A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR Jr)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Colitis, Ulcerative

Treatments: Drug: Guselkumab Subcutaneous; Drug: Guselkumab Intravenous

Study type: Interventional

Funder types: Industry

Identifiers

NCT06260163

CNTO1959PUC3001 (Other Identifier)

2022-502238-22-00 (Registry Identifier)

CR109251

2022-001285-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
• A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
• Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
• Medically stable based on 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
• Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids

Exclusion criteria

• Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
• Presence of a stoma
• Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
• Have severe colitis or have evidence of Crohn's Disease (CD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 5 patient groups

Open-label Induction Phase: Guselkumab Intravenously (IV)

Experimental group

Description:

Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.

Treatment:

Drug: Guselkumab Intravenous

Open-label Induction Phase: Guselkumab Subcutaneously (SC)

Experimental group

Description:

Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.

Treatment:

Drug: Guselkumab Subcutaneous

Double-blind Maintenance Phase: Guselkumab Dose Regimen 1

Experimental group

Description:

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.

Treatment:

Drug: Guselkumab Subcutaneous

Double-blind Maintenance Phase: Guselkumab Dose Regimen 2

Experimental group

Description:

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.

Treatment:

Drug: Guselkumab Subcutaneous

Open-label Maintenance Phase: Guselkumab SC

Experimental group

Description:

Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.

Treatment:

Drug: Guselkumab Subcutaneous