Clinical trial • Phase II • Immunology|Musculoskeletal
IMEROPRUBART for Rheumatoid arthritis (ACPA-positive)
Phase II trial of IMEROPRUBART for Rheumatoid arthritis (ACPA-positive).
Overview
- Trial Therapeutic Area
- Immunology|Musculoskeletal
- Trial Disease
- Rheumatoid arthritis (ACPA-positive)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-02-2025
- First CTIS Authorization Date
- 30-05-2025
Trial design
Randomised, placebo ("placebo is identical to imp but with no active substance")-controlled Phase II trial across 37 sites in Czechia, Spain, Hungary and others.
- Randomised
- Yes
- Comparator
- Placebo ("Placebo is identical to IMP but with no active substance")
- Target Sample Size
- 123
- Trial Duration For Participant
- 196
Eligibility
Recruits 123 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is from adult participants. Supporting person / caregiver information and caregiver ICF documents are provided (L1_SIS and ICF_Caregiver_*, L1_SIS-ICF_Supporting Person_DE etc.) and language-specific ICFs are available..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is from adult participants. Supporting person / caregiver information and caregiver ICF documents are provided (L1_SIS and ICF_Caregiver_*, L1_SIS-ICF_Supporting Person_DE etc.) and language-specific ICFs are available.
Inclusion criteria
- {"criterion_text":"- Have a diagnosis of ‘definite RA’ according to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria\n- Greater than or equal to 6/68 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.\n- C-reactive protein ≥ upper limit of normal (ULN) at screening visit\n- Elevated immunoglobulin G (IgG) + ACPA as the Screening Visit.\n- Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs"}
Exclusion criteria
- {"criterion_text":"- Have received rituximab and experienced insufficient efficacy or loss of efficacy.\n- History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA\n- Active malignancy or history of malignancy within 5 years prior to screening visit\n- Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.\n- Used any nonimmunosuppresive Fc-based therapeutic protein (e.g., mAb or Fc-fusion protein) within 4 weeks prior to or at screening visit.\n- Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or have a documented history of non-response to prior anti-FcRn treatment"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants who achieve ACR20 response at Week 28.","definition_or_measurement_approach":"ACR20 response as assessed at Week 28 (American College of Rheumatology 20% response)"}
Secondary endpoints
- {"endpoint_text":"- Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28.","definition_or_measurement_approach":"Change in CDAI score between Week 16 and Week 28"}
- {"endpoint_text":"- Change in Simplified Disease Activity Index (SDAI) score from week 16 to Week 28","definition_or_measurement_approach":"Change in SDAI score between Week 16 and Week 28"}
Recruitment
- Registry Or Advocacy Recruitment
- True, Patient Advocacy Group One Sheet documents are provided (no specific advocacy organisation named)
- Planned Sample Size
- 123
- Recruitment Window Months
- 27
- Consent Approach
- Informed consent provided by adult participants (no paediatric participants). Subject information sheets and ICFs (L1_SIS and ICF_Main and language-specific variants) are provided in multiple languages (EN, DE, ES, HU, PL, RO, BG, CZ). Optional modules (e.g., genetic testing, pregnancy, home care, caregiver) and supporting-person/caregiver information are available as separate ICF/documents.
Methods
- Dear Doctor Letter (physician outreach) — country-specific K2_Recruitment material_Dear Doctor Letter_[country]_redacted (available for CZ, ES, HU, PL, RO, BG, DE)
- Dear Patient Letter / Patient Brochure (patient-targeted printed materials) — K2_Recruitment material_Dear Patient Letter_* and Patient Brochure_* (country-specific/local-language)
- Posters (clinic / public posters) — K2_Recruitment material_Poster_[country]
- Patient Visit Guide (information for participants attending visits) — K2_Recruitment material_Patient Visit Guide_[country]
- Patient Advocacy Group outreach (one-sheet) — K2_Recruitment material_Patient Advocacy Group One Sheet_[country] (used for advocacy engagement)
- Recruitment and Informed Consent Procedure documents (K1) describing local recruitment arrangements per country (e.g., K1_Recruitment and Informed consent procedure_[country])
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 168
Czechia
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 01-10-2025
- Processing Time Days
- 139
- Number Of Sites
- 5
- Number Of Participants
- 24
Sites
- Site Name
- Vesalion s.r.o.
- Department Name
- Not applicable
- Principal Investigator Name
- Libor Novosad
- Principal Investigator Email
- libor.novosad@email.cz
- Contact Person Name
- Libor Novosad
- Contact Person Email
- libor.novosad@email.cz
- Site Name
- Medical Plus s.r.o.
- Department Name
- Not applicable
- Principal Investigator Name
- Eva Dokoupilova
- Principal Investigator Email
- pavli.misova@seznam.cz
- Contact Person Name
- Eva Dokoupilova
- Contact Person Email
- pavli.misova@seznam.cz
- Site Name
- Revmatologicky Ustav
- Department Name
- Oddeleni experimentalni revmatologie
- Principal Investigator Name
- Ladislav Senolt
- Principal Investigator Email
- senolt@revma.cz
- Contact Person Name
- Ladislav Senolt
- Contact Person Email
- senolt@revma.cz
- Site Name
- PV Medical Services s.r.o.
- Department Name
- Revmatologicka ambulance
- Principal Investigator Name
- Petr Vitek
- Principal Investigator Email
- pv.medical@seznam.cz
- Contact Person Name
- Petr Vitek
- Contact Person Email
- pv.medical@seznam.cz
- Site Name
- Revmatologie s.r.o.
- Department Name
- Rheumatology Department
- Principal Investigator Name
- Nemec Petr
- Principal Investigator Email
- petr.nemec@fnusa.cz
- Contact Person Name
- Nemec Petr
- Contact Person Email
- petr.nemec@fnusa.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 07-04-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 175
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Rheumatology
- Principal Investigator Name
- Jose Javier Pérez Venejas
- Principal Investigator Email
- perez.venegas@gmail.com
- Contact Person Name
- Jose Javier Pérez Venejas
- Contact Person Email
- perez.venegas@gmail.com
- Site Name
- Hospital Universitario Basurto
- Department Name
- Rheumatology
- Principal Investigator Name
- María Luz García Vivar
- Principal Investigator Email
- marialuz.garciavivar@osakidetza.net
- Contact Person Name
- María Luz García Vivar
- Contact Person Email
- marialuz.garciavivar@osakidetza.net
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Rheumatology
- Principal Investigator Name
- Sara Manrique Arija
- Principal Investigator Email
- sarama_82@hotmail.com
- Contact Person Name
- Sara Manrique Arija
- Contact Person Email
- sarama_82@hotmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Servicio de Reumatologia
- Principal Investigator Name
- Antonio Gomez Centeno
- Principal Investigator Email
- agomez@tauli.cat
- Contact Person Name
- Antonio Gomez Centeno
- Contact Person Email
- agomez@tauli.cat
Hungary
- Earliest CTIS Part Ii Submission Date
- 22-05-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 130
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Budai Irgalmasrendi Korhaz Nonprofit Kft.
- Principal Investigator Name
- Bernadette Rojkovics
- Principal Investigator Email
- bernadette.rojkovich@reumatologia.hu
- Contact Person Name
- Bernadette Rojkovics
- Contact Person Email
- bernadette.rojkovich@reumatologia.hu
- Site Name
- Vasarhelyi Sarkanyfu Kft.
- Principal Investigator Name
- Eva Balazs
- Principal Investigator Email
- jimbies@gmail.hu
- Contact Person Name
- Eva Balazs
- Contact Person Email
- jimbies@gmail.hu
- Site Name
- Revita Kft.
- Principal Investigator Name
- Megyaszai Marta
- Principal Investigator Email
- m.megyaszai@gmail.com
- Contact Person Name
- Megyaszai Marta
- Contact Person Email
- m.megyaszai@gmail.com
- Site Name
- Vital-Medicina Kft.
- Department Name
- Rheumatology and Physical Rehabilitation
- Principal Investigator Name
- Edit Dresher
- Principal Investigator Email
- drescher.edit@vmkorhaz.hu
- Contact Person Name
- Edit Dresher
- Contact Person Email
- drescher.edit@vmkorhaz.hu
- Site Name
- Je-Med Bt.
- Department Name
- Rheumatology
- Principal Investigator Name
- Edit Sebok
- Principal Investigator Email
- sebokditke@gmail.com
- Contact Person Name
- Edit Sebok
- Contact Person Email
- sebokditke@gmail.com
- Site Name
- Complex Rendelo Med Zrt.
- Department Name
- Rheumatology
- Principal Investigator Name
- Kata Kerekes
- Principal Investigator Email
- drkerekeskata@yahoo.com
- Contact Person Name
- Kata Kerekes
- Contact Person Email
- drkerekeskata@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 21-05-2025
- Latest Decision Or Authorization Date
- 27-09-2025
- Processing Time Days
- 129
- Number Of Sites
- 10
- Number Of Participants
- 50
Sites
- Site Name
- NZOZ Lecznica Mak Med s.c.
- Department Name
- Rheumatology
- Principal Investigator Name
- Marek Krogulec
- Principal Investigator Email
- marekkrogulec@wp.pl
- Contact Person Name
- Marek Krogulec
- Contact Person Email
- marekkrogulec@wp.pl
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Department Name
- Rheumatology
- Principal Investigator Name
- Jan Brzezicki
- Principal Investigator Email
- b.brzezicka@gmail.com
- Contact Person Name
- Jan Brzezicki
- Contact Person Email
- b.brzezicka@gmail.com
- Site Name
- Klinika Reuma Park Sp. z o.o. S.K.
- Department Name
- Rheumatology
- Principal Investigator Name
- Anna Zubrzycka-Sienkiewicz
- Principal Investigator Email
- annazub1@wp.pl
- Contact Person Name
- Anna Zubrzycka-Sienkiewicz
- Contact Person Email
- annazub1@wp.pl
- Site Name
- Clinicmed Daniluk Nowak Sp. k.
- Department Name
- Internal medicine
- Principal Investigator Name
- Stephan Daniluk
- Principal Investigator Email
- daniluk@clinicmed.pl
- Contact Person Name
- Stephan Daniluk
- Contact Person Email
- daniluk@clinicmed.pl
- Site Name
- INTER CLINIC Piotr Adrian Klimiuk
- Department Name
- Rheumatology
- Principal Investigator Name
- Piotr Adrian Klimiuk
- Principal Investigator Email
- klimiuk_piotr@yahoo.com
- Contact Person Name
- Piotr Adrian Klimiuk
- Contact Person Email
- klimiuk_piotr@yahoo.com
- Site Name
- Rcmed Oddzial Sochaczew
- Department Name
- Rheumatology
- Principal Investigator Name
- Monika Wronisz
- Principal Investigator Email
- sochaczew@rcmed.com.pl
- Contact Person Name
- Monika Wronisz
- Contact Person Email
- sochaczew@rcmed.com.pl
- Site Name
- Prywatna Praktyka Lekarska Prof Dr Hab Med Pawel Hrycaj
- Department Name
- Rheumatology
- Principal Investigator Name
- Pawel Hrycaj
- Principal Investigator Email
- phrycaj@amp.edu.pl
- Contact Person Name
- Pawel Hrycaj
- Contact Person Email
- phrycaj@amp.edu.pl
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Department Name
- Rheumatology
- Principal Investigator Name
- Maria Jaraczewska-Baumann
- Principal Investigator Email
- kontakt@cr-center.pl
- Contact Person Name
- Maria Jaraczewska-Baumann
- Contact Person Email
- kontakt@cr-center.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- Rheumatology
- Principal Investigator Name
- Ewa Krecipro-Nizinska
- Principal Investigator Email
- Ewa.krecipro-nizinska@futuremeds.com
- Contact Person Name
- Ewa Krecipro-Nizinska
- Contact Person Email
- Ewa.krecipro-nizinska@futuremeds.com
- Site Name
- Reumed Sp. z o.o.
- Department Name
- N/D
- Principal Investigator Name
- Dariusz Chudzik
- Principal Investigator Email
- dariuszbchudzik@wp.pl
- Contact Person Name
- Dariusz Chudzik
- Contact Person Email
- dariuszbchudzik@wp.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 07-05-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 152
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Duca Liliana
- Principal Investigator Email
- office@neomed.org
- Contact Person Name
- Duca Liliana
- Contact Person Email
- office@neomed.org
- Site Name
- Medaudio-Optica S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Ionitescu Constantin Razvan
- Principal Investigator Email
- razvan1us@yahoo.com
- Contact Person Name
- Ionitescu Constantin Razvan
- Contact Person Email
- razvan1us@yahoo.com
- Site Name
- Spitalul Clinic Dr. I. Cantacuzino
- Department Name
- Internal Medicine and Rheumatology II
- Principal Investigator Name
- Claudia Silvia Ciofu
- Principal Investigator Email
- cantacuzino@spitalul-cantacuzino.ro
- Contact Person Name
- Claudia Silvia Ciofu
- Contact Person Email
- cantacuzino@spitalul-cantacuzino.ro
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 164
- Number Of Sites
- 7
- Number Of Participants
- 28
Sites
- Site Name
- Dcc 1 Sevlievo EOOD
- Department Name
- Not applicable
- Principal Investigator Name
- Dimitar Nikolov
- Principal Investigator Email
- dr.dimitar.nikolov@gmail.com
- Contact Person Name
- Dimitar Nikolov
- Contact Person Email
- dr.dimitar.nikolov@gmail.com
- Site Name
- Medical Center Teodora EOOD
- Department Name
- Not applicable
- Principal Investigator Name
- Margarita Velkova
- Principal Investigator Email
- dr_margarita_velkova@mail.bg
- Contact Person Name
- Margarita Velkova
- Contact Person Email
- dr_margarita_velkova@mail.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
- Department Name
- Department of Internal Diseases - Rheumatology
- Principal Investigator Name
- Dimitar Penev
- Principal Investigator Email
- d_penev@hotmail.com
- Contact Person Name
- Dimitar Penev
- Contact Person Email
- d_penev@hotmail.com
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Department Name
- Not applicable
- Principal Investigator Name
- Vladimira Boyadzhieva
- Principal Investigator Email
- vladimira.boyadzhieva@gmail.com
- Contact Person Name
- Vladimira Boyadzhieva
- Contact Person Email
- vladimira.boyadzhieva@gmail.com
- Site Name
- Medical Center Artmed Ltd.
- Department Name
- Not applicable
- Principal Investigator Name
- Mariela Geneva-Popova
- Principal Investigator Email
- genevapopova@yahoo.com
- Contact Person Name
- Mariela Geneva-Popova
- Contact Person Email
- genevapopova@yahoo.com
- Site Name
- Mbal Lyulin EAD
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Emil Dimitrov
- Principal Investigator Email
- dr_emildimitrov@mail.bg
- Contact Person Name
- Emil Dimitrov
- Contact Person Email
- dr_emildimitrov@mail.bg
- Site Name
- Medical Centre Epiona
- Department Name
- Not applicable
- Principal Investigator Name
- Rositza Karalilova
- Principal Investigator Email
- karalilova@hotmail.com
- Contact Person Name
- Rositza Karalilova
- Contact Person Email
- karalilova@hotmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 136
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Studienambulanz Rheumazentrum Ratingen GbR
- Department Name
- Studienambulanz
- Principal Investigator Name
- Siegfried Wassenberg
- Principal Investigator Email
- wassenberg@rhzr.de
- Contact Person Name
- Siegfried Wassenberg
- Contact Person Email
- wassenberg@rhzr.de
- Site Name
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
- Department Name
- Clinical research
- Principal Investigator Name
- Andrea Everding
- Principal Investigator Email
- studienzentrum@hotmail.com
- Contact Person Name
- Andrea Everding
- Contact Person Email
- studienzentrum@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Immunovant Sciences GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes 1, 5, 6
- Name
- Icon Laboratory Services Inc.
- Responsibilities
- sponsorDuties code 4
Third parties
- {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"sponsorDuties code 12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Avance Biosciences Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"sponsorDuties code 15 (eCOA and eDiary)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"sponsorDuties code 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"sponsorDuties code 15 (home care)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes 1, 5, 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code 15 (patient reimbursement services)","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- IMVT-1402
- Active Substance
- IMEROPRUBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 600 mg (max daily dose)
- Investigational Product Name
- Placebo is identical to IMP but with no active substance
- Modality
- Other
Related trials
Other published trials that may interest you.
- RITUXIMAB for Rheumatoid arthritis-associated interstitial lung disease|Rheumatoid arthritis
- SPY072 for Rheumatoid arthritis|Psoriatic arthritis|Axial spondyloarthritis
- LUTIKIZUMAB for Rheumatoid arthritis
- Rituximab for Rheumatoid Arthritis
- KYV-101 for ANCA-associated vasculitis|Granulomatosis with polyangiitis (GPA)|Microscopic polyangiitis (MPA)