A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

NCT ID: NCT05648500

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2027-05-01

Brief Summary

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The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are:

* How well cenerimod works on top of the treatment already being administered.
* How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.

Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.

In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Detailed Description

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Conditions

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Lupus Erythematosus, Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cenerimod 4 mg

Participants will receive cenerimod once daily in addition to background SLE therapy.

Group Type EXPERIMENTAL

Cenerimod

Intervention Type DRUG

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

Matching placebo

Participants will receive matching placebo once daily in addition to background SLE therapy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Interventions

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Cenerimod

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

Intervention Type DRUG

Placebo

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Intervention Type DRUG

Other Intervention Names

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ACT-334441

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent Form (ICF) prior to any study-mandated procedure.
* Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.
* A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include "leukopenia".
* British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system.
* Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale.
* Currently treated with one or more of the following SLE background medications:

* Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine).
* Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day).
* Azathioprine (≤ 2 mg/kg/day).
* Methotrexate (≤ 25 mg/week).
* Oral Corticosteroids (OCS):

* if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
* if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
* Belimumab (≤10 mg/kg every 4 weeks intravenously \[i.v.\], or 200 mg/week subcutaneously \[s.c.\]).

Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening.

• For women of childbearing potential (WoCBP):

* Negative serum pregnancy test at Screening.
* Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.
* Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.


* A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
* BILAG Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system.
* PGA score ≥ 1.0 on a 0 to 3 visual analog scale.
* Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory):

* Anti-dsDNA antibodies elevated above normal,
* Antinuclear antibodies with a titer of at least 1:160,
* Anti-Smith antibody elevated above normal.
* Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization):

* Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine);
* Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day);
* Azathioprine (≤ 2 mg/kg/day);
* Methotrexate (≤ 25 mg/week);
* OCS:

* if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
* if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
* Belimumab (≤ 10 mg/kg every 4 weeks i.v. or ≤ 200 mg/week s.c.).
* WoCBP must have a negative urine pregnancy test at Randomization.

Exclusion Criteria

* Pregnant, planning to be become pregnant up to Final Study Visit, or lactating women.
* Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex:

* That would make the subject unable to fully understand the ICF; OR
* Where, in the opinion of the investigator/delegate, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.
* A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.
* History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.
* Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within 6 months prior to Screening.
* Resting heart rate \< 50 bpm as measured by the 12-lead ECG at Screening or at Randomization.
* An elevated QT interval corrected according to Fridericia's formula (QTcF) interval of \> 470 ms (females) / \> 450 ms (males) at Screening or at Randomization.
* History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history, lung function, and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.
* History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening.
* History or presence of malignancy (except for surgically excised and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma), lymphoproliferative disease, or history of total lymphoid irradiation within 10 years prior to Screening.
* Presence of any of the following abnormalities detected during the ophthalmological evaluation and/or by optical coherence tomography (OCT) during screening:

* Macular edema of any cause: diabetic, cystoid, tractional.
* Foveal degeneration, macular hole, macular pseudohole, hereditary or degenerative maculopathies.
* Active uveitis, papilledema.
* Retinal neovascularization of any cause and in any location.
* History of chronic liver or biliary disease (other than Gilbert's Syndrome) or subjects with alanine aminotransferase or aspartate aminotransferase \> 3 × Upper Limit of Normal (ULN) or total bilirubin \> 1.5 × ULN (unless in the context of known Gilbert's Syndrome).
* Significant hematology abnormality at screening assessment:

* lymphocyte count \< 500 /μL (0.5 × 10\^9/L);
* hemoglobin \< 7 g/dL;
* white blood cell count \< 2000/μL (2.0 × 10\^9/L); or
* platelets \< 25000/μL (25 × 10\^9/L).
* Estimated glomerular filtration rate \< 15 mL/min/1.73 m\^2.
* Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:

* β-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other anti-arrhythmic or heart-rate -lowering systemic therapy.
* QT-prolonging drugs with known risk of torsade de pointes irrespective of indication.
* Treatment with the following medications within 30 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:

* Cyclophosphamide, cyclosporine, voclosporin, tacrolimus, sirolimus, etc.
* Pulse methylprednisolone.
* Vaccination with live vaccines (including live vaccines for COVID-19).
* Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization.
* Treatment with the following medications within 90 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:

* Leflunomide.
* i.v. immunoglobulins.
* Treatment with any investigational agent within 90 days or 5 half-lives of the drug (whichever is longer) prior to Randomization.
* Treatment with B cell-depleting biological agents (e.g., rituximab or ocrelizumab) or biological immunosuppressive agents (e.g., anti-tumor necrosis factor \[TNF\], anti-interleukin \[IL\]-1, anti-IL6 therapies), within 12 months prior to Randomization.
* Treatment with anifrolumab within 6 months prior to Randomization.
* Treatment with any of the following medications any time prior to Screening:

* Alemtuzumab,
* Sphingosine-1-phosphate receptor modulators (e.g., fingolimod),
* Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viatris Innovation GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Viatris Innovation GmbH

Locations

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Providence Medical Foundation

Fullerton, California, United States

Site Status WITHDRAWN

California Research Institute

Huntington Park, California, United States

Site Status RECRUITING

University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

RASF-Clinical Research Inc.

Boca Raton, Florida, United States

Site Status WITHDRAWN

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status RECRUITING

Omega Research MetroWest, LLC

DeBary, Florida, United States

Site Status RECRUITING

SouthCoast Research Center, Inc.

Miami, Florida, United States

Site Status RECRUITING

IRIS Research and Development, LLC

Plantation, Florida, United States

Site Status RECRUITING

Renew Health Clinical Research LLC

Tampa, Florida, United States

Site Status WITHDRAWN

Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Advance Quality Medical Research

Orland Park, Illinois, United States

Site Status RECRUITING

Accurate Clinical Research Inc. - Lake Charles

Lake Charles, Louisiana, United States

Site Status RECRUITING

Louisiana State University School of Medicine section of Rheumatology

New Orleans, Louisiana, United States

Site Status NOT_YET_RECRUITING

Axon Clinical Research -Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, United States

Site Status WITHDRAWN

June DO, PC

Lansing, Michigan, United States

Site Status WITHDRAWN

Bronx Care Health and Wellness Center

The Bronx, New York, United States

Site Status RECRUITING

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

Site Status RECRUITING

Superior Clinical Reseach LLC

Smithfield, North Carolina, United States

Site Status WITHDRAWN

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, United States

Site Status NOT_YET_RECRUITING

Temple University Health Systems/ Lewis Katz School of Medicine

Philadelphia, Pennsylvania, United States

Site Status WITHDRAWN

Shelby Research, LLC

Memphis, Tennessee, United States

Site Status WITHDRAWN

Allen Arthritis

Allen, Texas, United States

Site Status WITHDRAWN

Accurate Clinical Research Inc.

Baytown, Texas, United States

Site Status RECRUITING

Rheumatology Care Center, PLLC

Bellaire, Texas, United States

Site Status RECRUITING

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status WITHDRAWN

Houston MD Medspa and Wellness Clinic

Houston, Texas, United States

Site Status RECRUITING

Accurate Clinical Research Inc.

Houston, Texas, United States

Site Status RECRUITING

Sun Research Institute

San Antonio, Texas, United States

Site Status RECRUITING

Fundación Respirar

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto Medico CER

Buenos Aires, , Argentina

Site Status RECRUITING

Aprillus Asistencia e Investigacion

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Ramos Mejia

Buenos Aires, , Argentina

Site Status RECRUITING

Arsema Clinica Adventista Belgrano

Buenos Aires, , Argentina

Site Status RECRUITING

IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología

Mendoza, , Argentina

Site Status RECRUITING

Instituto CAICI SRL

Rosario, , Argentina

Site Status RECRUITING

Centro de investigaciones medicas Tucuman

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Centro Integral de Reumatología

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

ICT (Investigaciones Clínicas Tucumán)

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Santa Casa de Belo Horizonte

Belo Horizonte, , Brazil

Site Status RECRUITING

Hospital Brasília

Brasília, , Brazil

Site Status WITHDRAWN

Centro Mineiro de Pesquisas

Juiz de Fora, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Instituto Méderi de Pesquisa e Saúde

Passo Fundo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

LMK Servicos Medico S/S

Porto Alegre, , Brazil

Site Status RECRUITING

IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas

Rio de Janeiro, , Brazil

Site Status ACTIVE_NOT_RECRUITING

SER - Serviços Especializados em Reumatologia da Bahia

Salvador, , Brazil

Site Status RECRUITING

Hospital de Clínicas de Porto Alegre

Santa Cecília, , Brazil

Site Status NOT_YET_RECRUITING

Centro Multidiciplinar de Estudos Clínicos- CEMEC

São Bernardo do Campo, , Brazil

Site Status NOT_YET_RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, , Brazil

Site Status RECRUITING

CPClin - Centro de Pesquisas Clínicas

São Paulo, , Brazil

Site Status RECRUITING

Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU

Uberlândia, , Brazil

Site Status RECRUITING

University Multi-profile Hospital for Active Treatment - Plovdiv AD

Plovdiv, , Bulgaria

Site Status RECRUITING

"University Multiprofile Hospital for Active Treatment - Pulmed" OOD

Plovdiv, , Bulgaria

Site Status RECRUITING

Medical Center ArtMed OOD

Plovdiv, , Bulgaria

Site Status WITHDRAWN

Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.

Plovdiv, , Bulgaria

Site Status RECRUITING

DCC 1 Ruse

Rousse, , Bulgaria

Site Status WITHDRAWN

DCC-1-Sevlievo EOOD

Sevlievo, , Bulgaria

Site Status RECRUITING

DCC "Sveta Anna" EOOD

Sofia, , Bulgaria

Site Status RECRUITING

Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost

Sofia, , Bulgaria

Site Status RECRUITING

DCC Equita EOOD

Varna, , Bulgaria

Site Status RECRUITING

Clínica de la costa Ltda.

Barranquilla, , Colombia

Site Status RECRUITING

Bluecare salud SAS

Bogotá, , Colombia

Site Status RECRUITING

IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)

Bogotá, , Colombia

Site Status RECRUITING

SERVIMED S.A.S Bucaramanga

Bucaramanga, , Colombia

Site Status RECRUITING

Fundación Valle de Lili

Cali, , Colombia

Site Status RECRUITING

Centro de Estudios de Reumatología y Dermatología

Cali, , Colombia

Site Status RECRUITING

Preventive Care SAS

Chía, , Colombia

Site Status RECRUITING

Hospital Pablo Tobón Uribe

Medellín, , Colombia

Site Status RECRUITING

Fundación Centro De Excelencia En Enfermedades Crónicas No Transmisibles-FUNCENTRA

Montería, , Colombia

Site Status WITHDRAWN

Healthy Medical Center SAS

Zipaquirá, , Colombia

Site Status RECRUITING

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status RECRUITING

CHU Félix Guyon Site Nord

Saint-Denis, , France

Site Status RECRUITING

CHU de Purpan

Toulouse, , France

Site Status RECRUITING

Naval Hospital of Athens

Athens, , Greece

Site Status RECRUITING

General Hospital of Athens "Hippokration"

Athens, , Greece

Site Status RECRUITING

General Hospital of Athens "Laiko"

Athens, , Greece

Site Status RECRUITING

University General Hospital "Attikon"

Athens, , Greece

Site Status RECRUITING

General University Hospital of Larissa

Larissa, , Greece

Site Status RECRUITING

General University Hospital of Patras

Pátrai, , Greece

Site Status RECRUITING

Euromedica - Kyanos Stavros

Thessaloniki, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, , Greece

Site Status RECRUITING

424 General Military Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Sangini Hospital

Ahmedabad, , India

Site Status RECRUITING

Rajiv Gandhi Government General Hospital

Chennai, , India

Site Status RECRUITING

Nizam's Institute of medical Sciences

Hyderabad, , India

Site Status RECRUITING

Maharaja Agrasen Superspeciality Hospital

Jaipur, , India

Site Status RECRUITING

Radiance Hospital

Nagpur, , India

Site Status RECRUITING

Shree Hospital and Critical Care Centre.

Nagpur, , India

Site Status RECRUITING

Assured Care Plus Hospital

Nashik, , India

Site Status RECRUITING

Coherence Pain & Arthritis Clinics

Pune, , India

Site Status RECRUITING

Vijaya Ortho & Trauma Centre

Sadashivnagar, , India

Site Status RECRUITING

Unity Hospital and Trauma Centre

Surat, , India

Site Status RECRUITING

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki-shi, , Japan

Site Status RECRUITING

National Hospital Organization Chiba Medical Center Chibahigashi National Hospital

Chiba, , Japan

Site Status RECRUITING

University of Yamanashi Hospital

Chuo-shi, , Japan

Site Status RECRUITING

St.Luke's International Hospital

Chūōku, , Japan

Site Status RECRUITING

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Site Status RECRUITING

Hiroshima Prefectural Hospital

Hiroshima, , Japan

Site Status RECRUITING

Hiroshima University Hospital

Hiroshima, , Japan

Site Status RECRUITING

Hitachi, Ltd. Hitachinaka General Hospital

Hitachi-Naka, , Japan

Site Status RECRUITING

National Kohnodai Medical Center, Japan Institute for Health Security

Ichikawa-shi, , Japan

Site Status RECRUITING

Tokai University Hospital

Isehara-shi, , Japan

Site Status RECRUITING

Kakogawa Central City Hospital

Kakogawa-shi, , Japan

Site Status RECRUITING

Shin-Kokura Hospital

Kitakyushu-shi, , Japan

Site Status RECRUITING

Kobe University Hospital

Kobe, , Japan

Site Status RECRUITING

Kobe City Medical Center General Hospital

Kobe, , Japan

Site Status RECRUITING

Kuwana City Medical Center

Kuwana-shi, , Japan

Site Status RECRUITING

Toho University - Ohashi Medical Center

Meguro-ku, , Japan

Site Status RECRUITING

University of Miyazaki Hospital

Miyazaki, , Japan

Site Status RECRUITING

Nagasaki University Hospital

Nagasaki, , Japan

Site Status RECRUITING

Chubu Rosai Hospital

Nagoya, , Japan

Site Status RECRUITING

Chukyo Hospital

Nagoya, , Japan

Site Status RECRUITING

Nagoya City University Hospital

Nagoya, , Japan

Site Status RECRUITING

IUHW Narita Hospital

Narita-shi, , Japan

Site Status NOT_YET_RECRUITING

Niigata University Medical and Dental Hospital

Niigata, , Japan

Site Status RECRUITING

Okayama City General Medical Center Okayama City Hospital

Okayama, , Japan

Site Status RECRUITING

Ome Medical Center

Ome-shi, , Japan

Site Status RECRUITING

Osaka Saiseikai Nakatsu Hospital

Osaka, , Japan

Site Status RECRUITING

Japanese Red Cross Saitama Hospital

Saitama-shi, , Japan

Site Status RECRUITING

Sainokuni Higashiomiya Medical Center

Saitama-shi, , Japan

Site Status RECRUITING

Toho University Sakura Medical Center

Sakura-shi, , Japan

Site Status RECRUITING

Hokkaido University Hospital

Sapporo, , Japan

Site Status RECRUITING

National Hospital Organization Hokkaido Medical Center

Sapporo, , Japan

Site Status RECRUITING

Tohoku Medical and Pharmaceutical University Hospital

Sendai, , Japan

Site Status RECRUITING

Showa Medical University East Hospital

Shinagawa-ku, , Japan

Site Status RECRUITING

Tokyo Women's Medical University Hospital

Shinjuku-ku, , Japan

Site Status RECRUITING

Tomakomai City Hospital

Tomakomai-shi, , Japan

Site Status RECRUITING

Yokohama City Minato Red Cross Hospital

Yokohama, , Japan

Site Status RECRUITING

Panamerican Clinical Research Mexico S.A. de C.V.

Cuernavaca, , Mexico

Site Status WITHDRAWN

Consultorio Privado de Especialidad

Guadalajara, , Mexico

Site Status RECRUITING

Centro de Estudios de Investigación Básica y Clínica, S.C.

Guadalajara, , Mexico

Site Status RECRUITING

Consultorio Médico de Reumatología - Hospital Aranda de la Parra

León, , Mexico

Site Status RECRUITING

Biológicos Especializados S.A. de C.V.

Mexico City, , Mexico

Site Status RECRUITING

CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.

Mexico City, , Mexico

Site Status RECRUITING

Unidad de Atención Médica e Investigación en Salud

Mérida, , Mexico

Site Status RECRUITING

Centro de Investigación Clínica Chapultepec S. A. de C. V.

Morelia, , Mexico

Site Status RECRUITING

SMIQ, S. de R.L. de C.V.

Querétaro, , Mexico

Site Status RECRUITING

Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

San Luis Potosí City, , Mexico

Site Status RECRUITING

Unidad de Investigaciones Reumatológicas A.C

San Luis Potosí City, , Mexico

Site Status NOT_YET_RECRUITING

Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

Zapopan, , Mexico

Site Status RECRUITING

Chong-Hua Hospital

Cebu City, , Philippines

Site Status RECRUITING

Davao Doctors Hospital

Davao City, , Philippines

Site Status RECRUITING

Mary Mediatrix Medical Center

Lipa, , Philippines

Site Status RECRUITING

Makati Medical Center

Makati, , Philippines

Site Status RECRUITING

UP-PGH

Manila, , Philippines

Site Status RECRUITING

Far Eastern University - Nicanor Reyes Medical Foundation

Quezon City, , Philippines

Site Status RECRUITING

Jose R. Reyes Memorial Medical Center

Santa Cruz, , Philippines

Site Status RECRUITING

INTER CLINIC Piotr Adrian Klimiuk

Bialystok, , Poland

Site Status RECRUITING

Centrum Medyczne Pratia Częstochowa

Częstochowa, , Poland

Site Status RECRUITING

Centrum Medyczne Angelius Provita

Katowice, , Poland

Site Status RECRUITING

Vita Longa Sp. z o.o.

Katowice, , Poland

Site Status RECRUITING

Małopolskie Badania Kliniczne

Krakow, , Poland

Site Status RECRUITING

Centrum Medyczne Plejady

Krakow, , Poland

Site Status RECRUITING

Velocity Nova Sp. z o. o.

Lublin, , Poland

Site Status RECRUITING

Zespół Poradni Specjalistycznych REUMED

Lublin, , Poland

Site Status RECRUITING

Malwa-Med Iwona Chlebicka

Wroclaw, , Poland

Site Status RECRUITING

Neomed Brasov

Brasov, , Romania

Site Status RECRUITING

SC Sana Monitoring SRL

Bucharest, , Romania

Site Status WITHDRAWN

Delta Health Care SRL

Bucharest, , Romania

Site Status RECRUITING

Spitalul Clinic Dr. Ion Cantacuzino

Bucharest, , Romania

Site Status WITHDRAWN

Spitalul Clinic Judetean de Urgentã Craiova

Craiova, , Romania

Site Status RECRUITING

SC Medaudio-Optica SRL

Râmnicu Vâlcea, , Romania

Site Status RECRUITING

Pusan National University Hospital

Busan, , South Korea

Site Status RECRUITING

Catholic University of Daegu (Daegu Catholic University Medical Center)

Daegu, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Junggu, , South Korea

Site Status RECRUITING

Hanyang University Hospital, Seongdong-gu

Seoul, , South Korea

Site Status RECRUITING

Ewha University Mokdong Hospital, Yangcheon-gu

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

KonKuk University Medical Center, Gwangjin-gu

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu

Seoul, , South Korea

Site Status RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Chi Mei Medical Center

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Cheng Hsin General Hospital

Taipei, , Taiwan

Site Status RECRUITING

TRI-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Vajira Hospital

Bangkok, , Thailand

Site Status RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status RECRUITING

Phramongkutklao Hospital (PMK)

Bangkok, , Thailand

Site Status RECRUITING

Rajavithi Hospital

Bangkok, , Thailand

Site Status RECRUITING

Ramathibodi Hospital

Bangkok, , Thailand

Site Status RECRUITING

Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology

Chiang Mai, , Thailand

Site Status RECRUITING

Srinagarind Hospital, Khon Kaen University

Khon Kaen, , Thailand

Site Status RECRUITING

Songklanagarind Hospital

Songkhla, , Thailand

Site Status RECRUITING

Fort Sunpasithiprasong Hospital

Ubon Ratchathani, , Thailand

Site Status RECRUITING

Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"

Cherkasy, , Ukraine

Site Status RECRUITING

Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council

Khmelnytskyi, , Ukraine

Site Status RECRUITING

Clinic of Modern Rheumatology

Kyiv, , Ukraine

Site Status RECRUITING

Kyiv City Clinical Hospital #3

Kyiv, , Ukraine

Site Status RECRUITING

Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"

Kyiv, , Ukraine

Site Status RECRUITING

State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin

Kyiv, , Ukraine

Site Status RECRUITING

Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center

Kyiv, , Ukraine

Site Status RECRUITING

Volyn Regional Clinical Hospital

Lutsk, , Ukraine

Site Status RECRUITING

Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni

Lviv, , Ukraine

Site Status RECRUITING

Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine

Lviv, , Ukraine

Site Status RECRUITING

Medical Centre "Academical Medical Group" LLC

Lviv, , Ukraine

Site Status RECRUITING

Uzhhorod City Multidisciplinary Clinical Hospital

Uzhhorod, , Ukraine

Site Status RECRUITING

Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department

Vinnytsia, , Ukraine

Site Status RECRUITING

Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"

Vinnytsia, , Ukraine

Site Status RECRUITING

Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"

Zhytomyr, , Ukraine

Site Status RECRUITING

Countries

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United States Argentina Brazil Bulgaria Colombia France Greece India Japan Mexico Philippines Poland Romania South Korea Taiwan Thailand Ukraine

Central Contacts

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Viatris Innovation Clinical Trial Information

Role: CONTACT

+1 908 435 2675

References

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Askanase AD, D'Cruz D, Kalunian K, Merrill JT, Navarra SV, Cahuzac C, Cornelisse P, Murphy MJ, Strasser DS, Trokan L, Berkani O. Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2025 Jan;7(1):e21-e32. doi: 10.1016/S2665-9913(24)00246-7. Epub 2024 Nov 22.

Reference Type DERIVED
PMID: 39586304 (View on PubMed)

Other Identifiers

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2022-002814-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-515870-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

ID-064A301

Identifier Type: -

Identifier Source: org_study_id

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