A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

Phase 1

Conditions: Primary Sjogren's Syndrome
MedDRA version: 21.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2021-000665-32-PT

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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, and was diagnosed with pSS no less than 26 weeks prior to screenig
- At screening is seropositive for antibodies to pSS-associated antigen A Ro/sjogren's syndrome-related antigen [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 that participants are up to date on all age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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
- clinESSDAI pulmonary domain score greater than (>) 6
- 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 (that is, 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of nipocalimab in participants with primary Sjogren’s syndrome<br>(pSS) versus placebo<br>;Secondary Objective: - To evaluate the safety of nipocalimab<br>treatment versus placebo in participants with<br>pSS<br><br>- To evaluate the pharmacokinetics (PK) and<br>immunogenicity of nipocalimab in<br>participants with pSS<br><br>- To evaluate the effect of nipocalimab versus<br>placebo on levels of serum biomarkers related<br>to pSS;Primary end point(s): Change from baseline in Clinical European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (clinESSDAI) score at Week 24;Timepoint(s) of evaluation of this end point: Baseline to week 24

Secondary Outcome Measures