Colitis, Ulcerative
Conditions
Keywords
Guselkumab, Colitis, Ulcerative
Brief summary
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Interventions
Guselkumab (Dose 1) will be administered as SC injection.
Guselkumab (Dose 2) will be administered as SC injection.
Guselkumab (Dose 3) will be administered as SC injection.
OTHERPlacebo
Placebo will be administered as SC injection.
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
* Signed informed consent form * 18 years of age or older * Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening * Moderately to severely active UC as per the modified Mayo score * Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion criteria
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease * Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention * Receiving prohibited medications and treatments * UC limited to the rectum only * Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Clinical Remission at Week 12 | Week 12 | Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Symptomatic Remission at Week 12 | Week 12 | Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. |
| Percentage of Participants With Endoscopic Improvement at Week 12 | Week 12 | Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. |
| Percentage of Participants in Clinical Response at Week 12 | Week 12 | Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. |
| Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12 | Week 12 | Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. |
| Percentage of Participants in Clinical Remission at Week 24 | Week 24 | Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. |
| Percentage of Participants in Symptomatic Remission at Week 24 | Week 24 | Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. |
| Percentage of Participants With Endoscopic Improvement at Week 24 | Week 24 | Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. |
| Percentage of Participants in Clinical Response at Week 24 | Week 24 | Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by \>= 30% and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, India, Israel, Japan, Jordan, Malaysia, Mexico, New Zealand, Poland, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Participant flow
Recruitment details
Results are currently reported up to the primary completion date (02-Apr-2024). Results of remaining duration will be posted upon study completion.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24. | 139 |
| Guselkumab 400 mg q4w - Guselkumab 100 mg q8w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. | 139 |
| Guselkumab 400 mg q4w - Guselkumab 200 mg q4w Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. | 140 |
| Total | 418 |
Baseline characteristics
| Characteristic | Placebo | Total | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Guselkumab 400 mg q4w - Guselkumab 100 mg q8w |
|---|---|---|---|---|
| AgeCategorical 65 years and over | 8 Participants | 33 Participants | 9 Participants | 16 Participants |
| AgeCategorical Adults (18-64 years) | 131 Participants | 385 Participants | 131 Participants | 123 Participants |
| Age, Continuous | 39.5 years STANDARD_DEVIATION 13.58 | 41.7 years STANDARD_DEVIATION 14.22 | 43.6 years STANDARD_DEVIATION 14.27 | 42.1 years STANDARD_DEVIATION 14.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 79 Participants | 26 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 112 Participants | 326 Participants | 112 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 13 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 121 Participants | 40 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 13 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 94 Participants | 270 Participants | 91 Participants | 85 Participants |
| Region of Enrollment ARGENTINA | 4 Participants | 11 Participants | 3 Participants | 4 Participants |
| Region of Enrollment AUSTRALIA | 2 Participants | 7 Participants | 3 Participants | 2 Participants |
| Region of Enrollment BELGIUM | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment BRAZIL | 17 Participants | 54 Participants | 19 Participants | 18 Participants |
| Region of Enrollment BULGARIA | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Region of Enrollment CANADA | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment CHINA | 19 Participants | 47 Participants | 16 Participants | 12 Participants |
| Region of Enrollment CZECH REPUBLIC | 4 Participants | 12 Participants | 3 Participants | 5 Participants |
| Region of Enrollment FRANCE | 3 Participants | 12 Participants | 3 Participants | 6 Participants |
| Region of Enrollment GERMANY | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Region of Enrollment HUNGARY | 3 Participants | 8 Participants | 4 Participants | 1 Participants |
| Region of Enrollment INDIA | 3 Participants | 13 Participants | 8 Participants | 2 Participants |
| Region of Enrollment ISRAEL | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Region of Enrollment JAPAN | 7 Participants | 32 Participants | 10 Participants | 15 Participants |
| Region of Enrollment JORDAN | 9 Participants | 21 Participants | 6 Participants | 6 Participants |
| Region of Enrollment MALAYSIA | 2 Participants | 7 Participants | 2 Participants | 3 Participants |
| Region of Enrollment MEXICO | 1 Participants | 12 Participants | 6 Participants | 5 Participants |
| Region of Enrollment NEW ZEALAND | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Region of Enrollment POLAND | 31 Participants | 93 Participants | 34 Participants | 28 Participants |
| Region of Enrollment SLOVAKIA | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Region of Enrollment SOUTH KOREA | 7 Participants | 15 Participants | 2 Participants | 6 Participants |
| Region of Enrollment SPAIN | 5 Participants | 6 Participants | 0 Participants | 1 Participants |
| Region of Enrollment TAIWAN | 0 Participants | 4 Participants | 1 Participants | 3 Participants |
| Region of Enrollment TURKEY | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Region of Enrollment UNITED STATES | 10 Participants | 33 Participants | 13 Participants | 10 Participants |
| Sex: Female, Male Female | 49 Participants | 162 Participants | 53 Participants | 60 Participants |
| Sex: Female, Male Male | 90 Participants | 256 Participants | 87 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 139 | 0 / 52 | 0 / 139 | 0 / 140 |
| other Total, other adverse events | 48 / 139 | 5 / 52 | 47 / 139 | 39 / 140 |
| serious Total, serious adverse events | 17 / 139 | 1 / 52 | 5 / 139 | 6 / 140 |
Outcome results
Primary
Percentage of Participants in Clinical Remission at Week 12
Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
Time frame: Week 12
Population: Full analysis set (FAS) included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of Guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Clinical Remission at Week 12 | 6.5 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants in Clinical Remission at Week 12 | 27.6 Percentage of participants |
p-value: <0.00195% CI: [14.5, 27.6]Mantel Haenszel
Secondary
Percentage of Participants in Clinical Remission at Week 24
Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Clinical Remission at Week 24 | 9.4 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants in Clinical Remission at Week 24 | 35.3 Percentage of participants |
| Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Percentage of Participants in Clinical Remission at Week 24 | 36.4 Percentage of participants |
p-value: <0.00195% CI: [16.7, 35.1]Mantel Haenszel
p-value: <0.00195% CI: [17.9, 36.2]Mantel Haenszel
Secondary
Percentage of Participants in Clinical Response at Week 12
Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.
Time frame: Week 12
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Clinical Response at Week 12 | 34.5 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants in Clinical Response at Week 12 | 65.6 Percentage of participants |
p-value: <0.00195% CI: [21.6, 40.5]Mantel Haenszel
Secondary
Percentage of Participants in Clinical Response at Week 24
Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by \>= 30% and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Clinical Response at Week 24 | 30.9 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants in Clinical Response at Week 24 | 63.3 Percentage of participants |
| Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Percentage of Participants in Clinical Response at Week 24 | 61.4 Percentage of participants |
p-value: <0.00195% CI: [21.3, 43.4]Mantel Haenszel
p-value: <0.00195% CI: [20, 41]Mantel Haenszel
Secondary
Percentage of Participants in Symptomatic Remission at Week 12
Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.
Time frame: Week 12
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of Guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Symptomatic Remission at Week 12 | 20.9 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants in Symptomatic Remission at Week 12 | 51.3 Percentage of participants |
p-value: <0.00195% CI: [21.6, 39.2]Mantel Haenszel
Secondary
Percentage of Participants in Symptomatic Remission at Week 24
Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Symptomatic Remission at Week 24 | 25.2 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants in Symptomatic Remission at Week 24 | 54.7 Percentage of participants |
| Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Percentage of Participants in Symptomatic Remission at Week 24 | 50.0 Percentage of participants |
p-value: <0.00195% CI: [18.5, 40.5]Mantel Haenszel
p-value: <0.00195% CI: [14.3, 35.3]Mantel Haenszel
Secondary
Percentage of Participants With Endoscopic Improvement at Week 12
Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
Time frame: Week 12
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Endoscopic Improvement at Week 12 | 12.9 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants With Endoscopic Improvement at Week 12 | 37.3 Percentage of participants |
p-value: <0.00195% CI: [16.6, 31.9]Mantel Haenszel
Secondary
Percentage of Participants With Endoscopic Improvement at Week 24
Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
Time frame: Week 24
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Endoscopic Improvement at Week 24 | 12.2 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants With Endoscopic Improvement at Week 24 | 40.3 Percentage of participants |
| Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Percentage of Participants With Endoscopic Improvement at Week 24 | 45.0 Percentage of participants |
p-value: <0.00195% CI: [18.5, 37.6]Mantel Haenszel
p-value: <0.00195% CI: [23.1, 42.3]Mantel Haenszel
Secondary
Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12
Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
Time frame: Week 12
Population: FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12 | 10.8 Percentage of participants |
| Combined Guselkumab 400 mg | Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12 | 30.5 Percentage of participants |
p-value: <0.00195% CI: [12.4, 26.9]Mantel Haenszel