A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 March 2025
• Main ID: NCT04991753
• Date of registration: 02/08/2021
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
• Scientific title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy
• Date of first enrolment: October 14, 2021
• Target sample size: 53
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04991753
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany, Poland, Spain, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Other: Placebo

Drug: Nipocalimab

Primary Outcome(s)

Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Percentage of Participants with TEAEs Leading to Discontinuation of Study Intervention [Time Frame: Up to 24 weeks]

Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 [Time Frame: Baseline, up to Week 12]

Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12 [Time Frame: Week 12]

Percentage of Participants who Achieve ACR50 at Week 12 [Time Frame: Week 12]

Percentage of Participants who Achieve American College of Rheumatology (ACR) 20 at Week 12 [Time Frame: Week 12]

Percentage of Participants with Adverse Events of Special interests (AESIs) [Time Frame: Up to 24 weeks]

Percentage of Participants with Change from Baseline in Clinical Laboratory Abnormalities Over Time [Time Frame: Up to 24 weeks]

Percentage of Participants with Antibodies to Nipocalimab (Anti-drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) [Time Frame: Up to Week 18]

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to 24 weeks]

Serum Concentration of Nipocalimab Over Time [Time Frame: Up to Week 18]

Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) [Time Frame: Up to 24 weeks]

Percentage of Participants who Achieve ACR90 at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving DAS28-CRP Remission at Week 12 [Time Frame: Week 12]

Percentage of Participants who Achieve ACR70 at Week 12 [Time Frame: Week 12]

Percentage of Participants with Change from Baseline in Vital Signs Abnormalities Over Time [Time Frame: Up to 24 weeks]

Secondary ID(s)

2021-000510-42

80202135ARA2001

CR109058

Source(s) of Monetary Support

Please refer to primary and secondary sponsors