Nipocalimab in Moderate to Severe Sjogren's Disease | NCT06741969

NCT06741969

ID	Type	Description	Link
80202135SJS3001	Other Identifier	Janssen Research & Development, LLC
2024-513965-38-00	Registry Identifier	EUCT number

Status Module

Oversight Module

Description 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
Nipocalimab	Experimental	Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.	Drug: Nipocalimab Drug: Standard of care treatment
Placebo	Placebo Comparator	Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.	Drug: Placebo Drug: Standard of care treatment

Name	Type	Description	Arm Group Labels	Other Names
Nipocalimab	Drug	Nipocalimab SC.	Nipocalimab	JNJ-80202135, JNJ-86507083, M281

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48	ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.	Baseline to Week 48

Secondary Outcomes

Measure	Description	Time Frame
Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48	The ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with Sjogren's syndrome.	Baseline to Week 48
Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Clinical Research Center		Chula Vista	California	91910	United States
Providence Medical Foundation

IPD Sharing Statement Module

Ancestor Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D014987	Xerostomia
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D015352	Dry Eye Syndromes
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases