Clinical trial • Phase III • Immunology

CENERIMOD for Systemic lupus erythematosus

Phase III trial of CENERIMOD for Systemic lupus erythematosus. open-label. 663 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-06-2024
First CTIS Authorization Date
20-09-2024

Trial design

open-label Phase III trial across 47 sites in Bulgaria, Czechia, France and others.

Open Label
Yes
Target Sample Size
663
Trial Duration For Participant
545-1275

Eligibility

Recruits 663 Vulnerable population is indicated as selected. Informed consent must be a signed and dated informed consent form prior to any study-mandated procedure. Participants are adults (aged 18-75). Subject information and ICF documents (L1_SIL-ICF Core and related materials) are provided in multiple country-specific languages (examples present in the dossier: EN, BG, CZ, EL, ES, FR, PL, PT, RO, DE). No separate assent procedures for minors are described..

Pregnancy Exclusion
Women of child-bearing potential planning to become pregnant up to the final study visit.
Vulnerable Population
Vulnerable population is indicated as selected. Informed consent must be a signed and dated informed consent form prior to any study-mandated procedure. Participants are adults (aged 18-75). Subject information and ICF documents (L1_SIL-ICF Core and related materials) are provided in multiple country-specific languages (examples present in the dossier: EN, BG, CZ, EL, ES, FR, PL, PT, RO, DE). No separate assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- Signed and dated informed consent form prior to any study-mandated procedure."}
  • {"criterion_text":"- Male and female participants (aged 18-75 years) with a diagnosis of systemic lupus erythematosus who: • Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302). • Did not meet any study treatment stopping criteria during the parent study. • Completed the last scheduled visit of the parent study. Participants who did not complete the last scheduled visit for reasons beyond their control maybe eligible for this study upon approval by the sponsor."}
  • {"criterion_text":"- For women of child-bearing potential: • Negative pregnancy test at Visit 1. • Agreement to undertake monthly urine pregnancy tests from Visit 2 up to 6 months after study treatment discontinuation. • Agreement to use a highly effective method of contraception from Visit 1 up to 6 months after study treatment discontinuation."}

Exclusion criteria

  • {"criterion_text":"- Poor compliance with study-mandated procedures during the parent study (ID-064A301 or ID-064A302),e.g., took less than 80% of the planned doses of double-blind study treatment; or did not attend a majority of the site visits, unless there was a medically justified reason as judged by the investigator."}
  • {"criterion_text":"- Systemic lupus erythematosus driven renal disease, central nervous system lupus, or active severe or unstable neuropsychiatric systemic lupus erythematosus where, in the judgment of the investigator, protocol-specific systemic lupus erythematosus background therapy is insufficient, and the use of a more aggressive therapeutic approach or other treatments not permitted in the protocol is indicated."}
  • {"criterion_text":"- Women of child-bearing potential planning to become pregnant up to the final study visit."}
  • {"criterion_text":"- Judged not eligible to participate by the investigator, for any other reason."}
  • {"criterion_text":"- Confirmed active or latent tuberculosis (applicable only if requested by local regulations)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Occurrence of treatment-emergent adverse events up to the final study visit.","definition_or_measurement_approach":"Occurrence measured as incidence of treatment-emergent adverse events reported from first dose through the final study visit."}
  • {"endpoint_text":"- Occurrence of serious adverse events up to the final study visit.","definition_or_measurement_approach":"Occurrence measured as incidence of serious adverse events reported from first dose through the final study visit."}
  • {"endpoint_text":"- Occurrence of adverse events of special interest (i.e., anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities) up to the final study visit.","definition_or_measurement_approach":"Occurrence measured as incidence of predefined adverse events of special interest (anticipated risks/class effects/comorbidities) reported from first dose through the final study visit."}

Recruitment

Planned Sample Size
663
Recruitment Window Months
44
Consent Approach
Signed and dated informed consent form required prior to any study-mandated procedure; participants must provide consent themselves (adult population, 18-75 years). ICF core and supplementary documents (e.g., 'Women becoming pregnant' information) are available in multiple country-specific languages (documents present in EN, BG, CZ, EL, ES, FR, PL, PT, RO, DE). No assent process for minors is described.

Geography

Total Number Of Sites
47
Total Number Of Participants
172

Bulgaria

Earliest CTIS Part Ii Submission Date
26-06-2024
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
560
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Diagnostic Consultative Center Equita OOD
Department Name
Diagnostic Consultative Center Equita
Contact Person Name
Daniela Kamburova
Contact Person Email
dcc.equita@gmail.com
Site Name
Ambulatories For Specialized Outpatient Medical Help Medical Center Kyuchuk Parizh OOD
Department Name
Ambulatories For Specialized Outpatient Medical Help Medical Center Kyuchuk Parizh
Contact Person Name
Nedyalka Staykova
Contact Person Email
mc.k.parij@abv.bg
Site Name
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Department Name
Acibadem City Clinic Diagnostic And Consultation Center
Contact Person Name
Delina Ivanova
Contact Person Email
delina_ivanov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Rheumatology Clinic
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
470
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Revmatologicky Ustav
Department Name
Revmatologický ustav
Contact Person Name
Dana Tegzová
Contact Person Email
tegzova@revma.cz
Site Name
iMedica s.r.o.
Department Name
iMedica, s.r.o.
Contact Person Name
Angelika Lapčíková
Contact Person Email
int.ambulance@gmail.com

France

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
483
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire De La Reunion
Department Name
Service de Médecine Interne
Contact Person Name
Loïc Raffray
Contact Person Email
loic.raffray@chu-reunion.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Médecine Interne
Contact Person Name
Laurent Sailler
Contact Person Email
sailler.l@chu-toulouse.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Service de Médecine Interne 2
Contact Person Name
Zahir Amoura
Contact Person Email
zahir.amoura@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
16-08-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
488
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Universitaetsklinikum Muenster AöR
Department Name
Sektion für Rheumatologie und klinische Immunologie, Medizinische Klinik D
Contact Person Name
Gert Gabriels
Contact Person Email
eva.mickholz@ukmuenster.de
Site Name
Johannes Wesling Klinikum Minden
Department Name
Studiensekretariat Rheumatologie, Klinik für Rheumatologie und Klinische Immunologie
Contact Person Name
Gunter Aßmann
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
ITMP
Contact Person Name
Michaela Köhm
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Studienambulanz Rheumatologie, Klinik & Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
Contact Person Name
Ulf Wagner
Contact Person Email
rheuma@medizin.uni-leipzig.de

Portugal

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
482
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Internal Medicine
Contact Person Name
Gloria Alves
Contact Person Email
gloriasousalves@gmail.com
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Rheumatology
Contact Person Name
Célia Ribeiro
Contact Person Email
caribeiro@ulsalg.min-saude.pt
Site Name
Unidade Local De Saude Da Guarda E.P.E.
Department Name
Rheumatology
Contact Person Name
Claudia Vaz
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Rheumatology
Contact Person Name
Patricia Pinto
Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Autoimmune unit
Contact Person Name
José Alves
Contact Person Email
Jose.alves@nms.unl.pt

Romania

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
475
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Medaudio-Optica S.R.L.
Department Name
Medart Cliniq Reumatologie
Contact Person Name
Răzvan Ionițescu
Contact Person Email
razvan1us@yahoo.com
Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
Secția Reumatologie
Contact Person Name
Liliana Duca
Contact Person Email
office@neomed.org
Site Name
Spitalul Clinic Judetean De Urgenta Craiova
Department Name
Secția Reumatologie
Contact Person Name
Florentin Ananu Vreju
Contact Person Email
florin_vreju@yahoo.com
Site Name
Delta Health Care S.R.L.
Department Name
Secția Reumatologie
Contact Person Name
Bogdan-Horia Chicos
Contact Person Email
alis.mihai@reginamaria.ro

Poland

Earliest CTIS Part Ii Submission Date
17-09-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
461
Number Of Sites
11
Number Of Participants
40

Sites

Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
"Szpital Biziela" Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Contact Person Name
Piotr Ignaczak
Contact Person Email
pmi@autograf.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Katarzyna Romanowska-Próchnicka
Site Name
Iwona Chlebicka Malwa-Med Iwona Chlebicka
Department Name
Malwa-Med Iwona Chlebicka
Contact Person Name
Jacek Szepietowski
Contact Person Email
iwonak4wsk@interia.pl
Site Name
Piotr Leszczyński Medyczne Centrum Hetmańska Piotr Leszczyński
Department Name
Medyczne Centrum Hetmańska Piotr Leszczyński
Contact Person Name
Piotr Leszczyński
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia Poznańskie Centrum Medyczne
Contact Person Name
Agata Wytyk-Nowak
Contact Person Email
wytyk@twojaprzychodnia.com
Site Name
Provita Sp. z o.o.
Department Name
Centrum Medyczne Angelius Provita – Badania Kliniczne
Contact Person Name
Magdalena Włoch-Targońska
Contact Person Email
wloch.magdalena@gmail.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
Centrum Medyczne Plejady
Contact Person Name
Magdalena Celińska-Lowenhoff
Contact Person Email
magdalena.lowenhoff@gmail.com
Site Name
Vita Longa Sp. z o.o.
Department Name
Niepubliczny Zakład Opieki Zdrowotnej "Vita longa" Sp. Z o.o.
Contact Person Name
Joanna Głogowska-Szeląg
Site Name
Reumed Sp. z o.o.
Department Name
Zespół Poradni Specjalistycznych REUMED
Contact Person Name
Mariusz Piotrowski
Contact Person Email
mariusz_piotrowski@yahoo.com
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Częstochowa
Contact Person Name
Renata Wysocka-Znojkiewicz
Contact Person Email
rwysocka@pratia.pl
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Department Name
Małopolskie Badania Kliniczne
Contact Person Name
Bogdan Batko
Contact Person Email
bpbatko@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
569
Number Of Sites
9
Number Of Participants
23

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
4th Pathology Clinic
Contact Person Name
Dimitrios Boumpas
Contact Person Email
boumpasd@uoc.gr
Site Name
General University Hospital Of Larissa
Department Name
Clinic of Rheumatology and Clinical Immunology
Contact Person Name
Christina Katsiari
Contact Person Email
cgk2005@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
Rheumatology Department - 1st Department of Propaedeutic Internal Medicine Clinic
Contact Person Name
Petros Sfikakis
Contact Person Email
psfikakis@med.uoa.gr
Site Name
General University Hospital Of Patras
Department Name
Rheumatology Department
Contact Person Name
Stamatis Nicolaos Liossis
Contact Person Email
snliossis@med.upatras.gr
Site Name
Euromedica Kyanous Stavros
Department Name
Rheumatology Department
Contact Person Name
Loukas Settas
Contact Person Email
loukassettas@gmail.com
Site Name
Hippokration Hospital (Athens)
Department Name
2nd Department of Medicine, University of Athens, School of Medicine
Contact Person Name
Dimitrios Vassilopoulos
Contact Person Email
dvassilop@med.uoa.gr
Site Name
Hippokration Hospital (Thessaloniki)
Department Name
4th Internal Medicine Clinic
Contact Person Name
Theodoros Dimitroulas
Contact Person Email
dimitroul@hotmail.com
Site Name
Athens Naval Hospital
Department Name
Rheumatology Clinic
Contact Person Name
Gkikas Katsifis
Contact Person Email
katsifis@yahoo.gr
Site Name
424 Military General Training Hospital
Department Name
Rheumatology Department
Contact Person Name
Grigorios Sakellariou
Contact Person Email
sakelgr@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
617
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Accellacare Espana S.L.
Department Name
Rheumatology
Contact Person Name
Raul Veiga
Contact Person Email
grupo9123@hotmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Rheumatology
Contact Person Name
Lydia Abasolo
Contact Person Email
lydia.abasolo@salud.madrid.org
Site Name
Clinica Gaias Santiago
Department Name
Rheumatology
Contact Person Name
Juan Antonio Garcia Meijide
Contact Person Email
meijithe@hotmail.com
Site Name
Hospital Universitario Rio Hortega
Department Name
Autoinmmune Diseases
Contact Person Name
Maria Julia Barbado Ajo
Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology
Contact Person Name
Joan Calvet Fontova
Contact Person Email
joan.calvet.fontova@gmail.com

Sponsor

Primary sponsor

Full Name
Viatris Innovation GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
Central ECG
Name
Almac Clinical Technologies LLC
Responsibilities
Responsibilities listed (code 3) in dossier
Name
Next CRO SYMVOULOI FARMAKEUTIKON EPICHEIRISEON M.E.P.E.
Responsibilities
Multiple operational roles including first point of contact for contracts/agreements with hospitals, investigators, and other parties as required for the conduct of the study.
Name
MEDPACE LABORATORIES
Responsibilities
Laboratory testing responsibilities (code 4)
Name
Winicker-Norimed Medizinische Forschung GmbH
Responsibilities
Administrative Support

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Swiss Tropical And Public Health Institute (Swiss TPH)","duties_or_roles":"Biobank Storage facility","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"code 10","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Crisalis LLC","duties_or_roles":"Investigator learning portal for questionnaires","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"Next CRO SYMVOULOI FARMAKEUTIKON EPICHEIRISEON M.E.P.E.","duties_or_roles":"First point of contact for contracts/agreements with hospitals, investigators, and other parties as required for the conduct of the study.; other duties codes present: 1,12,2,5","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Flying Study Team GbR","duties_or_roles":"code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Keyrus Life Science Innovation","duties_or_roles":"Biostatistics; code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Precision for Medicine (HU) Kft.","duties_or_roles":"Contact for contracts with hospitals, investigators, other parties as required","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient expenses reimbursement, Patient travel booking","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Portugal","full_name":"Leon Research S.L. Sucursal Em Portugal","duties_or_roles":"Contact for contracts with hospitals, investigators, other parties as required","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Winicker-Norimed Medizinische Forschung GmbH","duties_or_roles":"Administrative Support; code 5","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Competence In Scientific Services Eggenreich & Gschanes GmbH","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Cenerimod 4 mg
Active Substance
CENERIMOD
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
1
Starting Dose
4 mg
Dose Levels
4 mg
Frequency
once daily
Maximum Dose
4 mg
Combination Treatment
Yes

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