A Study of Combination Therapy With Guselkumab and Golimu... | NCT05242471

NCT05242471

ID	Type	Description
78934804CRD2001	Other Identifier	Janssen Research & Development, LLC
2021-003314-39	EudraCT Number
2023-504741-32-00	Registry Identifier	EUCT number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Placebo	Placebo Comparator	Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Drug: Placebo
Group 2: Guselkumab	Experimental	Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: Guselkumab
Group 3: Golimumab	Experimental	Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.	Biological: Golimumab
Group 4: JNJ-78934804 (High-dose)	Experimental	Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.

Name	Type	Description	Arm Group Labels	Other Names
Guselkumab	Biological	Guselkumab will be administered as subcutaneous injection.	Group 2: Guselkumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Clinical Remission at Week 48	Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).	Week 48
Percentage of Participants with Endoscopic Response at Week 48	Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading.	Week 48

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48	Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.	Week 48
Percentage of Participants with Endoscopic Remission at Week 48

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Liver Center		Birmingham	Alabama	35233	United States
Del Sol Research Management, LLC

IPD Sharing Statement Module

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases