Clinical trial • Phase II • Neurology|Rare Disease
NIPOCALIMAB for Idiopathic inflammatory myopathies (IIM)
Phase II trial of NIPOCALIMAB for Idiopathic inflammatory myopathies (IIM).
Overview
- Trial Therapeutic Area
- Neurology|Rare Disease
- Trial Disease
- Idiopathic inflammatory myopathies (IIM)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 12-12-2023
- First CTIS Authorization Date
- 01-02-2024
Trial design
Randomised, saline, 0.9% sodium chloride solution for injection (placebo). dose and schedule not specified in the record.-controlled Phase II trial in Germany, France, Poland and others.
- Randomised
- Yes
- Comparator
- Saline, 0.9% Sodium Chloride Solution for Injection (placebo). Dose and schedule not specified in the record.
- Target Sample Size
- 129
- Trial Duration For Participant
- 364
Eligibility
Recruits 129 Vulnerable population selected. Subject information and informed consent materials include main SIS-ICF, caregiver ICF, pregnant partner ICF and optional genetic research ICFs. Consent is obtained from adult participants; caregiver-specific consent/information forms are available where relevant. Documents available in multiple languages..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent materials include main SIS-ICF, caregiver ICF, pregnant partner ICF and optional genetic research ICFs. Consent is obtained from adult participants; caregiver-specific consent/information forms are available where relevant. Documents available in multiple languages.
Inclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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 immunemediated 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- histidylribonucleic acid [tRNA] synthetase (Jo-1), anti- threonyl-tRNA synthetase (PL7), anti- alanyl-tRNA synthetase (PL12), anti- isoleucyltRNA 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
- {"criterion_text":"- Has a juvenile myositis diagnosis and now ≥18 years old"}
- {"criterion_text":"- Has cancer-associated myositis defined as cancer diagnosis within 3 years of myositis diagnosis except for cervical carcinoma in situ and nonmelanoma skin cancer (squamous cell carcinoma, basal cell carcinoma of the skin)"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Has a history of primary immunodeficiency or secondary immunodeficiency not related to the treatment of the participants IIM."}
- {"criterion_text":"- Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion Percentage of participants who achieve at least minimal improvement (≥ 20-point improvement) in IMACS TIS (International myositis assessment and clinical studies total improvement score) at Week 52 and on ≤5 mg/day of oral prednisone (or equivalent) from week 44 through week 52.","definition_or_measurement_approach":"Measured as the percentage of participants achieving ≥20-point improvement in IMACS TIS at Week 52 and receiving ≤5 mg/day oral prednisone (or equivalent) during Weeks 44–52."}
Recruitment
- Digital Remote Recruitment
- True, patient email recruitment materials and electronic communications are used (country-specific patient email templates available).
- Planned Sample Size
- 129
- Recruitment Window Months
- 49
- Consent Approach
- Informed consent obtained from adult participants using subject information sheets and ICFs. Separate caregiver ICFs and pregnant partner ICFs are available. Optional genetic research consent forms provided. Consent documents available in multiple languages (including English, Spanish, Italian, German, French, Czech, Hungarian as per documentation).
Methods
- Recruitment brochures (patient brochures) — channel: printed/handout materials; target: patients with idiopathic inflammatory myopathies; country-specific versions available
- Physician-to-patient email/letter — channel: communications via treating physicians to patients; country-specific templates available
- Posters — channel: clinic/hospital posters; patient-facing
- Patient email — direct electronic contact with potential participants
- Patient letter — mailed or handed letters to patients
- Study visit guide — provided to participants to describe visits and procedures
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 62
Germany
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 01-02-2024
- Processing Time Days
- 23
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Centrum 12 für Innere Medizin und Dermatologie Klinik mS Rheumatologie und Klinische Immunologie
- Contact Person Name
- Udo Schneider
- Contact Person Email
- udo.schneider@charite.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Universitaets-Hautklinik, Psoriasiszentrum
- Contact Person Name
- Matthias Hahn
- Contact Person Email
- matthias.hahn@med.uni-tuebingen.de
- Site Name
- Immanuel Klinik Ruedersdorf
- Department Name
- Universitätsklinikum der Medizinischen Hochschule Brandenburg Theodor Fontane
- Contact Person Name
- Jens Schmidt
- Contact Person Email
- Jens.Schmidt@mhb-fontane.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Neurologische Klinik und Poliklinik
- Contact Person Name
- Benedikt Schoser
- Contact Person Email
- Benedikt.Schoser@med.uni-muenchen.de
France
- Earliest CTIS Part Ii Submission Date
- 09-02-2024
- Latest Decision Or Authorization Date
- 16-02-2024
- Processing Time Days
- 7
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Département de Physiologie et d’explorations fonctionnelles
- Contact Person Name
- Alain MEYER
- Contact Person Email
- alain.meyer1@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine Interne et Immunologie Clinique
- Contact Person Name
- Olivier Benveniste
- Contact Person Email
- olivier.benveniste@psl.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Département de Neurologie/Centre de Référence des Maladies Neuromusculaires et SLA
- Contact Person Name
- Sabrina Sacconi
- Contact Person Email
- SACCONI.S@chu-nice.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 09-02-2024
- Processing Time Days
- 31
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Centrum Wsparcia Badań Klinicznych
- Contact Person Name
- Marzena Olesińska
- Contact Person Email
- marzena.olesinska@spartanska.pl
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
- Contact Person Name
- Tomasz Jankowski
- Contact Person Email
- tojankowski@gazeta.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 05-02-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- University Of Debrecen
- Department Name
- Klinikai Kozpont, Belgyogyaszati Klinika C epulet
- Contact Person Name
- Zoltan Griger
- Contact Person Email
- griger.zoltan@med.unideb.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 06-02-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Rheumatology Service
- Contact Person Name
- Ricardo Blanco Alonso
- Contact Person Email
- ricardo.blanco@scsalud.es
Italy
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 05-02-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 17
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neuromuscular Repair Unit
- Contact Person Name
- Stefano Carlo Previtali
- Contact Person Email
- previtali.stefano@hsr.it
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-01-2024
- Latest Decision Or Authorization Date
- 06-02-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Revmatologicky Ustav
- Department Name
- Oddeleni klinickych hodnoceni
- Contact Person Name
- Jiří Vencovský
- Contact Person Email
- vencovsky@revma.cz
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Adjudication Committee; Vendor Management-(SCOUT/TransPerfect)
- Name
- Imperial Clinical Research Services International Limited
- Responsibilities
- Site materials printing
- Name
- Scout Clinical
- Responsibilities
- Patient transportation
Third parties
- {"country":"France","full_name":"Quipment","duties_or_roles":"Ancillary supply management","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Pulmonary Function Tests","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Adjudication Committee; Vendor Management-(SCOUT/TransPerfect)","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Imperial Clinical Research Services International Limited","duties_or_roles":"Site materials printing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"Investigators meeting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"HRCT Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"Ancillary supply management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient transportation","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- JNJ-80202135 (SOLUTION FOR INJECTION)
- Active Substance
- NIPOCALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Investigational Product Name
- JNJ-80202135 (SOLUTION FOR INFUSION)
- Active Substance
- NIPOCALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Investigational Product Name
- Saline, 0.9% Sodium Chloride Solution for Injection
- Modality
- Other
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