A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies (SPIREA)

• ClinicalTrials.gov Identifier: NCT05379634
• Recruitment Status: Recruiting
• First Posted: May 18, 2022
• Last Update Posted: April 24, 2024
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Myositis	Drug: Nipocalimab; Other: Placebo; Drug: Glucocorticoids	Phase 2

Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 5, 2022
• Estimated Primary Completion Date: March 2, 2026
• Estimated Study Completion Date: October 28, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nipocalimab; Participants will receive Nipocalimab at Week 0 (Baseline) and then every 2 weeks (Q2W) up to Week 50 during double-blind period. Participants on glucocorticoids (GC) at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter long-term extension (LTE) period and continue receiving Nipocalimab starting from Week 52 up to Week 98 and will be followed up to Week 106.	Drug: Nipocalimab; Nipocalimab will be administered intravenously in double-blind period and LTE period.; Other Name: JNJ-80202135; Drug: Glucocorticoids; Prednisone or equivalent will be administered orally as Glucocorticoid.
Placebo Comparator: Placebo; Participants will receive Nipocalimab matching placebo at Week 0 (Baseline) and then Q2W up to Week 50 during double-blind period. Participants on GC at baseline will receive a stable dose of oral GC (prednisone or equivalent) from 4 weeks prior to the first administration of study intervention to Week 0. No changes in GC doses are allowed between Week 0 and Week 24. From Week 24 to Week 44, GC doses will be tapered. No changes to GC doses will be allowed from Week 44 to Week 52. Eligible participants will enter LTE period and continue receiving Nipocalimab matching placebo Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106.	Other: Placebo; Nipocalimab matching placebo will be administered intravenously in double-blind period.; Drug: Glucocorticoids; Prednisone or equivalent will be administered orally as Glucocorticoid.

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: At 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.

Secondary Outcome Measures :

1. Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS [ Time Frame: At Week 24 ]
   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.
2. IMACS TIS [ Time Frame: At Week 52 ]
   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.
3. Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS [ Time Frame: At Week 24 ]
   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.
4. Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52 [ Time Frame: Baseline and 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.
5. IMACS TIS [ Time Frame: At Week 24 ]
   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.
6. Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS [ Time Frame: At Week 52 ]
   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.
7. Percentage of Participants who Achieve at Least Major Improvement (>=60) in IMACS TIS [ Time Frame: At Weeks 24 and 52 ]
   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.
8. Change From Baseline in MMT-8 at Week 24 [ Time Frame: Baseline and 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.
9. Change From Baseline in Physician Global Assessment (PhGA) at Weeks 24 and Week 52 [ Time Frame: Baseline, Weeks 24 and 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.
10. Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52 [ Time Frame: Baseline, 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.
11. Change From Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52 [ Time Frame: Baseline, 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.
12. 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 [ Time Frame: From Week 44 through Week 52 ]
    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.
13. 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 [ Time Frame: 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.
14. Percentage of Participants on <=5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 [ Time Frame: 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.
15. 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 [ Time Frame: 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 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.
16. 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 [ Time Frame: 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.
17. 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 [ Time Frame: At Week 44 through Week 52 ]
    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.
18. 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 [ Time Frame: 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 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.
19. IMACS TIS Over Time [ Time Frame: Up to 106 weeks ]
    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.
20. Change From Baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Scale Score at Weeks 24 and 52 [ Time Frame: Baseline, 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.
21. Change in CDASI Scale Score Over Time [ Time Frame: Up to 106 Weeks ]
    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.
22. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Up to 106 weeks ]
    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.
23. Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: Up to 106 weeks ]
    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.
24. Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)- Physical Function (PF)-20 [ Time Frame: Baseline and Week 52 ]
    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.
25. Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI) [ Time Frame: Baseline, Weeks 24 and 52 ]
    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.
26. Serum Nipocalimab Concentration Over Time [ Time Frame: Baseline Up to Week 98 ]
    Serum nipocalimab concentration over time will be reported. Serum nipocalimab concentration will be derived using population pharmacokinetic (PK) modeling.
27. Number of Participants With Anti-drug Antibody (ADA) Measured Using a Validated, Specific, and Sensitive Immunoassay Method [ Time Frame: Baseline Up to Week 106 ]
    Number of participants with ADA to Nipocalimab measured using a validated, specific, and sensitive immunoassay method will be reported.
28. Number of Participants With Neutralizing Antibodies (Nabs) to Nipocalimab Measured Using a Validated, Specific, and Sensitive Immunoassay Method [ Time Frame: Baseline Up to Week 106 ]
    Number of participants with Nabs to Nipocalimab measured using a validated, specific, and sensitive immunoassay method will be reported.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

Locations

United States, Arizona

Arizona Arthritis and Rheumatology Research PLLC; Recruiting

Phoenix, Arizona, United States, 85032

HonorHealth Neurology; Recruiting

Scottsdale, Arizona, United States, 85251

United States, California

Attune Health Autoimmune and Inflamation Care and Research; Recruiting

Beverly Hills, California, United States, 90211

University of California Irvine Medical Center; Recruiting

Orange, California, United States, 92868

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; Recruiting

Torrance, California, United States, 90502

United States, Florida

FM Clinical Research, LLC South Florida Neurology Associates, P. A.; Recruiting

Boca Raton, Florida, United States, 33487

Integral Rheumatology And Immunology Specialists; Recruiting

Plantation, Florida, United States, 33324

University of South Florida; Recruiting

Tampa, Florida, United States, 33612

United States, Georgia

Augusta University; Recruiting

Augusta, Georgia, United States, 30912

United States, Kansas

University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21224

United States, Massachusetts

The Brigham and Women's Hospital, Inc.; Recruiting

Boston, Massachusetts, United States, 02115

United States, Michigan

Clinical Research Institute of Michigan, LLC; Recruiting

Saint Clair Shores, Michigan, United States, 48081

United States, Ohio

Wexner Medical Center at the Ohio State University; Completed

Columbus, Ohio, United States, 43203

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

United States, Pennsylvania

University of Pennsylvania - Perelman School of Medicine; Recruiting

Philadelphia, Pennsylvania, United States, 19104

United States, South Carolina

ACME Research Arthritis and Osteoporosis Center; Completed

Orangeburg, South Carolina, United States, 29118

United States, Texas

Nervie and Muscle Center of Texas; Recruiting

Houston, Texas, United States, 77030

University of Texas at Houston Medical School; Recruiting

Houston, Texas, United States, 77030

Canada, Ontario

Lawson Health Research / London Health Sciences Center Research; Recruiting

London, Ontario, Canada, N6C 2R5

Canada, Quebec

AMIR Research; Recruiting

Montreal, Quebec, Canada, H4A 3T2

Czechia

Revmatologicky ustav; Recruiting

Praha 2, Czechia, 128 50

France

Hospital Pasteur; Recruiting

Nice Cedex 1, France, 06000

Hôpital Pitié-Salpétrière; Recruiting

Paris, France, 75013

Nouvel Hopital Civil; Recruiting

Strasbourg cedex, France, 67091

Germany

Charite Universitatsmedizin Berlin; Completed

Berlin, Germany, 10117

Klinikum der Universitaet Muenchen; Recruiting

München, Germany, 80336

Immanuel Klinik Rüdersdorf; Recruiting

Rüdersdorf Bei Berlin, Germany, 15562

Hungary

Orszagos Mozgasszervi Intezet ORFI Campus; Recruiting

Budapest, Hungary, 1023

Debreceni Egyetem; Recruiting

Debrecen, Hungary, 4032

Italy

A.O. Universitaria Ospedali Riuniti di Ancona; Recruiting

Ancona, Italy, 60126

IRCCS Ospedale San Raffaele HSR; Recruiting

Milano, Italy, 20132

Fondazione IRCCS Policlinico San Matteo; Recruiting

Pavia, Italy, 27100

Fondazione Policlinico Universitario A Gemelli IRCCS; Recruiting

Roma, Italy, 00168

Japan

National Hospital Organization Kyushu Medical Center; Recruiting

Fukuoka, Japan, 810 8563

Fukushima Medical University Hospital; Recruiting

Fukushima, Japan, 960-1295

St Marianna University Hospital; Recruiting

Kanagawa, Japan, 216-8511

National Hospital Organization Osaka Minami Medical Center; Recruiting

Kawachi-Nagano, Japan, 586-8521

Chiba-Nishi General Hospital; Recruiting

Matsudo-shi, Japan, 270-2251

Shinshu University Hospital; Recruiting

Matsumoto, Japan, 390-8621

Tohoku University Hospital; Recruiting

Sendai-Shi, Japan, 980-8574

St. Luke's International Hospital; Recruiting

Tokyo, Japan, 104 8560

Nippon Medical School Hospital; Recruiting

Tokyo, Japan, 113-8603

Korea, Republic of

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Ajou University Hospital; Recruiting

Suwon-si, Korea, Republic of, 16499

Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Recruiting

Ciudad de Mexico, Mexico, 14080

Centro Integral en Reumatologia S A de C V; Recruiting

Guadalajara, Mexico, 44160

Centro de Estudios de Investigacion Basica y Clinica, S.C.; Recruiting

Guadalajara, Mexico, 44690

CLIDITER S A de C V; Recruiting

México, Mexico, 06700

Poland

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy; Recruiting

Bydgoszcz, Poland, 85 168

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher; Recruiting

Warszawa, Poland, 02 637

Spain

Hosp. Univ. de Bellvitge; Recruiting

Barcelona, Spain, 08907

Hosp. Univ. de La Paz; Recruiting

Madrid, Spain, 28046

Hosp. Univ. Marques de Valdecilla; Recruiting

Santander, Spain, 39008

United Kingdom

Western General Hospital; Recruiting

Edinburgh, United Kingdom, EH4 2XU

University College London Hospitals NHSFT; Recruiting

London, United Kingdom, WC1N 3BG

Salford Royal Hospital; Recruiting

Salford, United Kingdom, M6 8HD

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT05379634
• Other Study ID Numbers: CR109210; 2021-005202-98 ( EudraCT Number ); 80202135IIM2001 ( Other Identifier: Janssen Research & Development, LLC ); 2023-505314-20-00 ( Registry Identifier: EUCT number ); 2023-505314-20 ( EudraCT Number )
• First Posted: May 18, 2022
• Last Update Posted: April 24, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs