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

NCT04991753 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR10905880202135ARA20012021-000510-42
• Study Type: interventional
• Target: 53
• Locations: 5 countries
• Sites: 28

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).

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12

  Change from baseline in DAS28-CRP at Week 12 were reported. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity, and C-reactive protein (CRP; in milligrams per liter \[mg/L\]). The set of 28 joint count was based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis.

  Baseline (Week 0), Week 12

Secondary Outcomes (11)

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 at Week 12

  Week 12

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 at Week 12

  Week 12

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 at Week 12

  Week 12

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 at Week 12

  Week 12

• Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12

  Week 12

Study Arms (2)

Group 1: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Group 2: Nipocalimab

EXPERIMENTAL

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

Drug: Nipocalimab

Interventions

Placebo OTHER

Placebo infusion will be administered intravenously.

Group 1: Placebo

Nipocalimab DRUG

Nipocalimab infusions will be administered intravenously.

Also known as: JNJ-80202135, M281

Group 2: Nipocalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (28)

Arizona Arthritis & Rheumatology Associates PC

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Tucson, Arizona, 85704, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

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

Poway, California, 92064, United States

Location

TriWest Research Associates, LLC

San Diego, California, 92108, United States

Location

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28210, United States

Location

STAT Research, Inc.

Vandalia, Ohio, 45377, United States

Location

Low Country Rheumatology PA

Summerville, South Carolina, 29486, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Accurate Clinical Research, Inc.

Houston, Texas, 77089, United States

Location

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States

Location

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

Location

Rheumazentrum Ratingen

Ratingen, 40878, Germany

Location

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

NZOZ Lecznica Mak-Med sc

Nadarzyn, 05-830, Poland

Location

Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj

Poznan, 61 397, Poland

Location

Centrum Medyczne AMED Targowek

Warsaw, 03 291, Poland

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Do Meixoeiro

Vigo, 36214, Spain

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Kings College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

North Tyneside General Hospital

Newcastle, NE29 8NH, United Kingdom

Location

Haywood Hospital

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38942592 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Director Rheumatology
• Organization: Janssen Research & Development

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 5, 2021
• Study Start: October 14, 2021
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (13); DE (2); PL (4); ES (5); GB (4)