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

NCT ID: NCT04991753

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-14
• Study Completion Date: 2022-08-10

Brief 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).

Detailed Description

RA is a chronic autoimmune inflammatory disorder of unknown etiology that occurs in approximately 1 percent (%) of the population. Nipocalimab (also referred to as JNJ-80202135 and M281) is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable (Fc) receptor (FcRn). Nipocalimab has a unique mechanism of action whereby it blocks the IgG binding site on endogenous FcRn and is expected to decrease pathogenic IgG antibody concentrations. A significant involvement of pathogenic IgG antibodies has been demonstrated in autoimmune diseases including RA. The primary hypothesis is that treatment with nipocalimab intravenously (IV) every 2 weeks (q2w) is superior to placebo in participants with moderate to severe active rheumatoid arthritis (RA) as assessed by the mean change from baseline in the disease activity index score 28 using C-reactive Protein (DAS28-CRP) at Week 12. The study consists of a Screening Period (less than or equal to [<=] 6 Weeks), Double-blind Treatment Period (12 Weeks), and a Safety Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory safety tests (hematology, chemistry, and lipid profile), vital signs, and physical examination. The total duration of the study is up to 24 weeks.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Placebo

Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo infusion will be administered intravenously.

Group 2: Nipocalimab

Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab infusions will be administered intravenously.

Interventions

Placebo

Placebo infusion will be administered intravenously.

Intervention Type: OTHER

Nipocalimab

Nipocalimab infusions will be administered intravenously.

Intervention Type: DRUG

Other Intervention Names

JNJ-80202135; M281

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Arizona Arthritis & Rheumatology Associates PC

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Tucson, Arizona, United States

Desert Medical Advances

Palm Desert, California, United States

Arthritis Care and Research Center Inc.: Smitha Reddy, MD

Poway, California, United States

TriWest Research Associates, LLC

San Diego, California, United States

Inland Rheumatology Clinical Trials, Inc.

Upland, California, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

STAT Research, Inc.

Vandalia, Ohio, United States

Low Country Rheumatology PA

Summerville, South Carolina, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

Southwest Rheumatology Research LLC

Mesquite, Texas, United States

Hamburger Rheuma Forschungszentrum II

Hamburg, , Germany

Rheumazentrum Ratingen

Ratingen, , Germany

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

NZOZ Lecznica Mak-Med sc

Nadarzyn, , Poland

Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

Poznan, , Poland

Centrum Medyczne AMED Targowek

Warsaw, , Poland

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. Univ. de Basurto

Bilbao, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Hosp. Do Meixoeiro

Vigo, , Spain

Western General Hospital

Edinburgh, , United Kingdom

Kings College Hospital NHS Trust

London, , United Kingdom

North Tyneside General Hospital

Newcastle, , United Kingdom

Haywood Hospital

Stoke-on-Trent, , United Kingdom

Countries

United States; Germany; Poland; Spain; United Kingdom

References

Taylor PC, Schett G, Huizinga TW, Wang Q, Ibrahim F, Zhou B, Liva SG, Shaik JSB, Xiong Y, Leu JH, Panchakshari RA, Loza MJ, Ma K, Dhatt H, Rojo Cella R, Karyekar CS, Cuff CA, Gao S, Fei K. Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study. RMD Open. 2024 Jun 28;10(2):e004278. doi: 10.1136/rmdopen-2024-004278.

Reference Type: DERIVED

PMID: 38942592 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

80202135ARA2001

Identifier Type: OTHER

Identifier Source: secondary_id

2021-000510-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR109058

Identifier Type: -

Identifier Source: org_study_id