Clinical trial • Phase II • Immunology

IMEROPRUBART for Primary Sjögren's disease

Phase II trial of IMEROPRUBART for Primary Sjögren's disease.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Primary Sjögren's disease
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
01-08-2025
First CTIS Authorization Date
24-11-2025

Trial design

Randomised, imvt-1402 dose 1 subcutaneous (sc) once weekly (sc qw) compared to placebo (placebo is identical to imp but with no active substance).-controlled Phase II trial in Germany, Greece, Hungary and others.

Randomised
Yes
Comparator
IMVT-1402 dose 1 subcutaneous (SC) once weekly (SC QW) compared to Placebo (Placebo is identical to IMP but with no active substance).
Target Sample Size
108

Eligibility

Recruits 108 No vulnerable population selected. The study enrols adult participants only. Supporting Designee and Caregiver informed consent documents are provided in some country-specific materials (e.g. L1_SIS and ICF_Supporting Designee, L1_SIS and ICF_Caregiver in Italy), but paediatric/assent procedures are not applicable..

Vulnerable Population
No vulnerable population selected. The study enrols adult participants only. Supporting Designee and Caregiver informed consent documents are provided in some country-specific materials (e.g. L1_SIS and ICF_Supporting Designee, L1_SIS and ICF_Caregiver in Italy), but paediatric/assent procedures are not applicable.

Inclusion criteria

  • {"criterion_text":"- Have a diagnosis of primary SjD for a least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 ACR/EULAR Classification Criteria for Primary Sjogren’s Syndrome at the time of screening.\n- Have moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.\n- Are seropositive for antibodies to SSA/Ro at the Screening Visit.\n- Have residual salivary flow as measured by a stimulated whole salivary flow rate ≥ 0.01 mL/min at the Screening Visit."}

Exclusion criteria

  • {"criterion_text":"- Participants with a diagnosis of secondary SjD or an autoimmune disease other than primary SjD that constitutes the principal illness, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, pre-existing fibromyalgia or polymyositis, at the Screening Visit.\n- Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline in clinESSDAI score at Week 24.","definition_or_measurement_approach":"Change from baseline measured using the clinESSDAI total score at Week 24 (clinESSDAI assessed at baseline and Week 24)."}

Recruitment

Registry Or Advocacy Recruitment
True, Advocacy Group Sheet (no specific advocacy organisation name provided in documents).
Digital Remote Recruitment
True, includes social media ads, website postings/webposting, video concept materials, and use of e-diary (e-diary listed among patient-facing documents / sponsor duties).
Planned Sample Size
108
Recruitment Window Months
26
Consent Approach
Informed consent obtained from each adult participant. Subject information and informed consent forms (L1_SIS and ICF_Main) available in multiple languages (EN, DE, GR, HU, RO, ES, PL, IT). Optional genetic testing consent and pregnancy-specific consent forms are provided (country-specific). Supporting Designee and Caregiver ICF documents are included in some country packages (e.g. Supporting Designee, Caregiver forms), indicating procedures for designee/caregiver involvement where needed.

Methods

  • Social media advertisements (Social Media Ad PDFs per country: DE, GR, HU, IT, RO, PL, ES).
  • Posters and brochures (K2_Recruitment material_Poster_*/ K2_Recruitment material_Brochure_* files).
  • Website postings and website copy (General Trial Webposting and Website Copy PDFs per country).
  • Dear patient letters (country-specific Dear patient letter PDFs).
  • Advocacy group outreach (Advocacy Group Sheet PDFs).
  • Video concept (K2_Recruitment material_Video Concept_*).
  • Master marketing materials / Master Marketing_EC files.
  • Pre-screening support via third parties (e.g. Clariness GmbH listed with duty 'Pre-screening').
  • Master Screener / site screening materials (Master Screener_EC_* documents).

Geography

Total Number Of Sites
47
Total Number Of Participants
72

Germany

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
144
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Medicover GmbH
Department Name
Medicover München Ost MVZ
Contact Person Name
David Kofler
Contact Person Email
david.kofler@medicover.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik V, Sektion Rheumatologie
Contact Person Name
Norbert Blank
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma Forschungszentr um II
Contact Person Name
Andrea Everding
Contact Person Email
studienzentrum@hotmail.com
Site Name
Medizinische Hochschule Hannover
Department Name
Rheumatologisch e Studienambulanz
Contact Person Name
Torsten Witte
Site Name
LMU Klinikum Muenchen AöR
Department Name
Department rheumatology and clinical immunology
Contact Person Name
Hendrik Schulze-Koops
Site Name
Prof. Dr. med. Gunther Neeck MVZ GmbH
Department Name
Rheumazentrum
Contact Person Name
Gunther Neeck

Greece

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
192
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Laiko General Hospital Of Athens
Department Name
Department of Pathophysiology
Contact Person Name
Athanasios Tzioufas
Contact Person Email
agtzi@med.uoa.gr
Site Name
Athens Euroclinic S.A.
Department Name
Department of Internal Medicine and Autoimmune Diseases
Contact Person Name
Foteini Skopouli
Contact Person Email
fskopouli@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
145
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Revita Kft.
Contact Person Name
Márta Megyaszai
Contact Person Email
m.megyaszai@gmail.com
Site Name
Complex Rendelo Med Zrt.
Contact Person Name
Kata Kerekes
Contact Person Email
drkerekeskata@yahoo.com
Site Name
Je-Med Bt.
Contact Person Name
Edit Sebők
Contact Person Email
sebokditke@gmail.com
Site Name
Vasarhelyi Sarkanyfu Kft.
Contact Person Name
Éva Balázs
Contact Person Email
jimbies@gmail.hu

Italy

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
192
Number Of Sites
11
Number Of Participants
11

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare
Contact Person Name
Marco Matucci Cerinic
Contact Person Email
MatucciCerinic.Marco@hsr.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
U.O.C. Reumatologia
Contact Person Name
Giovanni Orsolini
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O. Reumatologia
Contact Person Name
Rosario Foti
Contact Person Email
rfoti5@gmail.com
Site Name
Hospital Santa Maria Della Misericordia
Department Name
SC Reumatologia
Contact Person Name
Elena Bartoloni Bocci
Contact Person Email
elena.bartolonibocci@unipg.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
U.O. Reumatologia
Contact Person Name
Giuliana Guggino
Contact Person Email
giuliana.guggino@unipa.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Reumatologia
Contact Person Name
Francesco Ciccia
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
UOC Immunoreumatologia
Contact Person Name
Roberto Giacomelli
Site Name
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare (additional listed site)
Site Name
Additional Italy site
Site Name
Additional Italy site
Site Name
Additional Italy site

Romania

Earliest CTIS Part Ii Submission Date
17-11-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
113
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Saint Maria Hospital
Department Name
Internal Medicine I
Contact Person Name
Florian Berghea
Contact Person Email
secretariat@spitalsfmaria.ro
Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
Rheumatology
Contact Person Name
Liliana Duca
Contact Person Email
office@neomed.org
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Rheumatology
Contact Person Name
Simona Rednic
Contact Person Email
srednic@umfcluj.ro

Poland

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
08-03-2026
Processing Time Days
191
Number Of Sites
15
Number Of Participants
24

Sites

Site Name
Magdalena Gołąbek
Department Name
Pracownia Badań Klinicznych Salus
Contact Person Name
Katarzyna Rachwał-Siek
Contact Person Email
biuro@pbks.com.pl
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Joanna Dmowska-Chalaba
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Bydgoszcz)
Department Name
MICS Centrum Medyczne Bydgoszcz
Contact Person Name
Katarzyna Kolossa
Contact Person Email
marta.jeka@medicover.com
Site Name
ETG Lublin Sp. z o.o.
Department Name
ETG Lublin Poradnie Specjalistyczne
Contact Person Name
Arkadiusz Koszarny
Contact Person Email
lublin@etg-network.com
Site Name
Futuremeds Sp. z o.o.
Department Name
FutureMeds Łódź
Contact Person Name
Katarzyna Bartnicka-Masłowska
Contact Person Email
info.lodz@futuremeds.com
Site Name
Lukmed 2 Sp. z o.o.
Department Name
ETG Siedlce
Contact Person Name
Tomasz Bocianowski
Contact Person Email
siedlce@etg-network.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
Specjalista w dziedzinie alergologii, immunologii klinicznej i chorób wewnętrznych
Contact Person Name
Magdalena Celińska-Löwenhoff
Contact Person Email
cmplejady@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Uniwersyteckie Centrum Wsparcia Badań Klinicznych
Contact Person Name
Piotr Wiland
Contact Person Email
badaniakliniczne@usk.wroc.pl
Site Name
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
Contact Person Name
Paweł Hrycaj
Contact Person Email
pawel.hrycaj@gmail.com
Site Name
Michalski I Partnerzy Lekarze sp.p.
Contact Person Name
Joanna Michalska
Site Name
Reumed Sp. z o.o.
Department Name
Zespół Poradni Specjalistycznych Reumed, Filia nr 1 Wallenroda
Contact Person Name
Dariusz Chudzik
Contact Person Email
reumedlublinpl@gmail.com
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Contact Person Name
Anna Zubrzycka-Sienkiewicz
Contact Person Email
info@reumatika.pl
Site Name
K2J2 Katarzyna Viktoria Jachimowska
Department Name
Centrum Medyczne K2J2
Contact Person Name
Katarzyna Kamińska- Stachniak
Contact Person Email
badaniakliniczne@k2j2.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Warsaw)
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Małgorzata Gryka-Marton
Contact Person Email
kontakt@medycynakliniczna.pl
Site Name
Etg Warszawa Sp. z o.o.
Department Name
ETG Warszawa
Contact Person Name
Anna Rowińska-Osuch
Contact Person Email
warszawa@etg-network.com

Spain

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
168
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Hospital Universitario Basurto
Department Name
Rheumatology
Contact Person Name
Ana Rosa Inchaurbe Pellejero
Site Name
Hospital De Merida
Department Name
Rheumatology
Contact Person Name
Raul Veroz Gonzalez
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Rheumatology
Contact Person Name
Isabel de la Morena Barrio
Contact Person Email
isabel.morena@uv.es
Site Name
Futuremeds Spain S.L.
Department Name
Rheumatology
Contact Person Name
Raùl Moreno Dominguez
Contact Person Email
Raul.moreno@futuremeds.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Rheumatology
Contact Person Name
Ignacio Gomez Garcia
Contact Person Email
ignaciogomgar@gmail.com
Site Name
Hospital (additional Spain site)

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
Site Training, HHC, Patient Reimbursement, Equipment
Name
PRA Hellas CRO A.E.
Responsibilities
code:1; code:5
Name
Suvoda LLC
Responsibilities
code:3

Third parties

  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement services","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Site Training, HHC, Patient Reimbursement, Equipment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Exagen Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Pre-screening","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Long-term storage facility","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"Long-term storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"code:1; code:5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Avance Biosciences Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Laboratories (additional country entry)","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"e-diary","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
IMVT-1402
Active Substance
IMEROPRUBART
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Frequency
Once weekly (SC QW)
Maximum Dose
600 mg
Investigational Product Name
Placebo is identical to IMP but with no active substance
Modality
Other

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