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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sjogren's Syndrome

In brief

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

Key facts

Study ID

NCT04968912

Run by

Janssen Research & Development, LLC

People needed

163

Starts

2021-09-21

Expected to finish

2023-11-30

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis and Rheumatology Research PLLC — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
• St. Jude Heritage Medical Group — Fullerton, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Colorado Arthritis Associates — Denver, Colorado, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Rheumatology Associates Of South Florida — Boca Raton, Florida, United States
• Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
• Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• University of Florida Health Jacksonville — Jacksonville, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Clinical Investigation Specialists — Gurnee, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• St. Paul Rheumatology P A — Eagan, Minnesota, United States
• North Mississippi Medical Clinics — Tupelo, Mississippi, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Columbia Arthritis Center — Columbia, South Carolina, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Dr. Ramesh Gupta — Memphis, Tennessee, United States
• Austin Regional Clinic — Austin, Texas, United States
• Trinity Clinical Research, LLC — Carrollton, Texas, United States
• Anniston Medical Clinic — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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