MyositisPhase 2SPIREANCT05379634
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
A Phase 2 study testing Nipocalimab and Glucocorticoids in people with Myositis, run by Janssen Research & Development, LLC at 57 sites in 13 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myositis
- What is being tested?
- Nipocalimab and Glucocorticoids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 57 sitesin 13 countries
- Study dates
- 5 Jul 2022to 17 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
United States19 sites
Augusta University
Augusta, Georgia, 30912
Johns Hopkins University
Baltimore, Maryland, 21224
Attune Health Autoimmune and Inflamation Care and Research
Beverly Hills, California, 90211
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida, 33487
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, 02115
Wexner Medical Center at the Ohio State University
Columbus, Ohio, 43203
Nervie and Muscle Center of Texas
Houston, Texas, 77030
University of Texas at Houston Medical School
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California Irvine Medical Center
Orange, California, 92868
ACME Research Arthritis and Osteoporosis Center
Orangeburg, South Carolina, 29118
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Arizona Arthritis and Rheumatology Research PLLC
Phoenix, Arizona, 85032
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324
Oregon Health and Science University
Portland, Oregon, 97239
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081
HonorHealth Neurology
Scottsdale, Arizona, 85251
University of South Florida
Tampa, Florida, 33612
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Japan9 sites
National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563
Fukushima Medical University Hospital
Fukushima, 960 1295
St Marianna University Hospital
Kanagawa, 216 8511
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586 8521
Tokushukai Chiba-Nishi General Hospital
Matsudo-shi, 270-2251
Shinshu University Hospital
Matsumoto, 390-8621
Tohoku University Hospital
Sendai, 980 8574
St. Luke's International Hospital
Tokyo, 104 8560
Nippon Medical School Hospital
Tokyo, 113 8603
Italy4 sites
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60126
IRCSS Ospedale San Raffaele Turro
Milan, 20127
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
Mexico4 sites
Centro Integral en Reumatologia S A de C V
Guadalajara, 44160
Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, 44690
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
México, 06700
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
France3 sites
Hospital Pasteur
Nice, 06000
Hopital Pitie Salpetriere
Paris, 75013
Nouvel Hopital Civil
Strasbourg, 67091
Germany3 sites
Charite Universitaetsmedizin Berlin
Berlin, 10117
Klinikum der Universitaet Muenchen
München, 80336
Immanuel Klinik Rudersdorf
Rüdersdorf Bei Berlin, 15562
Spain3 sites
Hosp. Univ. de Bellvitge
Barcelona, 08907
Hosp. Univ. de La Paz
Madrid, 28046
Hosp. Univ. Marques de Valdecilla
Santander, 39008
United Kingdom3 sites
Western General Hospital
Edinburgh, EH4 2XU
University College London Hospitals NHSFT
London, WC1N 3BG
Salford Royal Hospital
Salford, M6 8HD
Canada2 sites
Lawson Health Research / London Health Sciences Center Research
London, Ontario, N6C 2R5
AMIR Research
Montreal, Quebec, H4A 3T2
Hungary2 sites
Orszagos Mozgasszervi Intezet ORFI Campus
Budapest, 1023
Debreceni Egyetem
Debrecen, 4032
Poland2 sites
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85 168
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, 02 637
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Ajou University Hospital
Suwon, 16499
About this study
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
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
- Conditions
- Myositis
- Being tested
- Nipocalimab, Placebo, Glucocorticoids
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NipocalimabDrug
Also called JNJ-80202135, JNJ-86507083
Nipocalimab will be administered intravenously in double-blind period and LTE period.
PlaceboOther
Nipocalimab matching placebo will be administered intravenously in double-blind period.
GlucocorticoidsDrug
Prednisone or equivalent will be administered orally as Glucocorticoid.
| Study group | Role | What they receive |
|---|---|---|
| Nipocalimab | Experimental | 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. Receives: Drug: Nipocalimab; Drug: Glucocorticoids |
| Placebo | Placebo comparator | 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 will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106. Receives: Other: Placebo; Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 52
Secondary outcomes (28)
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.
Measured: At Week 24
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.
Measured: At Week 52
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.
Measured: At Week 24
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.
Measured: Baseline and Week 52
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.
Measured: At Week 24
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.
Measured: At Week 52
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.
Measured: At Weeks 24 and 52
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.
Measured: Baseline and Week 24
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.
Measured: Baseline, Weeks 24 and 52
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.
Measured: Baseline, Weeks 24 and 52
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.
Measured: Baseline, Weeks 24 and 52
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.
Measured: 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 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.
Measured: From Week 44 through Week 52
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.
Measured: From Week 44 through Week 52
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.
Measured: 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
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.
Measured: From 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
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.
Measured: At Week 44 through Week 52
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.
Measured: From Week 44 through Week 52
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.
Measured: Up to 106 weeks
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.
Measured: Baseline, Weeks 24 and 52
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.
Measured: Up to 106 Weeks
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.
Measured: Up to 106 weeks
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.
Measured: Up to 106 weeks
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.
Measured: Baseline and Week 52
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.
Measured: Baseline, Weeks 24 and 52
Serum Nipocalimab Concentration Over Time
Serum nipocalimab concentration over time will be reported. Serum nipocalimab concentration will be derived using population pharmacokinetic (PK) modeling.
Measured: Baseline Up to Week 98
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.
Measured: Baseline Up to Week 106
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.
Measured: Baseline Up to Week 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start5 Jul 2022
- Primary completion4 Sep 2025
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379634
- Sponsor's protocol ID
- CR109210
- Other IDs
- 80202135IIM2001, 2023-505314-20-00, 2023
- Acronym
- SPIREA
- Status last verified
- Nov 2026
- First submitted
- 17 May 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05379634
- Acronym / sponsor ID
- SPIREA / CR109210
- Conditions
- Myositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nipocalimab | Experimental | Drug: Nipocalimab, Drug: GlucocorticoidsParticipants 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. |
| Placebo | Placebo comparator | Other: Placebo, Drug: GlucocorticoidsParticipants 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 will receive Nipocalimab treatment Q2W starting from Week 52 up to Week 98 and will be followed up to Week 106. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NipocalimabAlso: JNJ-80202135, JNJ-86507083Nipocalimab will be administered intravenously in double-blind period and LTE period. | Drug | Nipocalimab |
| PlaceboNipocalimab matching placebo will be administered intravenously in double-blind period. | Other | Placebo |
| GlucocorticoidsPrednisone or equivalent will be administered orally as Glucocorticoid. | Drug | Nipocalimab, Placebo |
Primary outcome
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.
28 secondary outcomes
Percentage of Participants who Achieve at Least Minimal Improvement (>=20) in IMACS TIS
Time frame: At Week 24
IMACS TIS
Time frame: At Week 52
Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS
Time frame: At Week 24
Change From Baseline in Manual Muscle Testing (MMT)-8 at Week 52
Time frame: Baseline and Week 52
IMACS TIS
Time frame: At Week 24
Percentage of Participants who Achieve at Least Moderate Improvement (>=40) in IMACS TIS
Time frame: At Week 52
Percentage of Participants who Achieve at Least Major Improvement (>=60) in IMACS TIS
Time frame: At Weeks 24 and 52
Change From Baseline in MMT-8 at Week 24
Time frame: Baseline and Week 24
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 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 Serum Muscle Enzymes Levels at Weeks 24 and 52
Time frame: Baseline, Weeks 24 and 52
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 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 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 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 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 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 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
IMACS TIS Over Time
Time frame: Up to 106 weeks
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
Change in CDASI Scale Score Over Time
Time frame: Up to 106 Weeks
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Time frame: Up to 106 weeks
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: Up to 106 weeks
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)- Physical Function (PF)-20
Time frame: Baseline and Week 52
Change From Baseline in Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI)
Time frame: Baseline, Weeks 24 and 52
Serum Nipocalimab Concentration Over Time
Time frame: Baseline Up to Week 98
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 Neutralizing Antibodies (Nabs) to Nipocalimab Measured Using a Validated, Specific, and Sensitive Immunoassay Method
Time frame: Baseline Up to Week 106
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nipocalimab and Glucocorticoids in people with Myositis, run by Janssen Research & Development, LLC at 57 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Japan, Italy, Mexico, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.