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New lupus pill shows promise in Mid-Stage trial

NCT ID NCT03742037

Disease control Sponsor: Viatris Innovation GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tested four doses of cenerimod, a daily pill that calms the immune system, against a placebo in 427 adults with moderate-to-severe lupus. The main goal was to see if cenerimod could reduce lupus disease activity over six months. Researchers also checked for safety and how well participants tolerated the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cenerimod (a daily pill that calms the immune system)
What this could lead to
If it works, cenerimod could offer a new daily pill option to help control lupus flares and reduce disease activity.
What could go wrong
This is a mid-stage trial with only 427 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

427 people

The number who actually took part.

Started

Dec 2018

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed Informed Consent Form prior to any study-mandated procedure * Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria * A mSLEDAI-2K score ≥ 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). * Currently treated with stable doses of one or more of the following background medications: * NSAIDs * Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine) * Mycophenolate mofetil (≤ 2 g/day) * Mycophenolic acid (≤ 1440 mg/day) * Azathioprine (≤ 2 mg/kg/day) * Methotrexate (≤ 20 mg/week) * Corticosteroids (≤ 40 mg/day prednisone or equivalent) * Belimumab (≤10 mg/kg every 4 weeks intravenously, or 200 mg/week subcutaneously). * History or presence of positive autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre ≥1:80; AND/OR (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre ≥30 IU/mL * Women of childbearing potential: * Must have a negative serum pregnancy test at Screening * Must agree to undertake monthly urine pregnancy tests during the study * Must use highly effective methods of contraception from the screening visit until 6 months after taking the last dose of study treatment. Exclusion Criteria: * Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis. * CNS (Central Nervous System) lupus and severe forms of vasculitis requiring systemic immunosuppressive treatment * A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis * 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 six months prior to Screening * An elevated QT corrected for HR (Heart Rate) on the basis of Fridericia's formula interval of \> 470 ms (females) / \> 450 ms (males) * History or presence of severe respiratory disease or pulmonary fibrosis * Active or latent tuberculosis * Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection * Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing * Presence of macular edema or active uveitis * Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy * Significant hematology abnormality: Lymphocyte count \< 800 /μL (0.8 × 10e9/L); hemoglobin \< 9 g/dL; WBC (White Blood Cell) count \< 2500/μL (2.5 × 10e9/L) or platelets \< 75000/μL (75 × 10e9/L) * Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 * Known allergy to S1P (sphingosine-1-phosphate) receptor modulators or any of the cenerimod formulation excipients

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Conditions

The condition(s) this trial relates to.

connective tissue disorder systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • A.O. Mauriziano Umberto I di Torino

    Torino, Torino, 10128, Italy

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000, Mexico

  • Accurate Clinical Management

    Stafford, Texas, 77477, United States

  • Accurate Clinical Research

    Houston, Texas, 77034, United States

  • Advanced Research Institute Inc Allergy & Rheumatology

    St. Petersburg, Florida, 33708, United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124, United States

  • Angeles University Foundation Medical Center

    Angeles City, Philippines

  • Aversi Clinic LTD

    Tbilisi, 0160, Georgia

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33603, United States

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00158, Italy

  • Biológicos Especializados S.A. de C.V.

    Mexico City, 6700, Mexico

  • Biomedica Research Group

    Santiago, 7500710, Chile

  • Bnai Zion Medical Center

    Haifa, 3339419, Israel

  • CCR Pardubice

    Pardubice, Vychodocesky KRAJ, 530 02, Czechia

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Center for Rheumatology Immunology and Arthritis

    Fort Lauderdale, Florida, 33309, United States

  • Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest

    Brest, Brittany Region, 29609, France

  • Centro Integral en Reumatología S.A. de C.V.

    Guadalajara, 44160, Mexico

  • Centro Reumatologico de Caguas

    Caguas, 00725, Puerto Rico

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

    San Luis Potosí City, Mexico

  • Centro de Investigación Clínica GRAMEL, S.C.

    Mexico City, 03720, Mexico

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

    Brasov, 500283, Romania

  • Centrum Medyczne Plejady

    Krakow, 30-363, Poland

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076, Russia

  • City Clinical Hospital #15 named after O.M. Filatova

    Moscow, 111539, Russia

  • Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"

    Kyiv, 03151, Ukraine

  • Clinical Research Chile SpA

    Valdivia, 5110683, Chile

  • Clinical Rheumatological Hospital Number 25

    Saint Petersburg, 190068, Russia

  • Consultorio Médico del Dr. Federico Galván Villegas

    Guadalajara, 45040, Mexico

  • Consultorio Particular Dr. Miguel Cortés Hernández

    Cuernavaca, 62448, Mexico

  • Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá

    Guadalajara, 44650, Mexico

  • D&H National Research Centers INC

    Miami, Florida, 33155, United States

  • DJL Clinical Research

    Charlotte, North Carolina, 28210, United States

  • Davao Doctors Hospital

    Davao City, 8000, Philippines

  • Diagnostic Consulting Center Fokus-5

    Sofia, 1463, Bulgaria

  • Diagnostic and Consulting Center "Aleksandrovska" EOOD

    Sofia, 1431, Bulgaria

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet

    Budapest, Budapest, 1097, Hungary

  • Enroll SpA

    Santiago, 7500588, Chile

  • Far Eastern University - Nicanor Reyes Medical Foundation

    Quezon City, 1118, Philippines

  • Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"

    Moscow, 115522, Russia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168, Italy

  • Galilee Medical Center

    Nahariya, 2210001, Israel

  • General Hospital of Athens "Laiko"

    Goudi, 11527, Greece

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Quirónsalud Infanta Luisa

    Seville, SEVILLA, 41010, Spain

  • Hospital Universitario "Dr. Gonzalo Valdés Valdés"

    Saltillo, 25000, Mexico

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitario Regional de Málaga

    Málaga, MALAGA, 29009, Spain

  • Hôpital Haut-Lévêque

    Pessac, 33604, France

  • Icle S.C.

    Guadalajara, 44600, Mexico

  • Iloilo Doctors Hospital

    Iloilo City, 5000, Philippines

  • Innovative Health Research

    Las Vegas, Nevada, 89128, United States

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404, United States

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida, 33324, United States

  • Intermedius Uslugi Medyczne

    Kościan, 64-000, Poland

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, 45030, Mexico

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • JSC "Center of Family Medicine"

    Yekaterinburg, 620043, Russia

  • Joint Muscle Medical Care and Research Institute - Lilington Office

    Charlotte, North Carolina, 28204, United States

  • Jose R. Reyes Memorial Medical Center

    Manila, 1003, Philippines

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Karla Adriana Espinosa Bautista

    Mexico City, 01120, Mexico

  • Kohler & Milstein Research S.A. de C.V.

    Mérida, 97070, Mexico

  • Kyiv City Clinical Hospital №3

    Kyiv, 02125, Ukraine

  • LLC "Innova"

    Tbilisi, 0186, Georgia

  • LLC Raymann

    Tbilisi, 0186, Georgia

  • LTD "New Plasma Clinic"

    Batumi, 6010, Georgia

  • LTD "Tbilisi Heart Center"

    Tbilisi, 0186, Georgia

  • LUPUS CLINIC c/o DIMI

    Genova, 16132, Italy

  • Life Clinical Trials

    Margate, Florida, 33063, United States

  • Lipa Medix Medical Center

    Lipa City, Batangas, 4217, Philippines

  • Ltd. Mtskheta Street Clinic

    Tbilisi, 0179, Georgia

  • Lviv Regional Clinical Hospital

    Lviv, 79010, Ukraine

  • Makati Medical Center

    Makati City, 1229, Philippines

  • Medi Club Georgia Ltd.

    Tbilisi, 0160, Georgia

  • Medical Center "Health Clinic", LLC

    Vinnytsia, 21009, Ukraine

  • Medical Center "Zdorovaya Semiya", LLC

    Novosibirsk, 630099, Russia

  • Medical Center Maksimum Zdorovia

    Saint Petersburg, 650066, Russia

  • Medical Centre "Consilium medical"

    Kyiv, 04050, Ukraine

  • Medical Research Institute, LLC

    Saint Petersburg, 196006, Russia

  • Medicore

    Tbilisi, 0186, Georgia

  • Meditek Ltda.

    Santiago, 8330008, Chile

  • Military Medical Academy S.M. Kirov

    Saint Petersburg, 191045, Russia

  • Millennium Research

    Ormond Beach, Florida, 32174-1139, United States

  • Morales Vargas Centro de Investigación S.C.

    León, 37000, Mexico

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • Multiprofile Hospital For Active Treatment Trimontium

    Plovdiv, Plodiv, 4002, Bulgaria

  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital"

    Zaporizhzhya, 69600, Ukraine

  • Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"

    Kyiv, 04107, Ukraine

  • Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"

    Vinnytsia, 21018, Ukraine

  • Municipal Nonprofit Institution of Lviv Regional Council

    Lviv, 79000, Ukraine

  • Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"

    Lviv, 79000, Ukraine

  • Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"

    Zhytomyr, 10002, Ukraine

  • Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

    Konya, 42080, Turkey (Türkiye)

  • New York Presbyterian Columbia University Medical Center

    New York, New York, 10032, United States

  • Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways

    Moscow, 125315, Russia

  • North Georgia Rheumatology Group - Duluth

    Lawrenceville, Georgia, 30046, United States

  • Office of Ramesh C. Gupta, MD

    Memphis, Tennessee, 38119, United States

  • Orenburg State Medical University

    Orenburg, 460018, Russia

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Paramount Medical Research and Consulting

    Middleburg Heights, Ohio, 44130, United States

  • Pinnacle Research Group

    Anniston, Alabama, 36207, United States

  • Poltava Regional Clinical Hospital named after M.V. Sklifossovsky

    Poltava, 36011, Ukraine

  • Polyclinic of Private Security and Detectives

    Saint Petersburg, 192007, Russia

  • Private Small Scale Medical Center "Pulse"

    Vinnytsia, 21001, Ukraine

  • Prosalud

    Santiago, 8380456, Chile

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Rambam Healthcare Campus

    Haifa, 3109601, Israel

  • Robert W Levin MD PA

    Clearwater, Florida, 33765, United States

  • SC Sana Monitoring SRL

    Bucharest, 11025, Romania

  • SMIQ, S. de R.L. de C.V.

    Querétaro, 76070, Mexico

  • San Marcus Research Clinic

    Miami Lakes, Florida, 33014, United States

  • Saratov Regional Clinical Hospital

    Saratov, 410053, Russia

  • Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,

    Vinnytsia, 21029, Ukraine

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150, United States

  • Spitalul Clinic "Sf. Maria"

    Bucharest, 11172, Romania

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, 400006, Romania

  • St. Luke's Medical Center

    Quezon City, 1102, Philippines

  • State Institution of Health Protection "Clinical Hospital #8"

    Yaroslavl, 150030, Russia

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210, United States

  • Städtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133, Germany

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Szpital Specjalistyczny im. J. Dietla w Krakowie

    Krakow, 30-121, Poland

  • Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Ternopil University Clinic - Rheumatology department

    Ternopil, 46001, Ukraine

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • The First Medical Center Ltd.

    Tbilisi, 0180, Georgia

  • Tomakomai City Hospital

    Tomakomai-shi, 053-0034, Japan

  • Twoja Przychodnia Poznańskie Centrum Medyczne

    Poznan, 61-293, Poland

  • UBAM Unidad Biomédica Avanzada Monterrey

    Monterrey, 64460, Mexico

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, 97000, Mexico

  • Unidad de Investigaciones Reumatológicas A.C.

    San Luis Potosí City, 78290, Mexico

  • University Multiprofile Hospital for Active Treatment Pulmed

    Plovdiv, 4002, Bulgaria

  • University of California San Diego

    La Jolla, California, 92037-0493, United States

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

  • University of Santo Tomas Hospital

    Manila, 1015, Philippines

  • University of the Philippines Manila - Philippine General Hospital

    Manila, 1000, Philippines

  • Valerius Medical Group and Research Center

    Los Alamitos, California, 90720-5403, United States

  • Vinnytsya Regional Clinical Hospital - Rheumatology Department

    Vinnytsia, 21018, Ukraine

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department

    Uzhhorod, 88000, Ukraine

  • Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi

    Ustroń, 43-450, Poland

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