A Study of Ustekinumab in Pediatric Participants With Mod... | NCT04630028

ID	Type	Description
CNTO1275PUC3001	Other Identifier	Janssen Research & Development, LLC
2019-004224-38	EudraCT Number
2023-504977-19-00	Registry Identifier	EUCT number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Induction Period (I): Ustekinumab	Experimental	All participants will receive a single intravenous (IV) administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square [mg/m^2]) or weight-tiered induction dose (milligram per kilogram [mg/kg]).	Drug: Ustekinumab Dose Based on BSA and Body Weight
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)	Experimental	Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.	Drug: Ustekinumab Dose Based on BSA and Body Weight Drug: Matching Placebo
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)	Experimental	Participants will receive SC administration of ustekinumab every 12 weeks (q12w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.	Drug: Ustekinumab Dose Based on BSA and Body Weight Drug: Matching Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ustekinumab Dose Based on BSA and Body Weight	Drug	As per BSA and body weight Ustekinumab will be administered SC and IV.	Induction Period (I): Ustekinumab Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit	Clinical remission is defined as 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.	Week 8
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 74 weeks
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability	SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.	Up to 74 weeks
Number of Participants with AEs Leading to Discontinuation of Study Intervention	Number of Participants with discontinuation of study intervention due to an AE, infections, injection-site reactions, and AEs during or within 1 hour of an infusion will be reported.	Up to 74 weeks
Number of Participants with AEs of Special Interest (AESI) as a Measure of Safety and Tolerability	AESI of any newly identified malignancy, case of active tuberculosis (TB), or opportunistic infection occurring after the first administration of study intervention(s) in participants will be reported.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Clinical Response at I-8 Visit	Clinical response is defined as decrease from baseline in the modified Mayo score by >= 30 percent (%) and >=2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.	Week 8

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nemours DuPont Hospital for Children		Wilmington	Delaware	19803	United States
Children's Center for Digestive Health Care

IPD Sharing Statement Module

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Term
D014894	Weights and Measures
D000069549	Ustekinumab

ID	Term
D008919	Investigative Techniques
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins