A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Myositis Clinical Trial

— SPIREA  

Official title:

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379634
• Other study ID #: CR109210
• Secondary ID: 2021-005202-9880
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2022
• Est. completion date: October 28, 2027

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).

Description:

IIM is considered as a group of rare diseases that is characterized by common features of insidious painless, proximal skeletal muscle weakness, low endurance, and elevated serum muscle enzyme levels. Due to muscle weakness and progressive muscular atrophy, decreasing endurance, internal organ involvement (mainly given the pulmonary, gastrointestinal and cardiac manifestations) and limited therapeutic options, IIM often leads to physical disability and decreased quality of life. Nipocalimab is a fully human aglycosylated immunoglobulin G1 (IgG1) monoclonal antibody (mAb) designed to selectively bind, saturate, and block the immunoglobulin G (IgG) binding site on the endogenous neonatal fragment crystallizable receptor (FcRn) that binds, salvages, and recycles IgG into circulation or transport IgG across the placenta, following nonspecific pinocytosis into endothelial cells and cells of the reticuloendothelial system. At homeostasis, FcRn recycles IgG to maintain serum IgG levels and extend IgG half-life and also regulates immune cell inflammatory responses to IgG complexes. By targeting the IgG binding site on FcRn, nipocalimab is expected to block the binding and, hence, recycling of IgG, resulting in a decrease in circulating IgG antibody levels, including pathogenic IgG autoantibodies and alloantibodies. Therefore, nipocalimab has potential in the treatment of active IIM by decreasing pathogenic IgG antibody concentrations. The total duration of the study is up to 112 weeks, consisting of 4 study periods: a less than or equal to (<=) 6-week screening period, a 52-week double-blind period, a 48-week long term extension (LTE), and a safety follow-up 8 weeks post last administration of study intervention. Safety assessments include adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), laboratory parameters (hematology and chemistry, including lipid panel), vital signs, and physical examination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 28, 2027
• Est. primary completion date: March 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Disease classification criteria: Participant meets the diagnostic criteria of probable or definite idiopathic inflammatory myopathies (IIM) based on 2017 The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult IIM at least 6 weeks prior to first administration of the study intervention
• If a participant is on regular or as needed treatment with low potency topical glucocorticoids (GC) that are allowed in the study or topical tacrolimus (TAC) to treat skin lesions, the dose and frequency should be stable for greater than or equal to (>=) 4 weeks prior to first administration of the study intervention as well as maintained at the same dose until Week 52 of the study
• Antibody positivity criteria: Any 1 of the myositis-specific antibodies (MSAs) positive: dermatomyositis (DM): anti-Mi-2 (Mi-2/nucleosome remodeling and deacetylase [NuRD] complex), anti-transcription intermediary factor 1-Gamma (TIF1-Gamma), anti- nuclear matrix protein 2 (NXP-2), anti-small ubiquitin-like modifier-1 activating enzyme; anti- antimelanoma differentiation-associated gene 5 (MDA-5) antibodies. Or immune-mediated necrotizing myopathy (IMNM): anti- signal recognition particle (SRP) and anti- 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies. Or anti-synthetase syndrome (ASyS): anti- histidyl- ribonucleic acid [tRNA] synthetase (Jo-1), anti- threonyl-tRNA synthetase (PL7), anti- alanyl-tRNA synthetase (PL12), anti- isoleucyl-tRNA synthetase (OJ), and anti- glycyl-tRNA synthetase (EJ) antibodies. If all MSAs are negative or more than 1 MSA is positive within different subtypes (defined by the central laboratory) at screening, the tests should be repeated during the screening period. If the same results are observed at retesting, the participant should not be enrolled in the study

Exclusion Criteria:

• Has a juvenile myositis diagnosis and now >=18 years old
• Has cancer-associated myositis defined as cancer diagnosis within 3 years of myositis diagnosis except for cervical carcinoma in situ and non-melanoma skin cancer (squamous cell carcinoma, basal cell carcinoma of the skin)
• Has comorbidities (example, asthma, chronic obstructive pulmonary disease [COPD]) which have required 3 or more courses of oral GC within 1 year prior to screening
• Has a history of primary immunodeficiency or secondary immunodeficiency not related to the treatment of the participants IIM
• Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening

Related Conditions & MeSH terms

• Myositis

Intervention

Drug:
• Nipocalimab
Nipocalimab will be administered intravenously in double-blind period and LTE period.

Other:
• Placebo
Nipocalimab matching placebo will be administered intravenously in double-blind period.

Drug:
• Glucocorticoids
Prednisone or equivalent will be administered orally as Glucocorticoid.

Locations

Country	Name	City	State
Canada	Lawson Health Research / London Health Sciences Center Research	London	Ontario
Canada	AMIR Research	Montreal	Quebec
Czechia	Revmatologicky ustav	Praha 2
France	Hospital Pasteur	Nice Cedex 1
France	Hôpital Pitié-Salpétrière	Paris
France	Nouvel Hopital Civil	Strasbourg cedex
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Klinikum der Universitaet Muenchen	München
Germany	Immanuel Klinik Rüdersdorf	Rüdersdorf Bei Berlin
Hungary	Orszagos Mozgasszervi Intezet ORFI Campus	Budapest
Hungary	Debreceni Egyetem	Debrecen
Italy	A.O. Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	IRCSS Ospedale San Raffaele Turro	Milano
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Fondazione Policlinico Universitario A Gemelli IRCCS	Roma
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	St Marianna University Hospital	Kanagawa
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachi Nagano
Japan	Chiba-Nishi General Hospital	Matsudo-shi
Japan	Shinshu University Hospital	Matsumoto
Japan	Tohoku University Hospital	Sendai-Shi
Japan	Nippon Medical School Hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Ciudad de Mexico
Mexico	Centro de Estudios de Investigacion Basica y Clinica, S.C.	Guadalajara
Mexico	Centro Integral en Reumatologia S A de C V	Guadalajara
Mexico	CLIDITER S A de C V	México
Poland	Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher	Warszawa
Spain	Hosp. Univ. de Bellvitge	Barcelona
Spain	Hosp. Univ. de La Paz	Madrid
Spain	Hosp. Univ. Marques de Valdecilla	Santander
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	University College London Hospitals NHSFT	London
United Kingdom	Salford Royal Hospital	Salford
United States	Augusta University	Augusta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Attune Health Autoimmune and Inflamation Care and Research	Beverly Hills	California
United States	FM Clinical Research, LLC South Florida Neurology Associates, P. A.	Boca Raton	Florida
United States	The Brigham and Women's Hospital, Inc.	Boston	Massachusetts
United States	Wexner Medical Center at the Ohio State University	Columbus	Ohio
United States	Nervie and Muscle Center of Texas	Houston	Texas
United States	University of Texas at Houston Medical School	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California Irvine Medical Center	Orange	California
United States	ACME Research Arthritis and Osteoporosis Center	Orangeburg	South Carolina
United States	University of Pennsylvania - Perelman School of Medicine	Philadelphia	Pennsylvania
United States	Arizona Arthritis and Rheumatology Research PLLC	Phoenix	Arizona
United States	Integral Rheumatology And Immunology Specialists	Plantation	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Clinical Research Institute of Michigan, LLC	Saint Clair Shores	Michigan
United States	HonorHealth Neurology	Scottsdale	Arizona
United States	University of South Florida	Tampa	Florida
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52	Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS at Week 52 and on <=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with idiopathic inflammatory myopathies (IIM). Minimal improvement is defined as IMACS TIS greater than or equal to (>=) 20 in participants with IIM. The criteria use the 6 IMACS core set measures: physicians' global activity, patient global activity (PtGA), manual muscle testing (MMT)-8, muscle enzymes, myositis disease activity assessment tool (MDAAT), and health assessment questionnaire-disability index (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Week 52
Secondary	Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Week 24
Secondary	IMACS TIS	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Week 52
Secondary	Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Moderate improvement is defined as IMACS TIS >=40 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Week 24
Secondary	Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52	Change from baseline in MMT-8 score at Week 52 will be reported. Manual muscle testing is a partially validated tool to assess muscle strength. It evaluates 8 muscle groups containing 1 axial, 5 proximal, and 2 distal muscle groups. MMT-8 score ranges from 0-150. Higher score indicates greater muscle strength, that is, less impairment of muscle.	Baseline and Week 52
Secondary	IMACS TIS	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Week 24
Secondary	Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Moderate improvement is defined as IMACS TIS >=40 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Week 52
Secondary	Percentage of Participants who Achieve at Least Major Improvement (>=60) in IMACS TIS	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Major improvement is defined as IMACS TIS >=60 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	At Weeks 24 and 52
Secondary	Change From Baseline in MMT-8 at Week 24	Change from baseline in MMT-8 score at Week 24 will be reported. Manual Muscle Testing is a partially validated tool to assess muscle strength. It evaluates 8 muscle groups containing 1 axial, 5 proximal, and 2 distal muscle groups. MMT-8 score ranges from 0-150. Higher score indicates greater muscle strength, that is, less impairment of muscle.	Baseline and Week 24
Secondary	Change From Baseline in Physician Global Assessment (PhGA) at Weeks 24 and Week 52	Change from baseline in PhGA at Weeks 24 and 52 will be reported. Physician Global Activity is a partially validated tool to measure the global evaluation by the physician of the participant's overall disease activity at the time of assessment using a 10 centimeter (cm) visual analogue scale (VAS), where 0 cm= no evidence of disease activity and 10 cm= extremely active or severe disease activity.	Baseline, Weeks 24 and 52
Secondary	Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52	Change from baseline in MDAAT score at Weeks 24 and 52 will be reported. This is a validated tool which measures the degree of disease activity of extramuscular organ systems and muscle. MDAAT is scored on a 10 centimeter (cm) scale ranging from 0-10 cm where, 0 cm = absent and 10 cm = maximum disease activity. Higher score indicates more disease activity.	Baseline, Weeks 24 and 52
Secondary	Change From Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52	Change from baseline in serum muscle enzymes levels (creatine kinase [CK], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactate dehydrogenase [LDH], and aldolase) at Weeks 24 and 52 will be reported.	Baseline, Weeks 24 and 52
Secondary	Percentage of Participants who Achieve Oral Glucocorticoids (GC) Reduction to 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent), Among Participants on Oral GC Greater Than (>) 5 mg/day at Baseline	Percentage of participants who achieve oral GC reduction to 5 mg/day of oral prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >5 mg/day at baseline will be reported.	From Week 44 through Week 52
Secondary	Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS From Week 44 Through Week 52 and on Less Than or Equal to (<=) 5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52	Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and on <=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	From Week 44 through Week 52
Secondary	Percentage of Participants on <=5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52	Percentage of participants on <=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported.	From Week 44 through Week 52
Secondary	Percentage of Participants who Achieve At Least Minimal Improvement (>=20) in IMACS TIS and Achieve Oral GC Reduction to 5 mg/day at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >5 mg/day at Baseline	Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and achieve oral GC reduction to 5 mg/day of prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >5 mg/day at baseline will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	From Week 44 through Week 52
Secondary	Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS From Week 44 Through Week 52 and on <=7.5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52	Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and on <=7.5 mg/day of Oral Prednisone (or Equivalent) from Week 44 through Week 52 will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	From Week 44 through Week 52
Secondary	Percentage of Participants who Achieve Oral GC Reduction to <=7.5 mg/day of Oral Prednisone (or Equivalent) at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >7.5 mg/day at Baseline	Percentage of participants who achieve oral GC reduction to <=7.5 mg/day of oral prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >7.5 mg/day at baseline will be reported.	At Week 44 through Week 52
Secondary	Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS and Achieve Oral GC Reduction to <=7.5 mg/day at Week 44 and Maintain That Reduction Through Week 52, Among Participants on Oral GC >7.5 mg/day at Baseline	Percentage of participants who achieve at least minimal improvement (>=20) in IMACS TIS from Week 44 through Week 52 and achieve oral GC reduction to <=7.5 mg/day of oral prednisone (or equivalent) at Week 44 and maintain that reduction through Week 52, among participants on oral GC >7.5 mg/day at Baseline will be reported. IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. Minimal improvement is defined as IMACS TIS >=20 in participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	From Week 44 through Week 52
Secondary	IMACS TIS Over Time	IMACS TIS is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with IIM. The criteria use the 6 IMACS core set measures: PhGA, PtGA, MMT-8, muscle enzymes, MDAAT, and HAQ-DI. The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.	Up to 106 weeks
Secondary	Change From Baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Scale Score at Weeks 24 and 52	The CDASI scale is a validated dermatomyositis (DM) specific instrument that systematically quantifies activity and damage in the skin of participant with DM. Disease involvement in 15 different anatomical locations is rated using three activity scales (erythema, scale, erosion/ulceration) and two damage measures (poikiloderma, calcinosis) measures. Gottron's papules/sign on the hands are also evaluated in terms of activity (erythema/ulceration) and damage (dyspigmentation or scarring). Disease activity scores range from 0 to 100. Higher scores indicate greater disease activity.	Baseline, Weeks 24 and 52
Secondary	Change in CDASI Scale Score Over Time	The CDASI scale is a validated DM specific instrument that systematically quantifies activity and damage in the skin of participant with DM. Disease involvement in 15 different anatomical locations is rated using three activity scales (erythema, scale, erosion/ulceration) and two damage measures (poikiloderma, calcinosis) measures. Gottron's papules/sign on the hands are also evaluated in terms of activity (erythema/ulceration) and damage (dyspigmentation or scarring). Disease activity scores range from 0 to 100. Higher scores indicate greater disease activity.	Up to 106 Weeks
Secondary	Percentage of Participants With Treatment-Emergent Adverse Events (AEs)	Any AE occurring at or after the initial administration of study intervention through the safety follow-up visit will be considered as treatment-emergent. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention.	Up to 106 weeks
Secondary	Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)	Any AE occurring at or after the initial administration of study intervention through the safety follow-up visit will be considered as treatment-emergent. An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.	Up to 106 weeks
Secondary	Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)- Physical Function (PF)-20	PROMIS-PF-20 is a participant self-administered 20-item questionnaire assessing the physical function domain. It includes 14 items regarding patients' ability to conduct specific functional activities and 6 items regarding the extent to which their health limits their ability to perform a range of physical activities currently. The 5-point response options for the former items range from 1 "Unable to do" to 5 "Without any difficulty" and the latter items range from 1 "Cannot do" to 5 "Not at all" with higher scores indicating better functioning. The overall score ranges from 0 to 100, where higher score indicates better physical function.	Baseline and Week 52
Secondary	Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI)	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of functional disability a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and common activities of daily living). Responses in each functional area are scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning.	Baseline, Weeks 24 and 52
Secondary	Serum Nipocalimab Concentration Over Time	Serum nipocalimab concentration over time will be reported. Serum nipocalimab concentration will be derived using population pharmacokinetic (PK) modeling.	Baseline Up to Week 98
Secondary	Number of Participants With Anti-drug Antibody (ADA) Measured Using a Validated, Specific, and Sensitive Immunoassay Method	Number of participants with ADA to Nipocalimab measured using a validated, specific, and sensitive immunoassay method will be reported.	Baseline Up to Week 106
Secondary	Number of Participants With Neutralizing Antibodies (Nabs) to Nipocalimab Measured Using a Validated, Specific, and Sensitive Immunoassay Method	Number of participants with Nabs to Nipocalimab measured using a validated, specific, and sensitive immunoassay method will be reported.	Baseline Up to Week 106