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

NCT03742037 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: ID-064A2022018-001808-11
• Study Type: interventional
• Target: 427
• Locations: 24 countries
• Sites: 148

Brief 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).

Conditions

Systemic Lupus Erythematosus

Keywords

Musculoskeletal and connective tissue disorders

Outcome Measures

Primary Outcomes (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.

  Baseline (Day 1) and Month 6

Secondary Outcomes (2)

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

  Baseline (Day 1) and Month 6

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

  Baseline (Day 1) and Month 6

Study Arms (7)

Cenerimod 0.5 mg

EXPERIMENTAL

Participants 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.

Drug: Cenerimod 0.5 mg

Cenerimod 1 mg

EXPERIMENTAL

Participants 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.

Drug: Cenerimod 1 mg

Cenerimod 2 mg

EXPERIMENTAL

Participants 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.

Drug: Cenerimod 2 mg

Cenerimod 2 mg (Ex-4mg)

EXPERIMENTAL

Half 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.

Drug: cenerimod 2 mg (ex-4 mg)

Placebo (Ex-4mg)

PLACEBO COMPARATOR

Half 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.

Drug: Placebo

Cenerimod 4 mg

EXPERIMENTAL

Participants 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.

Drug: Cenerimod 4 mg

Placebo

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo

Interventions

Cenerimod 0.5 mg DRUG

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

Cenerimod 0.5 mg

Cenerimod 1 mg DRUG

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

Cenerimod 1 mg

Cenerimod 2 mg DRUG

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

Cenerimod 2 mg

Cenerimod 4 mg DRUG

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

Cenerimod 4 mg

Placebo DRUG

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

Placebo; Placebo (Ex-4mg)

cenerimod 2 mg (ex-4 mg) DRUG

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

Cenerimod 2 mg (Ex-4mg)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (148)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

University of California San Diego

La Jolla, California, 92037-0493, United States

Location

Valerius Medical Group and Research Center

Los Alamitos, California, 90720-5403, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Robert W Levin MD PA

Clearwater, Florida, 33765, United States

Location

Center for Rheumatology Immunology and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

Life Clinical Trials

Margate, Florida, 33063, United States

Location

D&H National Research Centers INC

Miami, Florida, 33155, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 33014, United States

Location

Millennium Research

Ormond Beach, Florida, 32174-1139, United States

Location

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

Location

Advanced Research Institute Inc Allergy & Rheumatology

St. Petersburg, Florida, 33708, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33603, United States

Location

North Georgia Rheumatology Group - Duluth

Lawrenceville, Georgia, 30046, United States

Location

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Innovative Health Research

Las Vegas, Nevada, 89128, United States

Location

New York Presbyterian Columbia University Medical Center

New York, New York, 10032, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Joint Muscle Medical Care and Research Institute - Lilington Office

Charlotte, North Carolina, 28204, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

Paramount Medical Research and Consulting

Middleburg Heights, Ohio, 44130, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Office of Ramesh C. Gupta, MD

Memphis, Tennessee, 38119, United States

Location

Amarillo Center for Clinical Research

Amarillo, Texas, 79124, United States

Location

Accurate Clinical Research

Houston, Texas, 77034, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Accurate Clinical Management

Stafford, Texas, 77477, United States

Location

Multiprofile Hospital For Active Treatment Trimontium

Plovdiv, Plodiv, 4002, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Pulmed

Plovdiv, 4002, Bulgaria

Location

Diagnostic and Consulting Center "Aleksandrovska" EOOD

Sofia, 1431, Bulgaria

Location

Diagnostic Consulting Center Fokus-5

Sofia, 1463, Bulgaria

Location

Enroll SpA

Santiago, 7500588, Chile

Location

Biomedica Research Group

Santiago, 7500710, Chile

Location

Meditek Ltda.

Santiago, 8330008, Chile

Location

Prosalud

Santiago, 8380456, Chile

Location

Clinical Research Chile SpA

Valdivia, 5110683, Chile

Location

CCR Pardubice

Pardubice, Vychodocesky KRAJ, 530 02, Czechia

Location

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

Brest, Brittany Region, 29609, France

Location

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

LTD "New Plasma Clinic"

Batumi, 6010, Georgia

Location

Aversi Clinic LTD

Tbilisi, 0160, Georgia

Location

Medi Club Georgia Ltd.

Tbilisi, 0160, Georgia

Location

Ltd. Mtskheta Street Clinic

Tbilisi, 0179, Georgia

Location

The First Medical Center Ltd.

Tbilisi, 0180, Georgia

Location

LLC "Innova"

Tbilisi, 0186, Georgia

Location

LLC Raymann

Tbilisi, 0186, Georgia

Location

LTD "Tbilisi Heart Center"

Tbilisi, 0186, Georgia

Location

Medicore

Tbilisi, 0186, Georgia

Location

Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

General Hospital of Athens "Laiko"

Goudi, 11527, Greece

Location

Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet

Budapest, 1097, Hungary

Location

Rambam Healthcare Campus

Haifa, 3109601, Israel

Location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location

Galilee Medical Center

Nahariya, 2210001, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

LUPUS CLINIC c/o DIMI

Genova, 16132, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, 00158, Italy

Location

Fondazione Policlinico Universitario A. Gemelli

Roma, 00168, Italy

Location

A.O. Mauriziano Umberto I di Torino

Torino, 10128, Italy

Location

Tomakomai City Hospital

Tomakomai-shi, 053-0034, Japan

Location

Consultorio Particular Dr. Miguel Cortés Hernández

Cuernavaca, 62448, Mexico

Location

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

Guadalajara, 44160, Mexico

Location

Icle S.C.

Guadalajara, 44600, Mexico

Location

Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá

Guadalajara, 44650, Mexico

Location

Consultorio Médico del Dr. Federico Galván Villegas

Guadalajara, 45040, Mexico

Location

Morales Vargas Centro de Investigación S.C.

León, 37000, Mexico

Location

Karla Adriana Espinosa Bautista

Mexico City, 01120, Mexico

Location

Centro de Investigación Clínica GRAMEL, S.C.

Mexico City, 03720, Mexico

Location

Biológicos Especializados S.A. de C.V.

Mexico City, 6700, Mexico

Location

Unidad de Atención Médica e Investigación en Salud

Mérida, 97000, Mexico

Location

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

Mérida, 97070, Mexico

Location

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

Monterrey, 64000, Mexico

Location

UBAM Unidad Biomédica Avanzada Monterrey

Monterrey, 64460, Mexico

Location

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

Querétaro, 76070, Mexico

Location

Hospital Universitario "Dr. Gonzalo Valdés Valdés"

Saltillo, 25000, Mexico

Location

Unidad de Investigaciones Reumatológicas A.C.

San Luis Potosí City, 78290, Mexico

Location

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

San Luis Potosí City, Mexico

Location

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

Zapopan, 45030, Mexico

Location

Lipa Medix Medical Center

Lipa City, Batangas, 4217, Philippines

Location

Angeles University Foundation Medical Center

Angeles City, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

Iloilo Doctors Hospital

Iloilo City, 5000, Philippines

Location

Makati Medical Center

Makati City, 1229, Philippines

Location

University of the Philippines Manila - Philippine General Hospital

Manila, 1000, Philippines

Location

Jose R. Reyes Memorial Medical Center

Manila, 1003, Philippines

Location

University of Santo Tomas Hospital

Manila, 1015, Philippines

Location

St. Luke's Medical Center

Quezon City, 1102, Philippines

Location

Far Eastern University - Nicanor Reyes Medical Foundation

Quezon City, 1118, Philippines

Location

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

Bydgoszcz, 85-168, Poland

Location

Intermedius Uslugi Medyczne

Kościan, 64-000, Poland

Location

Szpital Specjalistyczny im. J. Dietla w Krakowie

Krakow, 30-121, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Twoja Przychodnia Poznańskie Centrum Medyczne

Poznan, 61-293, Poland

Location

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

Ustroń, 43-450, Poland

Location

Centro Reumatologico de Caguas

Caguas, 00725, Puerto Rico

Location

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

Brasov, 500283, Romania

Location

SC Sana Monitoring SRL

Bucharest, 11025, Romania

Location

Spitalul Clinic "Sf. Maria"

Bucharest, 11172, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, 400006, Romania

Location

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, 454076, Russia

Location

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

Moscow, 111539, Russia

Location

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

Moscow, 115522, Russia

Location

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

Moscow, 125315, Russia

Location

Medical Center "Zdorovaya Semiya", LLC

Novosibirsk, 630099, Russia

Location

Orenburg State Medical University

Orenburg, 460018, Russia

Location

Clinical Rheumatological Hospital Number 25

Saint Petersburg, 190068, Russia

Location

Military Medical Academy S.M. Kirov

Saint Petersburg, 191045, Russia

Location

Polyclinic of Private Security and Detectives

Saint Petersburg, 192007, Russia

Location

Medical Research Institute, LLC

Saint Petersburg, 196006, Russia

Location

Medical Center Maksimum Zdorovia

Saint Petersburg, 650066, Russia

Location

Saratov Regional Clinical Hospital

Saratov, 410053, Russia

Location

State Institution of Health Protection "Clinical Hospital #8"

Yaroslavl, 150030, Russia

Location

JSC "Center of Family Medicine"

Yekaterinburg, 620043, Russia

Location

Hospital Universitario Regional de Málaga

Málaga, Malaga, 29009, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Quirónsalud Infanta Luisa

Seville, 41010, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Kaohsiung Medical University Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

Konya, 42080, Turkey (Türkiye)

Location

Kyiv City Clinical Hospital №3

Kyiv, 02125, Ukraine

Location

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

Kyiv, 03151, Ukraine

Location

Medical Centre "Consilium medical"

Kyiv, 04050, Ukraine

Location

Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"

Kyiv, 04107, Ukraine

Location

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

Lviv, 79000, Ukraine

Location

Municipal Nonprofit Institution of Lviv Regional Council

Lviv, 79000, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

Poltava Regional Clinical Hospital named after M.V. Sklifossovsky

Poltava, 36011, Ukraine

Location

Ternopil University Clinic - Rheumatology department

Ternopil, 46001, Ukraine

Location

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

Uzhhorod, 88000, Ukraine

Location

Private Small Scale Medical Center "Pulse"

Vinnytsia, 21001, Ukraine

Location

Medical Center "Health Clinic", LLC

Vinnytsia, 21009, Ukraine

Location

Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"

Vinnytsia, 21018, Ukraine

Location

Vinnytsya Regional Clinical Hospital - Rheumatology Department

Vinnytsia, 21018, Ukraine

Location

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

Vinnytsia, 21029, Ukraine

Location

Municipal Institution "Zaporizhzhya Regional Clinical Hospital"

Zaporizhzhya, 69600, Ukraine

Location

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

Zhytomyr, 10002, Ukraine

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Guy's and Saint Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39919901 DERIVED

• 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.

  PMID: 39586304 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Connective Tissue Diseases

Interventions

cenerimod

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Viatris Innovation Clinical Trial Information
• Organization: Viatris Innovation GmbH

viatrisinnovationclinicaltrials@viatris.com

+1 908 435 2675

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: December 21, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 25, 2022
• Last Updated: October 3, 2025
• Results First Posted: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2); US (29); FR (2); GR (1); HU (1); ES (5); PH (10); CL (5); DE (1); PR (1); IL (4); CZ (1); TW (2); PL (6); IT (6); RU (14); TH (2); JP (1); UA (17); RO (4); GB (2); ME (18); GE (10); BU (4)