Sjogrens Syndrome Musculoskeletal Diseases
Conditions
Interventions
Participants will be randomly assigned via an online tool to one of the 2 identical studies (conducted under this single protocol).
The study will consist of:
1. Screening period (up to Week 6)
2.
Sponsors
Janssen Research & Development, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory tests performed at screening 2. Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria 3. Seropositive for antibodies to Ro/SSA at screening 4. Total ClinESSDAI score greater than or equal to (>=) 5 at screening 5. 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
Exclusion criteria: 1. 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 2. Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation 3. 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 4. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin) 5. Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Minimal Clinically Important Improvement is measured using ClinESSDAI Score from Baseline to Week 48 2. Systemic disease activity in Participants with High Immunoglobulin (IgG) Levels at Baseline is measured using ClinESSDAI Score from baseline to Week 48 3. Systemic disease activity is measured ClinESSDAI Score from Baseline to Week 8 4. Glandular function change is measured using Stimulated Salivary Flow Rate from Baseline in at Week 48 5. Dryness symptoms will be measured using the Sjogren’s Symptoms Dryness Score from Baseline to Week 48 6. Joint pain will be measured using the Sjogren’s Symptoms Joint Pain Score from Baseline to Week 48 7. Severity of dryness, fatigue and pain associated with primary Sjogren’s Syndrome will be measured using the EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) Score from Baseline to Week 48 8. Fatigue is measured using the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score from Baseline to Week 48 | — |
Countries
Argentina, Austria, Brazil, Bulgaria, China, Denmark, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Portugal, Romania, Spain, Taiwan, United Kingdom
Contacts
Public ContactFarrah Reid
Outcome results
None listed