AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 2NCT03742037

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Phase 2 study testing Cenerimod 0.5 mg, Cenerimod 1 mg and Cenerimod 2 mg in people with Systemic Lupus Erythematosus, run by Viatris Innovation GmbH at 148 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Cenerimod 0.5 mg, Cenerimod 1 mg and Cenerimod 2 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
427 participants
Where
148 sitesin 24 countries
Study dates
21 Dec 2018to 25 Aug 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

148 sites in 24 countries.

148 sites in 24 countries

United States29 sites

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

  • Joint Muscle Medical Care and Research Institute - Lilington Office

    Charlotte, North Carolina, 28204

  • DJL Clinical Research

    Charlotte, North Carolina, 28210

  • Robert W Levin MD PA

    Clearwater, Florida, 33765

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Center for Rheumatology Immunology and Arthritis

    Fort Lauderdale, Florida, 33309

  • Accurate Clinical Research

    Houston, Texas, 77034

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • University of California San Diego

    La Jolla, California, 92037-0493

  • Innovative Health Research

    Las Vegas, Nevada, 89128

  • North Georgia Rheumatology Group - Duluth

    Lawrenceville, Georgia, 30046

  • Valerius Medical Group and Research Center

    Los Alamitos, California, 90720-5403

  • Life Clinical Trials

    Margate, Florida, 33063

  • Office of Ramesh C. Gupta, MD

    Memphis, Tennessee, 38119

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • D&H National Research Centers INC

    Miami, Florida, 33155

  • San Marcus Research Clinic

    Miami Lakes, Florida, 33014

  • Paramount Medical Research and Consulting

    Middleburg Heights, Ohio, 44130

  • New York Presbyterian Columbia University Medical Center

    New York, New York, 10032

  • Millennium Research

    Ormond Beach, Florida, 32174-1139

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida, 33324

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Advanced Research Institute Inc Allergy & Rheumatology

    St. Petersburg, Florida, 33708

  • Accurate Clinical Management

    Stafford, Texas, 77477

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33603

Other trials in United States

Mexico18 sites

  • Consultorio Particular Dr. Miguel Cortés Hernández

    Cuernavaca, 62448

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

    Guadalajara, 44160

  • Icle S.C.

    Guadalajara, 44600

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

    Guadalajara, 44650

  • Consultorio Médico del Dr. Federico Galván Villegas

    Guadalajara, 45040

  • Morales Vargas Centro de Investigación S.C.

    León, 37000

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, 97000

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

    Mérida, 97070

  • Karla Adriana Espinosa Bautista

    Mexico City, 01120

  • Centro de Investigación Clínica GRAMEL, S.C.

    Mexico City, 03720

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

    Mexico City, 6700

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000

  • UBAM Unidad Biomédica Avanzada Monterrey

    Monterrey, 64460

  • SMIQ, S. de R.L. de C.V.

    Querétaro, 76070

  • Hospital Universitario "Dr. Gonzalo Valdés Valdés"

    Saltillo, 25000

  • Unidad de Investigaciones Reumatológicas A.C.

    San Luis Potosí City, 78290

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

    San Luis Potosí City

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

    Zapopan, 45030

Other trials in Mexico

Ukraine17 sites

  • Kyiv City Clinical Hospital №3

    Kyiv, 02125

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

    Kyiv, 03151

  • Medical Centre "Consilium medical"

    Kyiv, 04050

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

    Kyiv, 04107

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

    Lviv, 79000

  • Municipal Nonprofit Institution of Lviv Regional Council

    Lviv, 79000

  • Lviv Regional Clinical Hospital

    Lviv, 79010

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

    Poltava, 36011

  • Ternopil University Clinic - Rheumatology department

    Ternopil, 46001

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

    Uzhhorod, 88000

  • Private Small Scale Medical Center "Pulse"

    Vinnytsia, 21001

  • Medical Center "Health Clinic", LLC

    Vinnytsia, 21009

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

    Vinnytsia, 21018

  • Vinnytsya Regional Clinical Hospital - Rheumatology Department

    Vinnytsia, 21018

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

    Vinnytsia, 21029

  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital"

    Zaporizhzhya, 69600

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

    Zhytomyr, 10002

Other trials in Ukraine

Russia14 sites

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076

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

    Moscow, 111539

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

    Moscow, 115522

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

    Moscow, 125315

  • Medical Center "Zdorovaya Semiya", LLC

    Novosibirsk, 630099

  • Orenburg State Medical University

    Orenburg, 460018

  • Clinical Rheumatological Hospital Number 25

    Saint Petersburg, 190068

  • Military Medical Academy S.M. Kirov

    Saint Petersburg, 191045

  • Polyclinic of Private Security and Detectives

    Saint Petersburg, 192007

  • Medical Research Institute, LLC

    Saint Petersburg, 196006

  • Medical Center Maksimum Zdorovia

    Saint Petersburg, 650066

  • Saratov Regional Clinical Hospital

    Saratov, 410053

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

    Yaroslavl, 150030

  • JSC "Center of Family Medicine"

    Yekaterinburg, 620043

Other trials in Russia

Georgia10 sites

  • LTD "New Plasma Clinic"

    Batumi, 6010

  • Aversi Clinic LTD

    Tbilisi, 0160

  • Medi Club Georgia Ltd.

    Tbilisi, 0160

  • Ltd. Mtskheta Street Clinic

    Tbilisi, 0179

  • The First Medical Center Ltd.

    Tbilisi, 0180

  • LLC "Innova"

    Tbilisi, 0186

  • LLC Raymann

    Tbilisi, 0186

  • LTD "Tbilisi Heart Center"

    Tbilisi, 0186

  • Medicore

    Tbilisi, 0186

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

Other trials in Georgia

Philippines10 sites

  • Angeles University Foundation Medical Center

    Angeles City

  • Davao Doctors Hospital

    Davao City, 8000

  • Iloilo Doctors Hospital

    Iloilo City, 5000

  • Lipa Medix Medical Center

    Lipa City, Batangas, 4217

  • Makati Medical Center

    Makati City, 1229

  • University of the Philippines Manila - Philippine General Hospital

    Manila, 1000

  • Jose R. Reyes Memorial Medical Center

    Manila, 1003

  • University of Santo Tomas Hospital

    Manila, 1015

  • St. Luke's Medical Center

    Quezon City, 1102

  • Far Eastern University - Nicanor Reyes Medical Foundation

    Quezon City, 1118

Other trials in Philippines

Italy6 sites

  • LUPUS CLINIC c/o DIMI

    Genova, 16132

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00158

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168

  • A.O. Mauriziano Umberto I di Torino

    Torino, Torino, 10128

Other trials in Italy

Poland6 sites

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

    Bydgoszcz, 85-168

  • Intermedius Uslugi Medyczne

    Kościan, 64-000

  • Szpital Specjalistyczny im. J. Dietla w Krakowie

    Krakow, 30-121

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Twoja Przychodnia Poznańskie Centrum Medyczne

    Poznan, 61-293

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

    Ustroń, 43-450

Other trials in Poland

Chile5 sites

  • Enroll SpA

    Santiago, 7500588

  • Biomedica Research Group

    Santiago, 7500710

  • Meditek Ltda.

    Santiago, 8330008

  • Prosalud

    Santiago, 8380456

  • Clinical Research Chile SpA

    Valdivia, 5110683

Other trials in Chile

Spain5 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Regional de Málaga

    Málaga, MALAGA, 29009

  • Hospital Quirónsalud Infanta Luisa

    Seville, SEVILLA, 41010

  • Hospital Universitario Doctor Peset

    Valencia, 46017

Other trials in Spain

Bulgaria4 sites

  • Multiprofile Hospital For Active Treatment Trimontium

    Plovdiv, Plodiv, 4002

  • University Multiprofile Hospital for Active Treatment Pulmed

    Plovdiv, 4002

  • Diagnostic and Consulting Center "Aleksandrovska" EOOD

    Sofia, 1431

  • Diagnostic Consulting Center Fokus-5

    Sofia, 1463

Other trials in Bulgaria

Israel4 sites

  • Rambam Healthcare Campus

    Haifa, 3109601

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Galilee Medical Center

    Nahariya, 2210001

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Romania4 sites

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

    Brasov, 500283

  • SC Sana Monitoring SRL

    Bucharest, 11025

  • Spitalul Clinic "Sf. Maria"

    Bucharest, 11172

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, 400006

Other trials in Romania

France2 sites

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

    Brest, Brittany Region, 29609

  • Hôpital Haut-Lévêque

    Pessac, 33604

Other trials in France

Taiwan2 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

Other trials in Taiwan

Thailand2 sites

  • Rajavithi Hospital

    Bangkok, 10400

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Turkey (Türkiye)2 sites

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34098

  • Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

    Konya, 42080

Other trials in Turkey (Türkiye)

United Kingdom2 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

Czechia1 site

  • CCR Pardubice

    Pardubice, Vychodocesky KRAJ, 530 02

Other trials in Czechia

Germany1 site

  • Städtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

Other trials in Germany

Greece1 site

  • General Hospital of Athens "Laiko"

    Goudi, 11527

Other trials in Greece

Hungary1 site

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet

    Budapest, Budapest, 1097

Other trials in Hungary

Japan1 site

  • Tomakomai City Hospital

    Tomakomai-shi, 053-0034

Other trials in Japan

Puerto Rico1 site

  • Centro Reumatologico de Caguas

    Caguas, 00725

Other trials in Puerto Rico

About this study

Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

Read the detailed description

This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Being tested
Cenerimod 0.5 mg, Cenerimod 1 mg, Cenerimod 2 mg, Cenerimod 4 mg, Placebo
Keywords
Musculoskeletal and connective tissue disorders
Medical subject headings
Lupus Erythematosus, Systemic, Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cenerimod 0.5 mgDrug

    Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg

  • Cenerimod 1 mgDrug

    Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg

  • Cenerimod 2 mgDrug

    Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg

  • Cenerimod 4 mgDrug

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

  • PlaceboDrug

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

  • cenerimod 2 mg (ex-4 mg)Drug

    Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg

Study groups in NCT03742037
Study groupRoleWhat they receive
Cenerimod 0.5 mgExperimentalParticipants will receive cenerimod 0.5 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 0.5 mg for a further 6 months and end study treatment at the Month 12 visit.
Receives: Drug: Cenerimod 0.5 mg
Cenerimod 1 mgExperimentalParticipants will receive cenerimod 1 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 1 mg for a further 6 months and end study treatment at the Month 12 visit.
Receives: Drug: Cenerimod 1 mg
Cenerimod 2 mgExperimentalParticipants will receive cenerimod 2 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 2 mg for a further 6 months and end study treatment at the Month 12 visit.
Receives: Drug: Cenerimod 2 mg
Cenerimod 2 mg (Ex-4mg)ExperimentalHalf the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
Receives: Drug: cenerimod 2 mg (ex-4 mg)
Placebo (Ex-4mg)Placebo comparatorHalf the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to placebo (matching cenerimod) once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
Receives: Drug: Placebo
Cenerimod 4 mgExperimentalParticipants will received cenerimod 4 mg once daily in addition to background SLE therapy for up to 6 months in Treatment Period 1. The participants randomized to the 4 mg treatment who were still on treatment at Month 6 were re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2. The participants who did not complete 6 months of cenerimod 4 mg treatment will be analyzed in the "Non Re-randomized (Ex-4mg)" treatment group.
Receives: Drug: Cenerimod 4 mg
PlaceboPlacebo comparatorParticipants will receive placebo (matching cenerimod) once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with placebo (matching cenerimod) for a further 6 months and end study treatment at the Month 12 visit.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score

    The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days. 0 points indicates inactive disease, and 105 points is the maximum possible score. In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.

    Measured: Baseline (Day 1) and Month 6

Secondary outcomes (2)

  1. Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline

    A responder could only be assessed if the full information of all body systems was available. A participant was defined as a responder based on the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) was a composite, binary endpoint based on three variables:

    • mSLEDAI-2K score had to have a reduction from baseline greater than or equal to 4,
    • Physician Global Assessment (PGA) had to have an increase from baseline less than or equal to 0.3. The PGA is a 100 mm visual analog scale used by the physician to assess disease activity ranging for 0 to 3. The scale is anchored with values from 0 = "none" and 3 = "severe"), and
    • BILAG-2004 (no new BILAG A organ domain score and at most one new BILAG B organ domain score) compared with baseline.

    If one of the SRI-4 mSLEDAI-2K, PGA and BILAG variables were not met the subject was scored a non-responder. Participants that did not fit at least one of the above criteria were assigned to the missing group.

    Measured: Baseline (Day 1) and Month 6

  2. British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6

    The British Isles Lupus Assessment Group-2004 (BILAG) is a comprehensive tool used by the physician to assess disease activity and is sensitive to small changes over time.

    Response (no worsening) at Month 6 on BILAG-2004 disease activity index was defined as no new BILAG A organ domain score and no more than one new BILAG B organ domain score compared with baseline.

    No analysis is reported because the model did not meet the convergence criteria.

    Measured: Baseline (Day 1) and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start21 Dec 2018
  3. Primary completion31 Aug 2021
  4. Study completion25 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants randomized to the 4 mg arm who are still on treatment at month 6 will be re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2 and will continue study treatment for a total maximum of 12 months.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742037
Sponsor's protocol ID
ID-064A202
Other IDs
2018-001808-11, 2018
Status last verified
Sep 2023
First submitted
12 Nov 2018
Last updated
29 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Suffiotti M, Brazauskas P, Keller MP, Berkani O, Seifer G, Cornelisse P, Murphy MJ, Strasser DS. Pharmacodynamics of the S1P1 receptor modulator cenerimod in a phase 2b randomised clinical trial in patients with moderate to severe SLE. Ann Rheum Dis. 2025 Feb;84(2):284-293. doi: 10.1136/ard-2024-226547. Epub 2025 Jan 16.

    PubMed 39919901

  • 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.

    PubMed 39586304

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cenerimod 0.5 mg, Cenerimod 1 mg and Cenerimod 2 mg in people with Systemic Lupus Erythematosus, run by Viatris Innovation GmbH at 148 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Mexico, Ukraine, Russia, Georgia and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score (time frame: Baseline (Day 1) and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742037, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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