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    Summary
    EudraCT Number:2021-005202-98
    Sponsor's Protocol Code Number:80202135IIM2001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-005202-98
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of Nipocalimab for Adults with Active Inflammatory Myopathies
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety Study of Nipocalimab for Adults with IIM
    A.4.1Sponsor's protocol code number80202135IIM2001
    A.5.4Other Identifiers
    Name:INDNumber:153835
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 2166
    B.5.5Fax number+31(0)71524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNipocalimab
    D.3.2Product code M281/JNJ-80202135
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnipocalimab
    D.3.9.1CAS number 2211985-36-1
    D.3.9.2Current sponsor codeJNJ-80202135
    D.3.9.3Other descriptive nameM281
    D.3.9.4EV Substance CodeSUB195356
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Idiopathic Inflammatory Myopathies (IIM)
    E.1.1.1Medical condition in easily understood language
    Active Idiopathic Inflammatory Myopathies
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028640
    E.1.2Term Myopathies
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of nipocalimab vs placebo in participants with active IIM.
    E.2.2Secondary objectives of the trial
    - To further evaluate the efficacy of nipocalimab vs placebo across a range of outcome measures in participants with active IIM.
    - To evaluate the efficacy of nipocalimab vs placebo in oral GC reduction in participants with active IIM.
    - To evaluate the efficacy of nipocalimab vs placebo in disease activity improvement over time in participants with active IIM.
    - To evaluate the safety and tolerability of nipocalimab vs placebo in participants with active IIM
    - To evaluate the impact of nipocalimab on PROs in participants with active IIM.
    - To evaluate the PK and immunogenicity of nipocalimab in participants with active IIM.
    - DM participants only: To evaluate the efficacy of nipocalimab vs placebo in cutaneous disease activity improvement in participants with active IIM.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Thigh Muscle MRI Sub-study (Optional)
    - Muscle Biopsy Sub-study (Optional)
    E.3Principal 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-serious adverse event (SAE); 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 (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
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants who achieve at least minimal improvement (≥20) in IMACS TIS (International myositis assessment and clinical studies total improvement score) and on ≤5 mg/day of oral prednisone (or equivalent) from week 44 through week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 52
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    - Percentage of Participants who Achieve at Least Minimal Improvement (≥20) in IMACS TIS at Week 24.
    - IMACS TIS at Week 52
    - Percentage of Participants who Achieve at Least Moderate Improvement (≥40) in IMACS TIS at Week 24.
    - Change From Baseline in Manual Muscle Testing (MMT)-8 at 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.
    - 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.
    - Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function (PF-20) at Week 52

    Other Secondary Endpoints:
    - IMACS TIS at Week 24
    - Percentage of Participants who Achieve at Least Moderate Improvement (≥40) in IMACS TIS at Week 52.
    - Percentage of Participants who Achieve at Least Major Improvement (≥60) in IMACS TIS at Weeks 24 and 52.
    - Change from Baseline in MMT-8 at Week 24
    - Change from Baseline in Physician Global Assessment (PhGA) at 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 Serum Muscle Enzymes Levels at Weeks 24 and 52
    - Percentage of Participants on ≤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 and Achieve oral GC Reduction to 5 mg/day at Week 44 and Maintain that Reduction Through Week 52, Among Participants on Oral GC >5mg/day at Baseline
    - 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 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 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
    - IMAC TIS Over time (Up to 106 Weeks)
    - Change in Baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Scale Score at Weeks 24 and 52
    - Change in CDASI Scale Score Over Time (Up to 106 Weeks)
    - Percentage of Participants with Treatment-Emergent Adverse Events (AEs) (up to 106 Weeks)
    - Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs) (up to 106 Weeks)
    - Change From Baseline In Functional Disability Using the Health Assessment Questionnaire-disability Index (HAQ-DI) at Weeks 24 and 52
    - Serum Nipocalimab Concentration Over Time (Baseline Up To Week 98)
    - Number of Participants With Anti-Drug Antibody (ADA) (Baseline Up To Week 106)
    - Number of Participants With Neutralizing Antibodies (Nabs) to Nipocalimab (Baseline Up To Week 106)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Japan
    Korea, Republic of
    Mexico
    United States
    France
    Poland
    Netherlands
    Spain
    Czechia
    Germany
    Italy
    Hungary
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of their participation in the first 52 weeks of the study, participants who have met the eligibility criteria will be offered the opportunity to enter the LTE. After the LTE, the participant will have the option to continue nipocalimab through other access programs if available per local regulations.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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