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Purpose

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Group 1: Placebo 		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
    Placebo infusion will be administered intravenously.
  • Drug: Standard of Care Treatment
    Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Experimental
Group 2: Nipocalimab Dose 1 		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
    Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
    Other names:
    • JNJ-80202135
    • M281
  • Drug: Standard of Care Treatment
    Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Experimental
Group 3: Nipocalimab Dose 2 		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
    Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
    Other names:
    • JNJ-80202135
    • M281
  • Drug: Standard of Care Treatment
    Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.

More Details

Status
Completed
Sponsor
Janssen Research & Development, LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.