AzTrials
AzTrials

Lupus Erythematosus, SystemicPhase 3OPUS-2NCT05672576

A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

A Phase 3 study testing Cenerimod in people with Lupus Erythematosus, Systemic, run by Viatris Innovation GmbH at 147 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Cenerimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
451 participants
Where
147 sitesin 18 countries
Study dates
26 Jun 2023to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 (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:
Show all 79Show fewer
  • 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.
  • Main 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 antiarrhythmic 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.

Who cannot join

None listed.

Trial locations and contacts

147 sites in 18 countries.

147 sites in 18 countries

United States17 sites

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Hope Clinical Trials, Inc.

    Coral Gables, Florida, 33134

  • Texas Arthritis Center

    El Paso, Texas, 79902

  • Vital Pharma Research

    Hialeah, Florida, 33016

  • Tectum Medical Research

    Hollywood, Florida, 33024

  • Northwest Houston Arthritis Center

    Houston, Texas, 77090

  • Alloy Clinical Research, LLC

    Kissimmee, Florida, 34741

  • UCSD Perlman Medical Offices

    La Jolla, California, 92037-0943

  • RB Wellness Clinic

    Las Vegas, Nevada, 89102

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • D&H National Research Centers INC

    Miami, Florida, 33155

  • Professional research Center INC

    Miami, Florida, 33172

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Columbia University Medical Center

    New York, New York, 10032

  • Amicis Research Center

    Northridge, California, 91234

  • Tucson Clinical Research Institute, LLC

    Tucson, Arizona, 85712

Other trials in United States

Georgia15 sites

  • LTD "New Plasma Clinic"

    Batumi, 6010

  • Institute of Clinical Cardiology, Ltd

    Tbilisi, 0159

  • LTD "Tbilisi Central Hospital"

    Tbilisi, 0159

  • National Institute of Endocrinology Ltd.

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic Ltd.

    Tbilisi, 0159

  • Aversi Clinic LTD

    Tbilisi, 0160

  • Medi Club Georgia Ltd.

    Tbilisi, 0160

  • Tbilisi Institute of Medicine

    Tbilisi, 0160

  • JSC Jerarsi Clinic

    Tbilisi, 0167

  • Ltd. Mtskheta Street Clinic

    Tbilisi, 0179

  • The First Medical Center Ltd.

    Tbilisi, 0180

  • Caucasus Medical Centre

    Tbilisi, 0186

  • LLC "Innova"

    Tbilisi, 0186

  • LLC Raymann

    Tbilisi, 0186

  • LTD "Tbilisi Heart Center"

    Tbilisi, 0186

Other trials in Georgia

Mexico13 sites

  • Consultorio Particular Dr. Miguel Cortés Hernández

    Cuernavaca, 62448

  • Centro Integral en Reumatologia SA de CV (CIRSA)

    Guadalajara, 44160

  • Morales Vargas Centro de Investigación S.C.

    León, 37000

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P. (CEMDEICY S.C.P.)

    Mérida, 97130

  • Boca Clinical Trials Mexico, S.C.

    Mexico City, 01120

  • Centro de Investigación Clínica GRAMEL, S.C.

    Mexico City, 03720

  • Clinstile, S.A. de C.V.

    Mexico City, 06700

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000

  • UBAM Unidad Biomédica Avanzada Monterrey

    Monterrey, 64460

  • Oaxaca contra el Cáncer A.C

    Oaxaca City, 68000

  • Centro de Estudios Clínicos de Querétaro S.C.

    Querétaro, 76000

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

  • PCR Toluca - Phylasis Clinical Research

    Toluca, 50090

Other trials in Mexico

Peru13 sites

  • Unidad de Investigación en Medicina Interna y Enfermedades Críticas / Hogar Clínica San Juan de Dios

    Cayma, 04017

  • Centro de Investigacion Clinica Inmunoreumatologia / ACQ Medic SAC

    Jesús María, 15076

  • Centro de Investigación del Hospital Militar Central

    Jesús María, 15076

  • Alberto Sabogal Sologuren National Hospital

    Lima, 07011

  • Hospital Maria Auxiliadora

    Lima, 15828

  • Unidad de Investigación de la Clinica International

    San Borja, 15036

  • Instituto Peruano del Hueso y la Articulación S.A.C. (IPHAR)

    San Isidro, 15046

  • Clínica Anglo Americana

    San Isidro, 15073

  • Servicios Reumatológicos SOMA E.I.R.L. / Clinica El Golf

    San Isidro, 15076

  • Unidad de Investigación en Reumatología e Inmunología CSJB

    San Juan de Lurigancho, 15431

  • Hospital Nacional Cayetano Heredia

    San Martín de Porres, 15102

  • Investigaciones Clinicas / Instituto de Ginecología y Reproducción, El Derby

    Santiago de Surco, 15023

  • Centro de Investigación Clínica Trujillo EIRL / Clínica Peruano Americana S.A

    Trujillo, 13011

Other trials in Peru

Spain12 sites

  • Accellacare

    Alcobendas, 28100

  • Parc Tauli Sabadell University Hospital

    Barcelona, 08208

  • Hospital Universitari Vall d'Hebron

    Colmenar Viejo, 08035

  • Hospital Universitario Ramon y Cajal

    Colmenar Viejo, 28770

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Clinica Gaias Santiago

    Santiago de Compostela, 15702

  • Hospital QuironSalud Sagrado Corazon

    Seville, 41013

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Doctor Peset

    Valencia, 46017

  • Hospital Universitario Río Hortega de Valladolid

    Valladolid, 47012

Other trials in Spain

Ukraine12 sites

  • Communal Non-profit Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council, Rheumatology Department

    Chernihiv, 14029

  • St. Luke's Treatment and Diagnostic Center

    Ivano-Frankivsk, 76019

  • Medical Center "Harmoniia krasy", LLC

    Kyiv, 01135

  • Medical Center of the Limited Liability Company "Edelweiss Medics", Treatment and Prevention Department

    Kyiv, 02002

  • Med Center "Ok!Clinic+" of Ltd Liability Com "Inter Ins of Clin Rsrch", Inpatient dprt, Unit of Ther, Rheuma and Cardio

    Kyiv, 02091

  • "Medbud-Clinic" LLC, Treatment and Prevention Department of the Medical Center

    Kyiv, 03037

  • Medical Center "Universal Clinic "Oberih"" of Limited Liability Company "Capital"

    Kyiv, 03057

  • Limited Liability Company "Medical Centre 'Consilium Medical'", Clinical and Consultation Department

    Kyiv, 04050

  • Medical Center "Center of Family Medicine Plus" LLC, Treatment and Prevention Department

    Kyiv, 04210

  • Ternopil Regional Clinical Hospital

    Ternopil, 46002

  • "Medical Center Health Clinic" LLC, Medical Clinical Investigational Center, Department of Cardiology and Rheumatology

    Vinnytsia, 21009

  • Communal Non-Com Entr Vinnytsia City Clin Hpt 1, Clin Therapy Dprt 2, Vinnytsia Nat Pirogov Memo Med Uni, Dprt of Internal Med 3

    Vinnytsia, 21029

Other trials in Ukraine

India10 sites

  • Shalby Hospitals

    Ahmedabad, 380015

  • Chennai Meenakshi Multispeciality Hospital Pvt. Ltd.

    Chennai, 600004

  • ESIC Medical College and Hospital

    Hyderabad, 500038

  • IPGME&R and SSKM Hospital

    Kolkata, 700020

  • Jasleen Hospital

    Nagpur, 440012

  • Chopda Medicare & Research Centre

    Nashik, 422005

  • AIIMS New Delhi

    New Delhi, 110029

  • Center for Rheumatic Diseases

    Pune, 411001

  • Yashoda Hospital

    Secunderabad, 500003

  • Nirmal Hospital Private Limited

    Surat, 395002

Other trials in India

Serbia8 sites

  • Institute of Rheumatology, Belgrade (study site 1)

    Belgrade, 11000

  • Institute of Rheumatology, Belgrade (study site 2)

    Belgrade, 11000

  • Institute of Rheumatology, Belgrade (study site 3)

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11040

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Special Hospital for Rheumatic Diseases, Novi Sad

    Novi Sad, 21000

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Chile7 sites

  • Biomedica Research Group

    Providencia, 7500710

  • Sociedad Médica del Aparato Locomotor S. A.

    Providencia, 7510186

  • Estudios G y C Ltda

    Santiago, 7500504

  • Enroll SpA

    Santiago, 7500587

  • Centro de Especialidades Medicas Vanguardia

    Temuco, 4810345

  • Clinical Research Chile SpA

    Valdivia, 5110683

  • Hospital San José de Victoria

    Victoria, 4720001

Other trials in Chile

Portugal7 sites

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2720-276

  • Centro Hospitalar Universitário do Algarve - Hospital de Faro

    Faro, 8000-386

  • ULS Guarda

    Guarda, 6300-749

  • Hospital Senhora Oliveira-Guimaraes

    Guimarães, 4835-044

  • Instituto Portugues De Reumatologia

    Lisbon, 1050-034

  • Unidade Local De Saude Lisboa Ocidental E.P.E.

    Lisbon, 1349-019

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Malaysia6 sites

  • Hospital Selayang

    Batu Caves, 68100

  • Universiti Kebangsaan Malaysia - Medical Centre

    Cheras, 56000

  • Hospital Tuanku Fauziah, Kangar

    Kangar, 01000

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Sarawak General Hospital

    Kuching, 93586

  • Hospital Sibu, Sarawak

    Sibu, 96000

Other trials in Malaysia

Philippines6 sites

  • Iloilo Doctors Hospital

    Iloilo City, 5000

  • Makati Medical Center

    Makati, 1229

  • Ospital ng Makati

    Makati City, 1218

  • St Lukes Medical Center

    Manila, 1102

  • The Medical City Clark

    Pampanga, 2023

  • St Luke's Medical Center Quezon City / University of Santo Tomas Hospital

    Sampaloc, 1015

Other trials in Philippines

Poland6 sites

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

    Bydgoszcz, 85-168

  • Santa Sp. z o.o.

    Lodz, 90-302

  • Medyczne Centrum Hetmańska

    Poznan, 60-218

  • Twoja Przychodnia Poznańskie Centrum Medyczne

    Poznan, 61-293

  • Pomorski Uniwersytet Medyczny w Szczecinie

    Szczecin, 71-252

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

Other trials in Poland

South Africa5 sites

  • Arthritis Clinical Research Trials

    Cape Town, 7405

  • Panorama Medical Centre

    Cape Town, 7500

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, 2193

  • University of Pretoria

    Pretoria, 0002

  • Winelands Medical Research

    Somerset West, 7130

Other trials in South Africa

Germany4 sites

  • Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP

    Frankfurt am Main, 60596

  • Universitätsklinikum Leipzig

    Leipzig, 4103

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Universitätsklinikum Münster (UKM)

    Münster, 48149

Other trials in Germany

Czechia2 sites

  • iMedica s.r.o.

    Brno, 60200

  • Institute of Rheumatology Prague

    Prague, 12800

Other trials in Czechia

Puerto Rico2 sites

  • Centro Reumatologico de Caguas

    Caguas, 00725

  • GCM Medical Group, PSC

    San Juan, 917

Other trials in Puerto Rico

United Kingdom2 sites

  • University Hospitals of Leicester Nhs Trust

    Leicester, LE5 4PW

  • Guy's and St. Thomas' NHS Foundation Trust - Guy's Hospital

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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.

Being tested
Cenerimod, Placebo
Keywords
Musculoskeletal and connective tissue disorders, Immune System Diseases, Autoimmune Diseases
Medical subject headings
Lupus Erythematosus, Systemic, Connective Tissue Diseases, Immune System Diseases, Autoimmune Diseases

What participants receive

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

  • CenerimodDrug

    Also called ACT-334441

    Cenerimod will be supplied as 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.

Study groups in NCT05672576
Study groupRoleWhat they receive
Cenerimod 4 mgExperimentalParticipants will receive cenerimod once daily in addition to background SLE therapy.
Receives: Drug: Cenerimod
PlaceboPlacebo comparatorParticipants will receive matching placebo once daily in addition to background SLE therapy.
Receives: Drug: Placebo

What is being measured

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

  1. Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline

    Response on SRI-4 is defined as:

    • Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K [SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K]), and
    • No new British Isles Lupus Assessment Group-2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and
    • No worsening from baseline in subjects' lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point Physician's Global Assessment visual analog scale (PGA VAS), and
    • No violation of specified medication rules detailed in the core protocol.

    Measured: At Month 12 compared to Day 1 (pre-dose baseline)

Secondary outcomes (4)

  1. Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline

    Response on BICLA is defined as:

    • Improvement from baseline in disease activity as measured by BILAG. Improvement is defined as a reduction of all baseline BILAG A to B/C/D and baseline BILAG B to C/D and no BILAG worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG A or ≥ 2 new BILAG B, and
    • No worsening from baseline in mSLEDAI-2K, where worsening is defined as an increase from baseline of > 0 points in mSLEDAI-2K, and
    • No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase of ≥ 0.30 points on a 3-point PGA VAS, and
    • No discontinuation of investigational product, and
    • No violation of specified medication rules detailed in the core protocol.

    Measured: At Month 12 compared to Day 1 (pre-dose baseline)

  2. Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response

    A response is defined as a reduction of at least 4 points from baseline.

    Measured: Day 1 (pre-dose baseline) to Month 12

  3. Steroid sparing effect in the subgroup of subjects with baseline OCS dose ≥ 10 mg/day prednisone or equivalent

    Response is defined as meeting all of the following:

    • Achieve an OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Month 9.
    • Maintain an OCS dose ≤ 7.5 mg/day prednisone or equivalent from Month 9 to Month 12.
    • No violation of pre-specified medication rules detailed in the core protocol.

    Measured: Day 1 (pre-dose baseline) to Month 12

  4. Response at Month 12 in Lupus Low Disease Activity State (LLDAS)

    Response is defined as:

    • mSLEDAI-2K ≤ 4 (with no activity in major organ systems, i.e., renal, central nervous system, cardiopulmonary, vasculitis and fever).
    • No new features of lupus disease activity compared with the previous assessment.
    • PGA ≤ 1.
    • Current prednisone-equivalent dosage ≤ 7.5 mg/day.
    • Well tolerated standard maintenance dosages of immunosuppressive drugs and approved biologics.

    Measured: Day 1 (pre-dose baseline) to Month 12

Timeline

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

  1. First posted5 Jan 2023
  2. Study start26 Jun 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672576
Sponsor's protocol ID
ID-064A302
Other IDs
2022-002815-47, 2024-515871-37-00
Acronym
OPUS-2
Status last verified
Sep 2026
First submitted
3 Jan 2023
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 3 study testing Cenerimod in people with Lupus Erythematosus, Systemic, run by Viatris Innovation GmbH at 147 sites in 18 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 79 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Georgia, Mexico, Peru, Spain and 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline (time frame: At Month 12 compared to Day 1 (pre-dose baseline)). 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 NCT05672576, which also lists 1 linked publication.

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 30 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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