Phase 2
Completed N=53
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT04991753 ↗
Enrolled (actual)
53
Serious AEs
5.7%
Results posted
Aug 2025
Primary outcomePrimary: Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 — -0.58; -1.03 Score on a scale — p==0.224
Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 |
-0.58; -1.03 | =0.224 |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12 |
20.0; 45.5 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12 |
5.0; 15.2 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12 |
0; 12.1 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12 |
0; 6.1 | — |
| SECONDARY Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12 |
10.0; 21.2 | — |
| SECONDARY Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Low Disease Activity (LDA) European League Against Rheumatism (EULAR) at Week 12 |
10.0; 21.2 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 |
-0.21; -0.42 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
60.0; 81.8 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) |
0; 9.1 | — |
| SECONDARY Percentage of Participants With AEs Leading to Discontinuation of Study Intervention |
30.0; 18.2 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) |
0; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA for at least 3 months before screening
- Has moderate to severe active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints out of the 66/68-swollen and tender joint count at the time of screening and at baseline
- Is positive for anti-citrullinated protein antibodies (ACPA) and/or rheumatoid factor (RF) at screening
- Screening C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory
- A woman of childbearing potential must have a negative highly sensitive urine pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine (beta-hCG) pregnancy test at Week 0 prior to administration of study intervention
Exclusion Criteria
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before the first administration of study intervention or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first administration of study intervention)
- Is (anatomically or functionally) asplenic
- Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening
- Has other known inflammatory diseases that might confound the evaluations of benefit from nipocalimab therapy, including but not limited to ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Lyme disease
- Is currently taking immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics
Data sourced from ClinicalTrials.gov (NCT04991753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.