Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease (NCT NCT03782376)

NCT ID: NCT03782376

Last Updated: 2025-04-29

Results Overview

Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 215 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2025-04-29

Participant Flow

Participant milestones

Measure	Group 1: Ustekinumab (IV Re-induction) Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Overall Study STARTED	108	107
Overall Study COMPLETED	82	77
Overall Study NOT COMPLETED	26	30

Reasons for withdrawal

Measure	Group 1: Ustekinumab (IV Re-induction) Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	7	11
Overall Study Death	1	0
Overall Study Other	16	17

Baseline Characteristics

A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Baseline characteristics by cohort

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Total n=215 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 13.63 • n=5 Participants	40 years STANDARD_DEVIATION 13.07 • n=7 Participants	40.9 years STANDARD_DEVIATION 13.36 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	103 Participants n=5 Participants	103 Participants n=7 Participants	206 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	90 Participants n=5 Participants	89 Participants n=7 Participants	179 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Czech Republic	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment France	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment Germany	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Region of Enrollment Italy	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Republic of Korea	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Russia	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Spain	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Sweden	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States of America	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Full analysis set included all randomized participants.

Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Clinical Response at Week 16	49.1 Percentage of participants	37.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set included all randomized participants.

Percentage of participants with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Clinical Remission at Week 16	33.3 Percentage of participants	27.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Full analysis set included all randomized participants.

Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Clinical Response at Week 8	51.9 Percentage of participants	44.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Full analysis set included all randomized participants.

Percentage of participants with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Clinical Remission at Week 8	35.2 Percentage of participants	29.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline.

Percentage of participants with normalization at Week 16, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=93 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=94 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16	33.3 Percentage of participants	14.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set included all randomized participants.

Percentage of participants with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Clinical Remission at Week 24	37.0 Percentage of participants	27.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set included all randomized participants.

Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Clinical Response at Week 24	47.2 Percentage of participants	39.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline.

Percentage of participants with normalization at Week 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=93 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=94 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24	26.9 Percentage of participants	21.3 Percentage of participants

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 36

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.

An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	70.4 Percentage of participants	72.9 Percentage of participants

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 36

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.

A serious adverse event (SAE) was an adverse event 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; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	8.3 Percentage of participants	12.1 Percentage of participants

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 36

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.

Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Treatment-emergent Infections	33.3 Percentage of participants	29.9 Percentage of participants

SECONDARY outcome

Timeframe: From baseline (Week 0) up to Week 36

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.

Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Percentage of Participants With Treatment-emergent Serious Infections	1.9 Percentage of participants	1.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.

Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=103 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=98 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 8: Hematology (Hemoglobin)	2.893 Grams per liter (g/L) Standard Deviation 9.5568	-0.185 Grams per liter (g/L) Standard Deviation 7.8669
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 16: Hematology (Hemoglobin)	3.245 Grams per liter (g/L) Standard Deviation 10.4621	0.835 Grams per liter (g/L) Standard Deviation 10.4652
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 24: Hematology (Hemoglobin)	3.203 Grams per liter (g/L) Standard Deviation 11.2408	-0.400 Grams per liter (g/L) Standard Deviation 11.2610
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 8: Chemistry (Albumin)	0.765 Grams per liter (g/L) Standard Deviation 2.9456	0.286 Grams per liter (g/L) Standard Deviation 2.6671
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 16: Chemistry (Albumin)	0.567 Grams per liter (g/L) Standard Deviation 3.0649	0.554 Grams per liter (g/L) Standard Deviation 3.3753
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 24: Chemistry (Albumin)	0.741 Grams per liter (g/L) Standard Deviation 2.9613	0.221 Grams per liter (g/L) Standard Deviation 3.1690
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 8: Chemistry (Total protein)	0.588 Grams per liter (g/L) Standard Deviation 4.6806	0.265 Grams per liter (g/L) Standard Deviation 4.3803
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 16: Chemistry (Total protein)	0.340 Grams per liter (g/L) Standard Deviation 5.2418	0.783 Grams per liter (g/L) Standard Deviation 4.7690
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) Week 24: Chemistry (Total protein)	0.605 Grams per liter (g/L) Standard Deviation 4.4150	0.333 Grams per liter (g/L) Standard Deviation 5.4954

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.

Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=101 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=88 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) Week 8	0.009 Percentage of red blood cells Standard Deviation 0.0313	-0.001 Percentage of red blood cells Standard Deviation 0.277
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) Week 16	0.010 Percentage of red blood cells Standard Deviation 0.0306	0.001 Percentage of red blood cells Standard Deviation 0.0356
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) Week 24	0.009 Percentage of red blood cells Standard Deviation 0.0358	0.001 Percentage of red blood cells Standard Deviation 0.0349

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specific parameters.

Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=103 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=92 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 8: Total WBC	-0.386 10^9 cells/L Standard Deviation 1.8358	-0.272 10^9 cells/L Standard Deviation 1.7301
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 16: Total WBC	-0.329 10^9 cells/L Standard Deviation 2.2700	-0.124 10^9 cells/L Standard Deviation 2.1404
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 24: Total WBC	-0.149 10^9 cells/L Standard Deviation 2.2347	0.104 10^9 cells/L Standard Deviation 1.6612
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 8:Neutrophils	-0.235 10^9 cells/L Standard Deviation 1.7610	-0.241 10^9 cells/L Standard Deviation 1.6154
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 16: Neutrophils	-0.195 10^9 cells/L Standard Deviation 2.0172	-0.053 10^9 cells/L Standard Deviation 2.1811
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 24: Neutrophils	-0.038 10^9 cells/L Standard Deviation 2.2944	0.133 10^9 cells/L Standard Deviation 1.4312
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 8: Absolute Lymphocytes	-0.101 10^9 cells/L Standard Deviation 0.4962	-0.020 10^9 cells/L Standard Deviation 0.3415
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 16: Absolute Lymphocytes	-0.088 10^9 cells/L Standard Deviation 0.5690	-0.052 10^9 cells/L Standard Deviation 0.3997
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 24: Absolute Lymphocytes	-0.088 10^9 cells/L Standard Deviation 0.6599	-0.021 10^9 cells/L Standard Deviation 0.3960
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 8: Eosinophils	-0.009 10^9 cells/L Standard Deviation 0.0876	-0.004 10^9 cells/L Standard Deviation 0.1153
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 16: Eosinophils	-0.014 10^9 cells/L Standard Deviation 0.1176	-0.013 10^9 cells/L Standard Deviation 0.1330
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 24: Eosinophils	-0.001 10^9 cells/L Standard Deviation 0.0912	-0.008 10^9 cells/L Standard Deviation 0.1136
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 8: Platelets	-13.65 10^9 cells/L Standard Deviation 56.553	-0.67 10^9 cells/L Standard Deviation 51.591
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 16: Platelets	-13.28 10^9 cells/L Standard Deviation 60.105	4.53 10^9 cells/L Standard Deviation 60.785
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) Week 24: Platelets	-10.89 10^9 cells/L Standard Deviation 62.671	-0.53 10^9 cells/L Standard Deviation 56.624

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.

Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=102 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=98 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 24: AST	0.741 Units per Liter (U/L) Standard Deviation 5.6718	1.519 Units per Liter (U/L) Standard Deviation 7.3047
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 8: Alkaline Phosphatase	-1.343 Units per Liter (U/L) Standard Deviation 10.7404	-0.582 Units per Liter (U/L) Standard Deviation 10.3565
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 16: Alkaline Phosphatase	-0.072 Units per Liter (U/L) Standard Deviation 12.9488	0.923 Units per Liter (U/L) Standard Deviation 11.5154
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 24: Alkaline Phosphatase	-0.296 Units per Liter (U/L) Standard Deviation 14.2649	0.078 Units per Liter (U/L) Standard Deviation 16.1594
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 8: ALT	-0.347 Units per Liter (U/L) Standard Deviation 9.3642	-0.412 Units per Liter (U/L) Standard Deviation 7.9001
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 16: ALT	-0.811 Units per Liter (U/L) Standard Deviation 8.3898	-0.101 Units per Liter (U/L) Standard Deviation 9.9750
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 24: ALT	0.463 Units per Liter (U/L) Standard Deviation 10.1470	2.224 Units per Liter (U/L) Standard Deviation 15.5979
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 8: AST	-0.525 Units per Liter (U/L) Standard Deviation 12.0147	0.144 Units per Liter (U/L) Standard Deviation 4.8584
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) Week 16: AST	-0.208 Units per Liter (U/L) Standard Deviation 12.6366	0.163 Units per Liter (U/L) Standard Deviation 5.4557

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.

Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=102 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=98 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 8: Total Bilirubin	0.639 micromole per liter (mcmol/L) Standard Deviation 2.5303	-0.131 micromole per liter (mcmol/L) Standard Deviation 2.9617
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 16: Total Bilirubin	1.476 micromole per liter (mcmol/L) Standard Deviation 3.4135	0.555 micromole per liter (mcmol/L) Standard Deviation 3.6679
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 24: Total Bilirubin	0.687 micromole per liter (mcmol/L) Standard Deviation 3.0396	0.254 micromole per liter (mcmol/L) Standard Deviation 3.1664
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 8: Direct Bilirubin	0.086 micromole per liter (mcmol/L) Standard Deviation 0.5495	-0.010 micromole per liter (mcmol/L) Standard Deviation 0.5998
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 16: Direct Bilirubin	0.154 micromole per liter (mcmol/L) Standard Deviation 0.6910	0.071 micromole per liter (mcmol/L) Standard Deviation 0.7628
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 24: Direct Bilirubin	0.109 micromole per liter (mcmol/L) Standard Deviation 0.5393	0.009 micromole per liter (mcmol/L) Standard Deviation 0.7612
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 8: Creatinine	-0.446 micromole per liter (mcmol/L) Standard Deviation 8.9118	-0.308 micromole per liter (mcmol/L) Standard Deviation 9.6489
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 16: Creatinine	0.624 micromole per liter (mcmol/L) Standard Deviation 9.7987	1.117 micromole per liter (mcmol/L) Standard Deviation 9.0316
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) Week 24: Creatinine	1.717 micromole per liter (mcmol/L) Standard Deviation 9.5267	0.336 micromole per liter (mcmol/L) Standard Deviation 8.4020

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24

Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.

Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.

Outcome measures

Measure	Group 1: Ustekinumab (IV Re-induction) n=102 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=98 Participants Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Sodium: Week 8	0.108 millimoles per liter (mmol/L) Standard Deviation 2.5714	-0.061 millimoles per liter (mmol/L) Standard Deviation 2.2375
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Sodium: Week 16	-0.165 millimoles per liter (mmol/L) Standard Deviation 2.2299	0.011 millimoles per liter (mmol/L) Standard Deviation 2.3370
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Sodium: Week 24	0.235 millimoles per liter (mmol/L) Standard Deviation 2.2928	-0.117 millimoles per liter (mmol/L) Standard Deviation 2.0454
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Potassium: Week 8	0.126 millimoles per liter (mmol/L) Standard Deviation 0.3596	0.050 millimoles per liter (mmol/L) Standard Deviation 0.3269
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Potassium: Week 16	0.105 millimoles per liter (mmol/L) Standard Deviation 0.3745	-0.002 millimoles per liter (mmol/L) Standard Deviation 0.3933
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Potassium: Week 24	0.067 millimoles per liter (mmol/L) Standard Deviation 0.3732	0.001 millimoles per liter (mmol/L) Standard Deviation 0.3185
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Chloride: Week 8	0.078 millimoles per liter (mmol/L) Standard Deviation 2.9136	-0.520 millimoles per liter (mmol/L) Standard Deviation 2.4714
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Chloride: Week 16	-0.299 millimoles per liter (mmol/L) Standard Deviation 2.4798	-0.489 millimoles per liter (mmol/L) Standard Deviation 2.5398
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Chloride: Week 24	0.160 millimoles per liter (mmol/L) Standard Deviation 2.4107	-0.481 millimoles per liter (mmol/L) Standard Deviation 2.2160
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) BUN/urea: Week 8	0.279 millimoles per liter (mmol/L) Standard Deviation 1.0050	0.248 millimoles per liter (mmol/L) Standard Deviation 1.0710
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) BUN/urea: Week 16	0.204 millimoles per liter (mmol/L) Standard Deviation 1.2812	0.029 millimoles per liter (mmol/L) Standard Deviation 1.2841
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) BUN/urea: Week 24	0.304 millimoles per liter (mmol/L) Standard Deviation 1.2031	0.179 millimoles per liter (mmol/L) Standard Deviation 1.0629
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Calcium: Week 8	0.022 millimoles per liter (mmol/L) Standard Deviation 0.0967	0.013 millimoles per liter (mmol/L) Standard Deviation 0.0968
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Calcium: Week 16	0.007 millimoles per liter (mmol/L) Standard Deviation 0.1010	0.007 millimoles per liter (mmol/L) Standard Deviation 0.1098
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Calcium: Week 24	0.008 millimoles per liter (mmol/L) Standard Deviation 0.1101	0.004 millimoles per liter (mmol/L) Standard Deviation 0.1109
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Phosphate: Week 8	0.005 millimoles per liter (mmol/L) Standard Deviation 0.2015	0.046 millimoles per liter (mmol/L) Standard Deviation 0.2024
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Phosphate: Week 16	0.006 millimoles per liter (mmol/L) Standard Deviation 0.1946	0.026 millimoles per liter (mmol/L) Standard Deviation 0.1905
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) Phosphate: Week 24	0.018 millimoles per liter (mmol/L) Standard Deviation 0.1612	0.021 millimoles per liter (mmol/L) Standard Deviation 0.1938

Adverse Events

Group 1: Ustekinumab (IV Re-induction)

Serious events: 9 serious events

Other events: 73 other events

Deaths: 1 deaths

Group 2: Ustekinumab (Continuous q8w SC Maintenance)

Serious events: 13 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 participants at risk Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 participants at risk Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Cardiac disorders Acute Myocardial Infarction	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Cardiac disorders Atrial Fibrillation	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Pain	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	2.8% 3/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Crohn's Disease	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	3.7% 4/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Ileal Stenosis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Small Intestinal Obstruction	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Small Intestinal Stenosis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Abdominal Abscess	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Anal Abscess	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Tooth Abscess	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Urinary Tract Infection	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Diabetes Mellitus	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Renal and urinary disorders Calculus Urinary	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Renal and urinary disorders Renal Atrophy	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Renal and urinary disorders Urethral Stenosis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.

Other adverse events

Measure	Group 1: Ustekinumab (IV Re-induction) n=108 participants at risk Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.	Group 2: Ustekinumab (Continuous q8w SC Maintenance) n=107 participants at risk Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36.
Blood and lymphatic system disorders Anaemia	2.8% 3/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Lymphopenia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Cardiac disorders Atrial Fibrillation	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Ear and labyrinth disorders Ear Pain	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Ear and labyrinth disorders Tinnitus	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Ear and labyrinth disorders Vertigo	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Eye disorders Eye Irritation	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Eye disorders Photophobia	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Eye disorders Uveitis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Discomfort	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Distension	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Mass	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Pain	4.6% 5/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	2.8% 3/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Pain Upper	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Abdominal Tenderness	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Anal Eczema	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Anal Fissure	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	3.7% 4/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Anal Fistula	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Anal Skin Tags	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Constipation	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Crohn's Disease	21.3% 23/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	27.1% 29/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Dyspepsia	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Eosinophilic Oesophagitis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Faecaloma	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Food Poisoning	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Gastrointestinal Inflammation	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Haematochezia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Haemorrhoids	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Nausea	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	3.7% 4/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Proctalgia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Stomatitis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Subileus	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Toothache	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Gastrointestinal disorders Vomiting	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Asthenia	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Chills	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Fatigue	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	2.8% 3/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Influenza Like Illness	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Injection Site Erythema	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Injection Site Mass	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
General disorders Pyrexia	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	3.7% 4/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Hepatobiliary disorders Cholestasis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Immune system disorders Seasonal Allergy	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Abscess Soft Tissue	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Anal Abscess	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Bronchitis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations COVID-19	11.1% 12/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	15.0% 16/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Clostridium Difficile Infection	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Conjunctivitis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Coronavirus Infection	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Enteritis Infectious	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Erythema Migrans	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Gastroenteritis	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	3.7% 4/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Gastroenteritis Viral	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Gastrointestinal Infection	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Herpes Zoster	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Infected Fistula	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Infection	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Influenza	3.7% 4/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Lower Respiratory Tract Infection	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Nasopharyngitis	2.8% 3/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	4.7% 5/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Otitis Externa	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Pharyngitis Streptococcal	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Pyelitis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Pyelonephritis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Sinusitis	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Upper Respiratory Tract Infection	4.6% 5/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Ureaplasma Infection	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Urinary Tract Infection	2.8% 3/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	2.8% 3/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Infections and infestations Vulvovaginal Candidiasis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Foot Fracture	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Injection Related Reaction	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Ligament Rupture	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Procedural Pain	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Tendon Rupture	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Vaccination Complication	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Aspartate Aminotransferase Increased	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Blood Creatinine Increased	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Blood Magnesium Decreased	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations C-Reactive Protein Increased	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	1.9% 2/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Gamma-Glutamyltransferase Increased	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Sars-Cov-2 Test Positive	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Vitamin D Decreased	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Investigations Weight Increased	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Dehydration	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Gout	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hypercholesterolaemia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hypoalbuminaemia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hypophosphataemia	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Iron Deficiency	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Vitamin D Deficiency	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Zinc Deficiency	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 3/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	3.7% 4/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Arthritis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Back Pain	3.7% 4/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Greater Trochanteric Pain Syndrome	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscle Contracture	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Neck Pain	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Pain in Jaw	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Rheumatic Disorder	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Musculoskeletal and connective tissue disorders Spondylitis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Nervous system disorders Carotid Arteriosclerosis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Nervous system disorders Dizziness	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Nervous system disorders Dizziness Postural	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Nervous system disorders Headache	7.4% 8/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	4.7% 5/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Nervous system disorders Migraine	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Nervous system disorders Ophthalmic Migraine	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Pregnancy, puerperium and perinatal conditions Pregnancy	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Psychiatric disorders Affective Disorder	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Psychiatric disorders Conversion Disorder	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Psychiatric disorders Depression	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Psychiatric disorders Insomnia	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Psychiatric disorders Restlessness	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Renal and urinary disorders Pelvi-Ureteric Obstruction	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Renal and urinary disorders Pollakiuria	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Reproductive system and breast disorders Cystocele	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Reproductive system and breast disorders Female Genital Tract Fistula	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Reproductive system and breast disorders Heavy Menstrual Bleeding	1.9% 2/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Reproductive system and breast disorders Pelvic Fluid Collection	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Reproductive system and breast disorders Scrotal Dermatitis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Asthma	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	5.6% 6/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Tonsillar Disorder	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Acne	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Dermal Cyst	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Eczema	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Erythema Nodosum	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	2.8% 3/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Intertrigo	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Pruritus	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Psoriasis	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Rash	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Skin and subcutaneous tissue disorders Urticaria	0.93% 1/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.00% 0/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Vascular disorders Deep Vein Thrombosis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Vascular disorders Hypertension	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
Vascular disorders Superficial Vein Thrombosis	0.00% 0/108 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.	0.93% 1/107 • From baseline (Week 0) up to Week 36 Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.

Additional Information

Senior Director GI Clinical Development

Janssen-Cilag Ltd.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER