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease. |
| Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Change from baseline in the average daily P.Eq oral corticosteroid dose (excluding Budesonide) through Week 48 among participants receiving oral corticosteroids other than Budesonide at baseline were reported. |
| Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline | At Week 48 | Number of participants not receiving concomitant corticosteroids at Week 48 among participants receiving concomitant corticosteroids at baseline were reported. |
| Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline | Up to Week 48 | Number of participants not receiving concomitant corticosteroids for at least 30 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported. |
| Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline | Up to Week 48 | Number of participants not receiving concomitant corticosteroids for at least 90 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported. |
Countries
Japan
Contacts
STUDY_DIRECTORJanssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Participant flow
Pre-assignment details
Upon completion of the open-label treatment phase, participants were permitted to enter the long-term extension (LTE) phase. The LTE phase is ongoing and results will be published after the completion of the study.
Participants by arm
| Arm | Count |
|---|---|
| Guselkumab 200 Milligrams (mg) Participants received guselkumab 200 mg by intravenous (IV) infusion induction doses at Weeks 0, 4, and 8, followed by guselkumab 200 mg subcutaneous (SC) injection maintenance doses at every 4 weeks (q4w) after Week 8 up to Week 44. The participants who were eligible and willing to continue guselkumab entered the Long-term extension (LTE) phase at Week 48 and continued to receive guselkumab 200 mg SC injection q4w from Week 48 in the LTE phase. A post treatment safety follow-up visit was conducted 12 weeks after last dose of study drug. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Guselkumab 200 Milligrams (mg) |
|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 14.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 38 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 38 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 26 / 38 |
| serious Total, serious adverse events | 3 / 38 |
Outcome results
Primary
Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs
Number of participants with clinically significant treatment-emergent abnormalities in vital signs were reported. Vital signs included weight, pulse rate, temperature, respiratory rate, systolic blood pressure, and diastolic blood pressure. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Vital Signs | 0 Participants |
Primary
Number of Participants With Concomitant Medications for Crohn's Disease
Number of participants with concomitant medications for Crohn's disease were reported.
Time frame: From screening (Week -8) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Concomitant Medications for Crohn's Disease | Oral amino salicylates | 28 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Concomitant Medications for Crohn's Disease | 6- mercaptopurine/azathioprine | 16 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Concomitant Medications for Crohn's Disease | oral corticosteroids | 12 Participants |
Primary
Number of Participants With TEAEs of Infections
Number of participants with TEAEs of infections were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With TEAEs of Infections | 11 Participants |
Primary
Number of Participants With TEAEs of Injection-site Reactions
Number of participants with TEAEs of injection-site reactions were reported. A significant injection-site reaction was defined as an adverse reaction that was manifested through 1 or more of the following symptoms: significant bruising, erythema, hemorrhage, irritation, pain, pruritus at the site of injection. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With TEAEs of Injection-site Reactions | 3 Participants |
Primary
Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent
TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. The Columbia-suicide severity rating scale (C-SSRS) defined was 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as non-suicidal self-injurious behavior and completed suicide. The C-SSRS was an investigator-administered questionnaire: 1) No suicidal ideation or behaviors (including self-injurious behavior without suicidal intent): No further action was needed; 2) Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior; participant risk is assessed by the investigator. 3) Suicidal ideation levels 4 or 5 or any suicidal behavior: participant risk assessed and referral to a mental health professional. If no events qualify for scores of 1 to 10, score of 0 was assigned (0= no event that can be assessed on the basis of C-SSRS). Higher scores indicated greater severity.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent | 0 Participants |
Primary
Number of Participants With TEAEs Temporally Associated With Infusion
Number of participants with TEAEs temporally associated with infusion were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that had worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With TEAEs Temporally Associated With Infusion | 0 Participants |
Primary
Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters
Number of participants with treatment-emergent abnormalities in chemistry laboratory parameters were reported. Laboratory parameters included in clinical chemistry were albumin, corrected calcium, creatinine, glucose, potassium, sodium. NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, n(number analyzed) signifies number of participants analyzed at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (decreased): Grade 2 | 5 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Albumin (decreased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Albumin (decreased): Grade 2 | 1 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Albumin (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Albumin (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (increased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (increased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (decreased): Grade 1 | 3 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (decreased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Corrected Calcium (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Creatinine (increased): Grade 1 | 2 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Creatinine (increased): Grade 2 | 1 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Creatinine (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Creatinine (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Glucose (decreased): Grade 1 | 1 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Glucose (decreased): Grade 2 | 1 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Glucose (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Glucose (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (increased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (increased): Grade 2 | 1 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (decreased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Potassium (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (increased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (increased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (decreased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (decreased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Chemistry Laboratory Parameters | Sodium (decreased): Grade 4 | 0 Participants |
Primary
Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters
Number of participants with treatment-emergent abnormalities in hematology laboratory parameters were reported. Laboratory tests included in hematology were hemoglobin, lymphocytes, neutrophils, platelet count, Total WBC (white blood cell) Count. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, n(number analyzed) signifies number of participants analyzed at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Neutrophils (decreased): Grade 2 | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Neutrophils (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Neutrophils (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Platelets (decreased): Grade 1 | 1 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Platelets (decreased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Platelets (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (increased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (increased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (decreased): Grade 1 | 18 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (decreased): Grade 2 | 2 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (decreased): Grade 3 | 3 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Hemoglobin (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (increased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (increased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (decreased): Grade 1 | 5 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (decreased): Grade 2 | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (decreased): Grade 3 | 4 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Lymphocytes (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Neutrophils (decreased): Grade 1 | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Platelets (decreased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (increased): Grade 1 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (increased): Grade 2 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (increased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (increased): Grade 4 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (decreased): Grade 1 | 9 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (decreased): Grade 2 | 9 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (decreased): Grade 3 | 0 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Abnormalities in Hematology Laboratory Parameters | Total WBC Count (decreased): Grade 4 | 0 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
Number of participants with TEAESI was reported. Active tuberculosis (TB) or malignancies were considered as TEAESIs. TEAESIs were AESIs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs (TEAEs) were AEs with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. All TEAEs including serious and non-serious AEs were reported.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 33 Participants |
Primary
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Number of participants with TESAEs were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From baseline (Week 0) up to Week 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 3 Participants |
Secondary
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
Change from baseline in CDAI score at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Time frame: At Week 48
Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | <= 1st Quartile Concentration | -171.7 score on a scale | Standard Deviation 152.12 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 1st Quartile and <= 2nd Quartile Concentration | -137.6 score on a scale | Standard Deviation 74.78 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | >2nd Quartile and <= 3rd Quartile Concentration | -157.5 score on a scale | Standard Deviation 124.85 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 3rd Quartile Concentration | -146.0 score on a scale | Standard Deviation 111.21 |
Secondary
Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels
Change from baseline in inflammatory PD marker of FC levels were reported.
Time frame: Baseline (Week 0), Weeks 4, 8, 12, 24, and 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, 'n' signifies number of participants evaluable at each specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels | Week 4 | -270.0 milligrams per kilogram (mg/kg) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels | Week 8 | -252.5 milligrams per kilogram (mg/kg) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels | Week 12 | -380.0 milligrams per kilogram (mg/kg) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels | Week 24 | -310.0 milligrams per kilogram (mg/kg) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory PD Marker: Fecal Calprotectin (FC) Levels | Week 48 | -280.0 milligrams per kilogram (mg/kg) |
Secondary
Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration
Change from baseline in inflammatory PD marker of CRP concentration were reported.
Time frame: Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48
Population: Safety analysis set included all enrolled participants who received at least 1 dose of guselkumab. Here, 'n' signifies number of participants evaluable at each specified timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 32 | -1.25 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 40 | -1.05 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 4 | -1.65 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 8 | -2.20 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 12 | -2.40 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 16 | -0.90 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 20 | -0.70 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 24 | -1.60 milligrams per liter (mg/L) |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Inflammatory Pharmacodynamic (PD) Marker: C-reactive Protein (CRP) Concentration | Week 48 | -1.65 milligrams per liter (mg/L) |
Secondary
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48
Change from baseline in SES-CD score at Week 48 were reported. The SES-CD score was used to evaluate endoscopic improvement. The SES-CD was based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for the narrowing component which only attain a maximum total score of 11 because, the presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Time frame: Baseline (Week 0) and Week 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 48 | -6.4 score on a scale | Standard Deviation 7 |
Secondary
Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline
Change from baseline in the average daily P.Eq oral corticosteroid dose (excluding Budesonide) through Week 48 among participants receiving oral corticosteroids other than Budesonide at baseline were reported.
Time frame: Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 32 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 4 | 0.00 milligram per day (mg/day) | Standard Deviation 0 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 8 | 0.00 milligram per day (mg/day) | Standard Deviation 0 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 12 | 0.00 milligram per day (mg/day) | Standard Deviation 0 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 16 | -9.06 milligram per day (mg/day) | Standard Deviation 6.722 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 20 | -13.13 milligram per day (mg/day) | Standard Deviation 8.509 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 24 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 28 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 36 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 40 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 44 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
| Guselkumab 200 Milligrams (mg) | Change From Baseline in the Average Daily Prednisone-equivalent (P.Eq) Oral Corticosteroid Dose (Excluding Budesonide) Through Week 48 Among Participants Receiving Oral Corticosteroids Other Than Budesonide at Baseline | Week 48 | -13.75 milligram per day (mg/day) | Standard Deviation 7.5 |
Secondary
Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
Number of participants in clinical remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Time frame: At Week 48
Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | <= 1st Quartile Concentration | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 1st Quartile and <= 2nd Quartile Concentration | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | >2nd Quartile and <= 3rd Quartile Concentration | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 3rd Quartile Concentration | 8 Participants |
Secondary
Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
Number of participants in clinical response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical response was defined as a \>=100-point reduction from baseline in CDAI score or CDAI score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Time frame: At Week 48
Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | <= 1st Quartile Concentration | 8 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 1st Quartile and <= 2nd Quartile Concentration | 8 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | >2nd Quartile and <= 3rd Quartile Concentration | 7 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Clinical Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 3rd Quartile Concentration | 8 Participants |
Secondary
Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
Number of participants in endoscopic remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic remission: an SES-CD score \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual subcomponent. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in total score of 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores (all segments) & it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Time frame: At Week 48
Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | <= 1st Quartile Concentration | 2 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 1st Quartile and <= 2nd Quartile Concentration | 3 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | >2nd Quartile and <= 3rd Quartile Concentration | 4 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Remission at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 3rd Quartile Concentration | 4 Participants |
Secondary
Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48
Number of participants in endoscopic response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic response was defined as \>=50 % improvement from baseline in SES-CD score or SES-CD score less than or equal to (\<=) 2. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores across all segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
Time frame: At Week 48
Population: The PK/PD analysis set included all enrolled participants who had evaluable data of both PK and PD at the same visit which included Week 12, Week 24 or Week 48 visit. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure and 'n' signifies number of participants evaluable at each specified concentration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | <= 1st Quartile Concentration | 4 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 1st Quartile and <= 2nd Quartile Concentration | 4 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | >2nd Quartile and <= 3rd Quartile Concentration | 5 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants in Endoscopic Response at Week 48 by Serum Guselkumab Concentration Quartiles at Week 48 | > 3rd Quartile Concentration | 5 Participants |
Secondary
Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
Number of participants not receiving concomitant corticosteroids at Week 48 among participants receiving concomitant corticosteroids at baseline were reported.
Time frame: At Week 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants Not Receiving Concomitant Corticosteroids at Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline | 9 Participants |
Secondary
Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
Number of participants not receiving concomitant corticosteroids for at least 30 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.
Time frame: Up to Week 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants Not Receiving Concomitant Corticosteroids for at Least 30 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline | 9 Participants |
Secondary
Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline
Number of participants not receiving concomitant corticosteroids for at least 90 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.
Time frame: Up to Week 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants Not Receiving Concomitant Corticosteroids for at Least 90 Days Prior to Week 48 Among Participants Receiving Concomitant Corticosteroids at Baseline | 9 Participants |
Secondary
Number of Participants With Anti-Guselkumab Antibodies Through Week 48
Number of participants with anti-guselkumab antibodies through Week 48 were reported.
Time frame: From Week 0 through Week 48
Population: Immunogenicity analysis set included all enrolled participants who received at least 1 dose of guselkumab and had at least 1 observed post dose immune response data. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Anti-Guselkumab Antibodies Through Week 48 | 1 Participants |
Secondary
Number of Participants With Clinical Remission Through Week 48
Number of participants with clinical remission through Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 4 | 17 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 8 | 19 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 12 | 23 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 16 | 23 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 20 | 22 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 24 | 25 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 28 | 25 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 32 | 25 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 36 | 26 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 40 | 23 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 44 | 25 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Remission Through Week 48 | Week 48 | 29 Participants |
Secondary
Number of Participants With Clinical Response Through Week 48
Number of participants with clinical response through Week 48 were reported. Clinical response was defined as a greater than or equal to (\>=) 100-point reduction from baseline in CDAI score or CDAI score less than \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 8 | 25 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 36 | 29 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 44 | 29 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 4 | 20 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 12 | 30 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 16 | 28 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 20 | 28 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 24 | 30 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 28 | 29 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 32 | 29 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 40 | 28 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Clinical Response Through Week 48 | Week 48 | 31 Participants |
Secondary
Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48
Number of participants with neutralizing-guselkumab antibodies through Week 48 were reported.
Time frame: From Week 0 through Week 48
Population: Immunogenicity analysis set included all enrolled participants who received at least 1 dose of guselkumab and had at least 1 observed post dose immune response data. Here, 'N' (number of participants analyzed) signifies participants who were analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Neutralizing-Guselkumab Antibodies Through Week 48 | 0 Participants |
Secondary
Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48
Number of participants with PRO-2 remission through Week 48 were reported. PRO-2 remission was defined as abdominal pain (AP) mean daily score at or below 1 and stool frequency (SF) mean daily score at or below 3, and no worsening of AP or SF from baseline. Mean daily AP score was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores score at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: The FAS included all enrolled participants who received at least 1 dose of guselkumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 4 | 6 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 8 | 12 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 12 | 16 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 16 | 16 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 20 | 19 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 24 | 18 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 28 | 21 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 32 | 19 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 36 | 20 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 40 | 21 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 44 | 23 Participants |
| Guselkumab 200 Milligrams (mg) | Number of Participants With Patient-reported Outcome(s) (PRO)-2 Remission Through Week 48 | Week 48 | 22 Participants |
Secondary
Serum Concentation of Guselkumab
Serum concentration of guselkumab were reported.
Time frame: Predose at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 1 hour post dose at Weeks 0, 4, 8
Population: Pharmacokinetics (PK) analysis set included all enrolled participants who received at least 1 complete dose of guselkumab and have at least 1 valid blood sample drawn for PK analysis after their first dose of guselkumab. Here, 'n' signifies the number of participants evaluable at each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 0: pre-dose | NA micrograms/milliliter (mcg/mL) | — |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 0: 1 hour post dose | 60.567 micrograms/milliliter (mcg/mL) | Standard Deviation 7.8417 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 4: pre-dose | 6.656 micrograms/milliliter (mcg/mL) | Standard Deviation 2.5431 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 4: 1 hour post dose | 63.556 micrograms/milliliter (mcg/mL) | Standard Deviation 10.7183 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 8: pre-dose | 8.679 micrograms/milliliter (mcg/mL) | Standard Deviation 3.1697 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 8: 1 hour post dose | 65.484 micrograms/milliliter (mcg/mL) | Standard Deviation 7.8536 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 12: pre-dose | 9.691 micrograms/milliliter (mcg/mL) | Standard Deviation 4.4559 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 16: pre-dose | 9.143 micrograms/milliliter (mcg/mL) | Standard Deviation 4.3351 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 20: pre-dose | 8.761 micrograms/milliliter (mcg/mL) | Standard Deviation 4.3497 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 24: pre-dose | 8.966 micrograms/milliliter (mcg/mL) | Standard Deviation 4.6369 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 32: pre-dose | 8.381 micrograms/milliliter (mcg/mL) | Standard Deviation 3.727 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 40: pre-dose | 9.417 micrograms/milliliter (mcg/mL) | Standard Deviation 5.3775 |
| Guselkumab 200 Milligrams (mg) | Serum Concentation of Guselkumab | Week 48: pre-dose | 8.885 micrograms/milliliter (mcg/mL) | Standard Deviation 4.4065 |