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-PL

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

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 screening
- 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
- 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

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

Name	Time	Method

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