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Nipocalimab in Moderate to Severe Sjogren's Disease

NCT06741969

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Sjogrens Syndrome

Interventions: Nipocalimab, Placebo, Standard of care treatment

Countries: United States, Argentina, Austria, Brazil, Bulgaria, Canada, China, Czechia

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:-

* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
* Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
* Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
* Total ClinESSDAI score greater than or equal to (\>=) 5 at screening
* Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization

Exclusion Criteria:

* Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \[e.g.\], monoclonal antibodies, intravenous immunoglobulin)
* Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Locations (254)

Chula Vista, California, United States
Fullerton, California, United States
La Palma, California, United States
Monterey Park, California, United States
San Leandro, California, United States
Santa Monica, California, United States
Tustin, California, United States
Upland, California, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
Suwanee, Georgia, United States
Skokie, Illinois, United States
Willowbrook, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Saint Clair Shores, Michigan, United States
Eagan, Minnesota, United States
Kansas City, Missouri, United States
Voorhees Township, New Jersey, United States
New York, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Salisbury, North Carolina, United States
Fairborn, Ohio, United States
Oklahoma City, Oklahoma, United States
+ 224 more on CT.gov