Clinical trial NCT05379634: A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Myositis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: At Week 52
Secondary outcomes:
measure: Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS
timeFrame: At Week 24
measure: IMACS TIS
timeFrame: At Week 52
measure: Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS
timeFrame: At Week 24
measure: Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52
timeFrame: Baseline and Week 52
measure: IMACS TIS
timeFrame: At Week 24
measure: Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS
timeFrame: At Week 52
measure: Percentage of Participants who Achieve at Least Major Improvement (>=60) in IMACS TIS
timeFrame: At Weeks 24 and 52
measure: Change From Baseline in MMT-8 at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Physician Global Assessment (PhGA) at Weeks 24 and Week 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Extramuscular Global Assessment (Myositis Disease Activity Assessment Tool [MDAAT]) at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Serum Muscle Enzymes Levels at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: 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
timeFrame: From Week 44 through Week 52
measure: 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
timeFrame: From Week 44 through Week 52
measure: Percentage of Participants on <=5 mg/day of Oral Prednisone (or Equivalent) From Week 44 Through Week 52
timeFrame: From Week 44 through Week 52
measure: 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
timeFrame: From Week 44 through Week 52
measure: 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
timeFrame: From Week 44 through Week 52
measure: 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
timeFrame: At Week 44 through Week 52
measure: 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
timeFrame: From Week 44 through Week 52
measure: IMACS TIS Over Time
timeFrame: Up to 106 weeks
measure: Change From Baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Scale Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change in CDASI Scale Score Over Time
timeFrame: Up to 106 Weeks
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: Up to 106 weeks
measure: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: Up to 106 weeks
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)- Physical Function (PF)-20
timeFrame: Baseline and Week 52
measure: Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI)
timeFrame: Baseline, Weeks 24 and 52
measure: Serum Nipocalimab Concentration Over Time
timeFrame: Baseline Up to Week 98
measure: Number of Participants With Anti-drug Antibody (ADA) Measured Using a Validated, Specific, and Sensitive Immunoassay Method
timeFrame: Baseline Up to Week 106
measure: Number of Participants With Neutralizing Antibodies (Nabs) to Nipocalimab Measured Using a Validated, Specific, and Sensitive Immunoassay Method
timeFrame: Baseline Up to Week 106
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Neurology
state: Arizona
city: Beverly Hills
country: United States
facility: Attune Health Autoimmune and Inflamation Care and Research
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Boca Raton
country: United States
facility: FM Clinical Research, LLC South Florida Neurology Associates, P. A.
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: The Brigham and Women's Hospital, Inc.
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Columbus
country: United States
facility: Wexner Medical Center at the Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman School of Medicine
state: Pennsylvania
city: Orangeburg
country: United States
facility: ACME Research Arthritis and Osteoporosis Center
state: South Carolina
city: Houston
country: United States
facility: Nervie and Muscle Center of Texas
state: Texas
city: Houston
country: United States
facility: University of Texas at Houston Medical School
state: Texas
city: London
country: Canada
facility: Lawson Health Research / London Health Sciences Center Research
state: Ontario
city: Montreal
country: Canada
facility: AMIR Research
state: Quebec
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Nice Cedex 1
country: France
facility: Hospital Pasteur
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Strasbourg cedex
country: France
facility: Nouvel Hopital Civil
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: München
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Rüdersdorf Bei Berlin
country: Germany
facility: Immanuel Klinik Rüdersdorf
city: Budapest
country: Hungary
facility: Orszagos Mozgasszervi Intezet ORFI Campus
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Ancona
country: Italy
facility: A.O. Universitaria Ospedali Riuniti di Ancona
city: Milano
country: Italy
facility: IRCSS Ospedale San Raffaele Turro
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli IRCCS
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Kawachi Nagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Matsudo-shi
country: Japan
facility: Tokushukai Chiba-Nishi General Hospital
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Sendai-Shi
country: Japan
facility: Tohoku University Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia S A de C V
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica, S.C.
city: Mexico
country: Mexico
facility: CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
city: Barcelona
country: Spain
facility: Hosp. Univ. de Bellvitge
city: Madrid
country: Spain
facility: Hosp. Univ. de La Paz
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHSFT
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: