A Study of Nipocalimab in Adults With Primary Sjogren's S... | NCT04968912

ID	Type	Description	Link
80202135SJS2001	Other Identifier	Janssen Research & Development, LLC
2021-000665-32	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Placebo	Placebo Comparator	Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 22 along with standard of care treatments ([including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues], and/or one immunomodulator with or without low-dose glucocorticosteroids).	Other: Placebo Drug: Standard of Care Treatment
Group 2: Nipocalimab Dose 1	Experimental	Participants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments ([including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues], and/or one immunomodulator with or without low-dose glucocorticosteroids).	Drug: Nipocalimab Drug: Standard of Care Treatment
Group 3: Nipocalimab Dose 2	Experimental	Participants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments ([including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues], and/or one immunomodulator with or without low-dose glucocorticosteroids).	Drug: Nipocalimab Drug: Standard of Care Treatment

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Placebo infusion will be administered intravenously.	Group 1: Placebo

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 24	The clinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome. 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.	Baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24	The ESSPRI is a patient-reported assessment of the severity of dryness, fatigue, and pain associated with primary Sjogren's Syndrome. Participants are asked to rate the severity of dryness, fatigue and pain over the past 2 weeks on a numeric rating scale (NRS), ranging from 0 "no symptoms (dryness, fatigue or pain)" to 10 "maximal imaginable (dryness, fatigue, pain)". A global score, calculated as the mean of the 3 domain scores, ranges from 0 to 10, with higher scores reflecting greater (worse) symptom severity.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time of screening (results either obtained during screening or documented in the participant's medical history are acceptable to fulfill these criteria for Schirmer's test, unstimulated salivary flow test, ocular staining score, or labial salivary gland biopsy), and was diagnosed with pSS no less than 26 weeks prior to screening
At screening is seropositive for antibodies to pSS-associated antigen A (Ro/Sjogren's syndrome-related antigen A [SSA])
Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (>=) 6
At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains
It is recommended to be up to date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. It is strongly recommended that participants will have completed a locally-approved (or emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccination regimen at least 2 weeks prior to study related visits or procedures. Study participants should, follow applicable local vaccine labelling, guidelines, and standards-of-care for participants receiving immune-targeted therapy will be followed when determining an appropriate interval between vaccination and study enrollment

Exclusion Criteria:

Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
Has any unstable or progressive manifestation of pSS that is likely to warrant escalation in therapy beyond permitted background medications and/or has severely active pSS
Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
Has Sjogren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition (for example, rheumatoid arthritis [RA], systemic lupus erythematosus [SLE], scleroderma, inflammatory bowel disease [IBD]) is the primary diagnosis or has clinical manifestations that, in the opinion of the investigator, or the sponsor or sponsor's representative, are likely to interfere with the investigator's ability to assess pSS manifestations

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

Facility	Status	City	State	ZIP	Country	Contacts
Anniston Medical Clinic		Anniston	Alabama	36207	United States
Arizona Arthritis and Rheumatology Research PLLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42084498	Derived	Yu F, Myshkin E, Nguyen B, Bobadilla Mendez C, Cossu M, Fei K, Wang Q, Hubbard JJ, Campbell K, Ramchandren S, Rojo Cella R, Edwards R, Taylor PC, Gottenberg JE, Noaiseh G, Vu T, Antozzi C, Winthrop KL, Cuff CA, Loza MJ, Dimitrova D, Gao S. Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials. Hum Vaccin Immunother. 2026 Dec;22(1):2664331. doi: 10.1080/21645515.2026.2664331. Epub 2026 May 5.
41284548

IPD Sharing Statement Module

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