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

PHASE2CompletedINTERVENTIONAL
Enrollment

427

Participants

Timeline

Start Date

December 21, 2018

Primary Completion Date

August 31, 2021

Study Completion Date

August 25, 2022

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Cenerimod 0.5 mg

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

DRUG

Cenerimod 1 mg

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

DRUG

Cenerimod 2 mg

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

DRUG

Cenerimod 4 mg

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

DRUG

Placebo

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

DRUG

cenerimod 2 mg (ex-4 mg)

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

Trial Locations (148)

1000

University of the Philippines Manila - Philippine General Hospital, Manila

1003

Jose R. Reyes Memorial Medical Center, Manila

1015

University of Santo Tomas Hospital, Manila

1097

Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet, Budapest

1102

St. Luke's Medical Center, Quezon City

1118

Far Eastern University - Nicanor Reyes Medical Foundation, Quezon City

1229

Makati Medical Center, Makati City

1431

"Diagnostic and Consulting Center Aleksandrovska EOOD", Sofia

1463

Diagnostic Consulting Center Fokus-5, Sofia

4002

Multiprofile Hospital For Active Treatment Trimontium, Plovdiv

University Multiprofile Hospital for Active Treatment Pulmed, Plovdiv

4217

Lipa Medix Medical Center, Lipa City

5000

Iloilo Doctors Hospital, Iloilo City

6010

"LTD New Plasma Clinic", Batumi

6700

Biológicos Especializados S.A. de C.V., Mexico City

8000

Davao Doctors Hospital, Davao City

10002

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

10032

New York Presbyterian Columbia University Medical Center, New York

10128

A.O. Mauriziano Umberto I di Torino, Torino

10400

Rajavithi Hospital, Bangkok

11025

SC Sana Monitoring SRL, Bucharest

11172

"Spitalul Clinic Sf. Maria", Bucharest

11527

"General Hospital of Athens Laiko", Goudi

13210

State University of New York Upstate Medical University, Syracuse

16132

LUPUS CLINIC c/o DIMI, Genova

16635

Altoona Center for Clinical Research, Duncansville

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20132

Ospedale San Raffaele, Milan

21001

"Private Small Scale Medical Center Pulse", Vinnytsia

21009

"Medical Center Health Clinic, LLC", Vinnytsia

21018

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

Vinnytsya Regional Clinical Hospital - Rheumatology Department, Vinnytsia

21029

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

25000

"Hospital Universitario Dr. Gonzalo Valdés Valdés", Saltillo

28041

Hospital Universitario 12 de Octubre, Madrid

28204

Joint Muscle Medical Care and Research Institute - Lilington Office, Charlotte

28210

DJL Clinical Research, Charlotte

29009

Hospital Universitario Regional de Málaga, Málaga

29609

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

30046

North Georgia Rheumatology Group - Duluth, Lawrenceville

33014

San Marcus Research Clinic, Miami Lakes

33063

Life Clinical Trials, Margate

33155

D&H National Research Centers INC, Miami

33309

Center for Rheumatology Immunology and Arthritis, Fort Lauderdale

33324

Integral Rheumatology & Immunology Specialists, Plantation

33603

Axiom Clinical Research of Florida, Tampa

33604

Hôpital Haut-Lévêque, Pessac

33708

Advanced Research Institute Inc Allergy & Rheumatology, St. Petersburg

33765

Robert W Levin MD PA, Clearwater

34098

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

36011

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

36207

Pinnacle Research Group, Anniston

37000

Morales Vargas Centro de Investigación S.C., León

38119

Office of Ramesh C. Gupta, MD, Memphis

41010

Hospital Quirónsalud Infanta Luisa, Seville

42080

Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi, Konya

44130

Paramount Medical Research and Consulting, Middleburg Heights

44160

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

44600

Icle S.C., Guadalajara

44650

Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá, Guadalajara

45030

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

45040

Consultorio Médico del Dr. Federico Galván Villegas, Guadalajara

46001

Ternopil University Clinic - Rheumatology department, Ternopil

46017

Hospital Universitario Doctor Peset, Valencia

62448

Consultorio Particular Dr. Miguel Cortés Hernández, Cuernavaca

63110

Washington University School of Medicine, St Louis

64000

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

64460

UBAM Unidad Biomédica Avanzada Monterrey, Monterrey

69600

"Municipal Institution Zaporizhzhya Regional Clinical Hospital", Zaporizhzhya

75150

Southwest Rheumatology Research, LLC, Mesquite

76070

SMIQ, S. de R.L. de C.V., Querétaro

76133

Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe

77034

Accurate Clinical Research, Houston

77477

Accurate Clinical Management, Stafford

78215

Sun Research Institute, San Antonio

78290

Unidad de Investigaciones Reumatológicas A.C., San Luis Potosí City

79000

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

Municipal Nonprofit Institution of Lviv Regional Council, Lviv

79010

Lviv Regional Clinical Hospital, Lviv

79124

Amarillo Center for Clinical Research, Amarillo

80045

University of Colorado School of Medicine, Aurora

80756

Kaohsiung Medical University Hospital, Kaohsiung City

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

83404

Institute of Arthritis Research, Idaho Falls

88000

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

89128

Innovative Health Research, Las Vegas

90110

Songklanagarind Hospital, Songkhla

97000

Unidad de Atención Médica e Investigación en Salud, Mérida

97070

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

111539

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

115522

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

125315

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

150030

"State Institution of Health Protection Clinical Hospital #8", Yaroslavl

190068

Clinical Rheumatological Hospital Number 25, Saint Petersburg

191045

Military Medical Academy S.M. Kirov, Saint Petersburg

192007

Polyclinic of Private Security and Detectives, Saint Petersburg

196006

Medical Research Institute, LLC, Saint Petersburg

400006

Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Cluj-Napoca

410053

Saratov Regional Clinical Hospital, Saratov

454076

Chelyabinsk Regional Clinical Hospital, Chelyabinsk

460018

Orenburg State Medical University, Orenburg

500283

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed, Brasov

620043

"JSC Center of Family Medicine", Yekaterinburg

630099

"Medical Center Zdorovaya Semiya, LLC", Novosibirsk

650066

Medical Center Maksimum Zdorovia, Saint Petersburg

2210001

Galilee Medical Center, Nahariya

3109601

Rambam Healthcare Campus, Haifa

3339419

Bnai Zion Medical Center, Haifa

5110683

Clinical Research Chile SpA, Valdivia

5265601

The Chaim Sheba Medical Center, Ramat Gan

7500588

Enroll SpA, Santiago

7500710

Biomedica Research Group, Santiago

8330008

Meditek Ltda., Santiago

8380456

Prosalud, Santiago

92037-0493

University of California San Diego, La Jolla

90720-5403

Valerius Medical Group and Research Center, Los Alamitos

32174-1139

Millennium Research, Ormond Beach

530 02

CCR Pardubice, Pardubice

0160

Aversi Clinic LTD, Tbilisi

Medi Club Georgia Ltd., Tbilisi

0179

Ltd. Mtskheta Street Clinic, Tbilisi

0180

The First Medical Center Ltd., Tbilisi

0186

"LLC Innova", Tbilisi

LLC Raymann, Tbilisi

"LTD Tbilisi Heart Center", Tbilisi

Medicore, Tbilisi

Multiprofile Clinic Consilium Medulla, Tbilisi

00158

Azienda Ospedaliera San Camillo Forlanini, Roma

00168

Fondazione Policlinico Universitario A. Gemelli, Roma

053-0034

Tomakomai City Hospital, Tomakomai-shi

01120

Karla Adriana Espinosa Bautista, Mexico City

03720

Centro de Investigación Clínica GRAMEL, S.C., Mexico City

Unknown

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

Angeles University Foundation Medical Center, Angeles City

85-168

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

64-000

Intermedius Uslugi Medyczne, Kościan

30-121

Szpital Specjalistyczny im. J. Dietla w Krakowie, Krakow

30-363

Centrum Medyczne Plejady, Krakow

61-293

Twoja Przychodnia Poznańskie Centrum Medyczne, Poznan

43-450

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

00725

Centro Reumatologico de Caguas, Caguas

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

02125

Kyiv City Clinical Hospital №3, Kyiv

03151

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

04050

"Medical Centre Consilium medical", Kyiv

04107

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

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

SE1 9RT

Guy's and Saint Thomas' NHS Foundation Trust, London

All Listed Sponsors
lead

Viatris Innovation GmbH

INDUSTRY

NCT03742037 - Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter