A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

• Ustekinumab Dose Based on BSA and Body Weight (Drug), also known as STELARA: As per BSA and body weight Ustekinumab will be administered SC and IV.
• Matching Placebo (Drug): Placebo will be administered subcutaneously.

Primary outcomes

• Global: Percentage of Participants With Clinical Remission at Induction Week 8 [Induction Week 8]: Clinical remission was defined by Mayo subscores as: a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Induction Period: From induction Week 0 (Study Week 8) up to induction Week 8; Maintenance Period: From Maintenance Week 0 up to Maintenance Week 44 (Study Week 52)]: Number of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AE occurring at or after the initial administration of study intervention.
• Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) [Induction Period: From induction Week 0 (Study Week 8) up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)]: Number of participants with TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. TESAEs were defined as any SAE occurring at or after the initial administration of study intervention.
• Number of Participants With AEs Leading to Discontinuation of Study Intervention [Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 40 (Study Week 48)]: Number of participants with AEs leading to discontinuation of study intervention were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
• Number of Participants With Adverse Events of Special Interest (AESIs) [Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)]: An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. AESI were defined as any newly identified malignancy, or case of active Tuberculosis (TB), or opportunistic infection occurring after the first administration of study intervention.
• Number of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology [Induction Period: From Induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)]: Number of participants with abnormalities in clinical laboratory parameters with increased or decreased hematology parameters such as hemoglobin, anemia, lymphocyte count, platelet count, leukocytosis, white blood cells, were reported. Grades 0-4 were based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), where Grade 0-Normal, Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe or medically significant but not immediately life-threatening, Grade 4- Life-threatening consequences. Higher grades showed severe abnormality. Only abnormalities where at least one participant had data are reported.
• Number of Participants With Abnormalities in Clinical Laboratory Parameters: Chemistry [Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)]: Number of participants with abnormalities in clinical laboratory parameters with increased or decreased chemistry parameters such as Alanine Aminotransferase, Aspartate Aminotransferase, Hypoalbuminemia, Alkaline Phosphatase, Blood Bilirubin, Creatinine, Gamma-Glutamyl Transferase, Hyperkalemia, Hypokalemia, Hypernatremia, Hyponatremia were reported. Grades 0-4 were based on NCI-CTCAE version 5.0 where Grade 0-Normal, Grade 1- Mild, Grade 2- Moderate, Grade 3- Severe or medically significant but not immediately life-threatening, Grade 4- Life-threatening consequences. Higher grades showed severe abnormality. Only abnormalities where at least one participant had data are reported.
• Number of Participants With Reactions Temporally Associated With Intravenous (IV) Infusion (Induction Period) and Subcutaneous (SC) Injection-Site Reactions (Maintenance Period) [Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)]: Number of participants with reactions temporally associated with intravenous (IV) infusion (Induction Period) and subcutaneous (SC) injection-site reactions (Maintenance Period) were reported.
• Serum Ustekinumab Concentrations [Induction Period: Week I-0, 1-hour pre and post infusion; Week I-2, I-4, and Week I-8; Maintenance Period: Week M-4, M-8, M-12, M-16, M-24, M-32, M-36, and M-44]: Serum ustekinumab concentrations were reported. PK= pharmacokinetic.

Secondary outcomes

• Percentage of Participants With Clinical Response at Induction Week 8 [Induction Week 8]: Clinical response was defined as a decrease from induction baseline in the Modified Mayo score by >=30 percent (%) and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Symptomatic Remission at Induction Week 8 [Induction Week 8]: Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen), where the stool frequency subscore had not increased from induction baseline. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Clinical Remission at Induction Week 8 as Assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) Score [Induction Week 8]: Percentage of participants with clinical remission at Induction Week 8 as assessed by PUCAI score was reported. Clinical remission as measured by the PUCAI score was a PUCAI score <10. PUCAI score was intended for pediatric participants with UC. PUCAI consisted of the following 6 subscores with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only \[in less than 50 % of stools\] =10, small amount with most stools =20, large amount \[>50% of the stool content\] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI total score ranges from 0 to 85, with higher scores indicating greater disease severity.
• Percentage of Participants With Endoscopic Improvement at Induction Week 8 [Induction Week 8]: Endoscopic improvement was defined as a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.
• Percentage of Participants With Histologic-Endoscopic Mucosal Improvement at Induction Week 8 [Induction Week 8]: Histologic-endoscopic mucosal improvement based on Geboes score (GS) was defined as achieving a combination of histologic improvement (neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions, ulcerations or granulation tissue according to Geboes grading system) and endoscopic improvement (Mayo subscore of 0 or 1 with no friability in endoscopy). GS has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils, eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Higher score, more severe disease. Modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore determined during central review, each subscore graded from 0 (normal) to 3 (severe). Individual subscores were summed up to give total modified Mayo score range of 0 (normal) to 9 (severe disease), higher score=more severe disease.
• Percentage of Participants With Clinical Remission at Maintenance Week 44 [Maintenance Week 44 (Study Week 52)]: Clinical remission was defined by Mayo subscores as: a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Symptomatic Remission at Maintenance Week 44 [Maintenance Week 44 (Study Week 52)]: Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Clinical Remission at Maintenance Week 44 as Assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) Score [Maintenance Week 44 (Study Week 52)]: Percentage of participants with clinical remission at Maintenance Week 44 as assessed by PUCAI score was reported. Clinical remission as measured by the PUCAI score was a PUCAI score <10. PUCAI score was intended for pediatric participants with UC. PUCAI consisted of the following 6 subscores with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only \[in less than 50% of stools\] =10, small amount with most stools =20, large amount \[>50% of the stool content\] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, >8 =15); nocturnal bowel movement (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI total score ranges from 0 to 85, with higher scores indicating greater disease severity.
• Percentage of Participants With Endoscopic Improvement at Maintenance Week 44 [Maintenance Week 44 (Study Week 52)]: Endoscopic improvement was defined as a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. Modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), higher scores indicated more severe disease.
• Percentage of Participants With Corticosteroid-free Clinical Remission at Maintenance Week 44 [Maintenance Week 44 (Study Week 52)]: Corticosteroid-free clinical remission was defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline; and not receiving corticosteroids for at least 90 days prior to Week M-44. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Clinical Remission at Maintenance Week 44 and Not Receiving Corticosteroids for At Least 90 Days Prior to Maintenance Week 44 Among Participants Who Received Corticosteroids at Induction Week 0 [Maintenance Week 44 (Study Week 52)]: Corticosteroid-free clinical remission was defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline; and not receiving corticosteroids for at least 90 days prior to Week M-44. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Clinical Remission at Week 44 (Maintenance Period) Who Had Clinical Remission at Induction Week 8 [Maintenance Week 44 (Study Week 52)]: Clinical remission was defined by Mayo subscores as: a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. Baseline was defined as the last observation prior to or at the time of the first study intervention.
• Percentage of Participants With Histologic-Endoscopic Mucosal Improvement at Maintenance Week 44 [Maintenance Week 44 (Study Week 52)]: Histologic-endoscopic mucosal improvement based on Geboes Score: achieving a combination of histologic improvement (neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions, ulcerations or granulation tissue according to Geboes grading system), endoscopic improvement (Mayo sub-score of 0 or 1 with no friability in endoscopy). GS has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils, eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; Grade 5, erosions or ulceration. Higher score indicated more severe disease. Modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding, endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give total modified Mayo score range of 0 (normal) to 9 (severe disease), higher scores indicated more severe disease.

Sex: All, ages: 2 Years to 17 Years

Inclusion Criteria:

* Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
* Must have had UC diagnosed prior to screening
* Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy
* A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for >= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention
* Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration

Exclusion Criteria:

* Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
* Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
* Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening
* Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly
* Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

Participant flow

Outcome results

• Global: Percentage of Participants With Clinical Remission at Induction Week 8 (Primary), Number, Percentage of participants: Induction Period: Ustekinumab Intravenous (IV) 25 (17.9 to 33.8)
• Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 59; Maintenance Period: Ustekinumab SC q12w 52; Maintenance Period: Ustekinumab SC q8w 48
• Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 6; Maintenance Period: Ustekinumab SC q12w 2; Maintenance Period: Ustekinumab SC q8w 5
• Number of Participants With AEs Leading to Discontinuation of Study Intervention (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 2; Maintenance Period: Ustekinumab SC q12w 3; Maintenance Period: Ustekinumab SC q8w 2
• Number of Participants With Adverse Events of Special Interest (AESIs) (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 0; Maintenance Period: Ustekinumab SC q12w 1; Maintenance Period: Ustekinumab SC q8w 0
• Number of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 102; Maintenance Period: Ustekinumab SC q12w 54; Maintenance Period: Ustekinumab SC q8w 53
• Number of Participants With Abnormalities in Clinical Laboratory Parameters: Chemistry (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 107; Maintenance Period: Ustekinumab SC q12w 52; Maintenance Period: Ustekinumab SC q8w 47
• Number of Participants With Reactions Temporally Associated With Intravenous (IV) Infusion (Induction Period) and Subcutaneous (SC) Injection-Site Reactions (Maintenance Period) (Primary), Count of participants, Participants: Induction Period: Ustekinumab Intravenous (IV) 3; Maintenance Period: Ustekinumab SC q12w 0; Maintenance Period: Ustekinumab SC q8w 1
• Serum Ustekinumab Concentrations (Primary), Mean, micrograms per milliliter: Induction Period: Ustekinumab Intravenous (IV) 0.020 +/- 0.1194; Maintenance Period: Ustekinumab SC q12w ; Maintenance Period: Ustekinumab SC q8w
• Percentage of Participants With Clinical Response at Induction Week 8 (Secondary), Number, Percentage of Participants: Induction Period: Ustekinumab Intravenous (IV) 67.0 (57.8 to 75.0)
• Percentage of Participants With Symptomatic Remission at Induction Week 8 (Secondary), Number, Percentage of Participants: Induction Period: Ustekinumab Intravenous (IV) 48.2 (39.2 to 57.4)
• Percentage of Participants With Clinical Remission at Induction Week 8 as Assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) Score (Secondary), Number, Percentage of participants: Induction Period: Ustekinumab Intravenous (IV) 38.4 (29.9 to 47.6)
• Percentage of Participants With Endoscopic Improvement at Induction Week 8 (Secondary), Number, Percentage of participants: Induction Period: Ustekinumab Intravenous (IV) 30.4 (22.6 to 39.4)
• Percentage of Participants With Histologic-Endoscopic Mucosal Improvement at Induction Week 8 (Secondary), Number, Percentage of participants: Induction Period: Ustekinumab Intravenous (IV) 19.6 (13.3 to 28.0)
• Percentage of Participants With Clinical Remission at Maintenance Week 44 (Secondary), Number, Percentage of Participants: Maintenance Period: Ustekinumab SC q12w 32.5 (20.1 to 48.0); Maintenance Period: Ustekinumab SC q8w 48.7 (33.9 to 63.8)
• Percentage of Participants With Symptomatic Remission at Maintenance Week 44 (Secondary), Number, Percentage of Participants: Maintenance Period: Ustekinumab SC q12w 57.5 (42.2 to 71.5); Maintenance Period: Ustekinumab SC q8w 74.4 (58.9 to 85.4)
• Percentage of Participants With Clinical Remission at Maintenance Week 44 as Assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) Score (Secondary), Number, Percentage of Participants: Maintenance Period: Ustekinumab SC q12w 57.5 (42.2 to 71.5); Maintenance Period: Ustekinumab SC q8w 71.8 (56.2 to 83.5)
• Percentage of Participants With Endoscopic Improvement at Maintenance Week 44 (Secondary), Number, Percentage of Participants: Maintenance Period: Ustekinumab SC q12w 32.5 (20.1 to 48.0); Maintenance Period: Ustekinumab SC q8w 48.7 (33.9 to 63.8)
• Percentage of Participants With Corticosteroid-free Clinical Remission at Maintenance Week 44 (Secondary), Number, Percentage of participants: Maintenance Period: Ustekinumab SC q12w 32.5 (20.1 to 48.0); Maintenance Period: Ustekinumab SC q8w 48.7 (33.9 to 63.8)
• Percentage of Participants With Clinical Remission at Maintenance Week 44 and Not Receiving Corticosteroids for At Least 90 Days Prior to Maintenance Week 44 Among Participants Who Received Corticosteroids at Induction Week 0 (Secondary), Number, Percentage of participants: Maintenance Period: Ustekinumab SC q12w 41.2 (21.6 to 64.0); Maintenance Period: Ustekinumab SC q8w 56.3 (33.2 to 76.9)
• 2 more outcome measures not shown.

Adverse events

Time frame: All-cause mortality: From screening (-6 weeks) up to Week I-8 (Induction Period); from Week M-0 (Study Week 8) up to Week M-44(Study Week 52) (Maintenance period); Serious and other AEs: From Week I-0 up to Week I-8 (Induction Period); from Week M-0 (Study Week 8) up to Week M-44 (Study Week 52) (Maintenance period)

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2022-05-25)
• Statistical Analysis Plan (PDF, 2025-04-04)

• Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC

NIH grants: 2023, 2019