New lupus pill shows promise in major trial
NCT ID NCT05672576
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 6 times
Summary
This Phase 3 study tests whether adding cenerimod to standard lupus treatments can better control moderate-to-severe lupus symptoms. About 451 adults will receive either cenerimod or a placebo for 12 months. The main goal is to see if more people improve on a lupus disease activity index.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cenerimod
- What this could lead to
- If successful, cenerimod could become a new treatment option to better control lupus symptoms and reduce disease flares.
- What could go wrong
- This is still an experimental drug. Even in Phase 3, it may not work better than placebo, and side effects are possible. Results are not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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451 people
The number who actually took part.
- Started
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Jun 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria at screening: * 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: * 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. Inclusion criteria at randomization: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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"Medbud-Clinic" LLC, Treatment and Prevention Department of the Medical Center
Kyiv, 03037, Ukraine
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"Medical Center Health Clinic" LLC, Medical Clinical Investigational Center, Department of Cardiology and Rheumatology
Vinnytsia, 21009, Ukraine
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AIIMS New Delhi
New Delhi, 110029, India
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Accelerium, S. de R.L. de C.V.
Monterrey, 64000, Mexico
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Accellacare
Alcobendas, 28100, Spain
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Alberto Sabogal Sologuren National Hospital
Lima, 07011, Peru
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Allied Biomedical Research Institute
Miami, Florida, 33155, United States
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Alloy Clinical Research, LLC
Kissimmee, Florida, 34741, United States
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Amicis Research Center
Northridge, California, 91234, United States
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Arthritis Clinical Research Trials
Cape Town, 7405, South Africa
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Aversi Clinic LTD
Tbilisi, 0160, Georgia
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Biomedica Research Group
Providencia, 7500710, Chile
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Boca Clinical Trials Mexico, S.C.
Mexico City, 01120, Mexico
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Caucasus Medical Centre
Tbilisi, 0186, Georgia
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Center for Rheumatic Diseases
Pune, 411001, India
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Centro Hospitalar Universitário do Algarve - Hospital de Faro
Faro, 8000-386, Portugal
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Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
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Centro Integral en Reumatologia SA de CV (CIRSA)
Guadalajara, 44160, Mexico
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Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P. (CEMDEICY S.C.P.)
Mérida, 97130, Mexico
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Centro Reumatologico de Caguas
Caguas, 00725, Puerto Rico
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Centro de Especialidades Medicas Vanguardia
Temuco, 4810345, Chile
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Centro de Estudios Clínicos de Querétaro S.C.
Querétaro, 76000, Mexico
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Centro de Investigacion Clinica Inmunoreumatologia / ACQ Medic SAC
Jesús María, 15076, Peru
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Centro de Investigación Clínica GRAMEL, S.C.
Mexico City, 03720, Mexico
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Centro de Investigación Clínica Trujillo EIRL / Clínica Peruano Americana S.A
Trujillo, 13011, Peru
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Centro de Investigación del Hospital Militar Central
Jesús María, 15076, Peru
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Charlotte Maxeke Johannesburg Academic Hospital
Parktown, 2193, South Africa
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Chennai Meenakshi Multispeciality Hospital Pvt. Ltd.
Chennai, 600004, India
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Chopda Medicare & Research Centre
Nashik, 422005, India
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Clinica Gaias Santiago
Santiago de Compostela, 15702, Spain
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Clinical Center Kragujevac
Kragujevac, 34000, Serbia
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Clinical Research Chile SpA
Valdivia, 5110683, Chile
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Clinical Research Institute S.C.
Tlalnepantla, 54055, Mexico
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Clinstile, S.A. de C.V.
Mexico City, 06700, Mexico
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Clínica Anglo Americana
San Isidro, 15073, Peru
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Columbia University Medical Center
New York, New York, 10032, United States
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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, Ukraine
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Communal Non-profit Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council, Rheumatology Department
Chernihiv, 14029, Ukraine
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Consultorio Particular Dr. Miguel Cortés Hernández
Cuernavaca, 62448, Mexico
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D&H National Research Centers INC
Miami, Florida, 33155, United States
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ESIC Medical College and Hospital
Hyderabad, 500038, India
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Enroll SpA
Santiago, 7500587, Chile
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Estudios G y C Ltda
Santiago, 7500504, Chile
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Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP
Frankfurt am Main, 60596, Germany
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GCM Medical Group, PSC
San Juan, 917, Puerto Rico
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General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
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Guy's and St. Thomas' NHS Foundation Trust - Guy's Hospital
London, SE1 9RT, United Kingdom
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Hope Clinical Trials, Inc.
Coral Gables, Florida, 33134, United States
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Clínico San Carlos
Madrid, 28040, Spain
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Hospital Maria Auxiliadora
Lima, 15828, Peru
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Hospital Nacional Cayetano Heredia
San Martín de Porres, 15102, Peru
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Hospital Prof. Doutor Fernando Fonseca
Amadora, 2720-276, Portugal
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Hospital QuironSalud Sagrado Corazon
Seville, 41013, Spain
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Hospital San José de Victoria
Victoria, 4720001, Chile
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Hospital Selayang
Batu Caves, 68100, Malaysia
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Hospital Senhora Oliveira-Guimaraes
Guimarães, 4835-044, Portugal
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Hospital Sibu, Sarawak
Sibu, 96000, Malaysia
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Hospital Tuanku Fauziah, Kangar
Kangar, 01000, Malaysia
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Hospital Universitari Vall d'Hebron
Colmenar Viejo, 08035, Spain
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Hospital Universitario Doctor Peset
Valencia, 46017, Spain
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Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
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Hospital Universitario Nuestra Señora de Valme
Seville, 41014, Spain
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Hospital Universitario Ramon y Cajal
Colmenar Viejo, 28770, Spain
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Hospital Universitario Río Hortega de Valladolid
Valladolid, 47012, Spain
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IPGME&R and SSKM Hospital
Kolkata, 700020, India
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Iloilo Doctors Hospital
Iloilo City, 5000, Philippines
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Institute of Clinical Cardiology, Ltd
Tbilisi, 0159, Georgia
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Institute of Rheumatology Prague
Prague, 12800, Czechia
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Institute of Rheumatology, Belgrade (study site 1)
Belgrade, 11000, Serbia
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Institute of Rheumatology, Belgrade (study site 2)
Belgrade, 11000, Serbia
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Institute of Rheumatology, Belgrade (study site 3)
Belgrade, 11000, Serbia
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Instituto Peruano del Hueso y la Articulación S.A.C. (IPHAR)
San Isidro, 15046, Peru
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Instituto Portugues De Reumatologia
Lisbon, 1050-034, Portugal
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Investigaciones Clinicas / Instituto de Ginecología y Reproducción, El Derby
Santiago de Surco, 15023, Peru
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JSC Jerarsi Clinic
Tbilisi, 0167, Georgia
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Jasleen Hospital
Nagpur, 440012, India
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Johannes Wesling Klinikum Minden
Minden, 32429, Germany
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LLC "Innova"
Tbilisi, 0186, Georgia
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LLC Raymann
Tbilisi, 0186, Georgia
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LTD "New Plasma Clinic"
Batumi, 6010, Georgia
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LTD "Tbilisi Central Hospital"
Tbilisi, 0159, Georgia
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LTD "Tbilisi Heart Center"
Tbilisi, 0186, Georgia
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Limited Liability Company "Medical Centre 'Consilium Medical'", Clinical and Consultation Department
Kyiv, 04050, Ukraine
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Ltd. Mtskheta Street Clinic
Tbilisi, 0179, Georgia
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MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
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Makati Medical Center
Makati, 1229, Philippines
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Med Center "Ok!Clinic+" of Ltd Liability Com "Inter Ins of Clin Rsrch", Inpatient dprt, Unit of Ther, Rheuma and Cardio
Kyiv, 02091, Ukraine
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Medi Club Georgia Ltd.
Tbilisi, 0160, Georgia
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Medical Center "Center of Family Medicine Plus" LLC, Treatment and Prevention Department
Kyiv, 04210, Ukraine
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Medical Center "Harmoniia krasy", LLC
Kyiv, 01135, Ukraine
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Medical Center "Universal Clinic "Oberih"" of Limited Liability Company "Capital"
Kyiv, 03057, Ukraine
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Medical Center of the Limited Liability Company "Edelweiss Medics", Treatment and Prevention Department
Kyiv, 02002, Ukraine
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Medyczne Centrum Hetmańska
Poznan, 60-218, Poland
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Military Medical Academy
Belgrade, 11040, Serbia
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Morales Vargas Centro de Investigación S.C.
León, 37000, Mexico
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National Institute of Endocrinology Ltd.
Tbilisi, 0159, Georgia
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Nirmal Hospital Private Limited
Surat, 395002, India
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Northwest Houston Arthritis Center
Houston, Texas, 77090, United States
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Oaxaca contra el Cáncer A.C
Oaxaca City, 68000, Mexico
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Ospital ng Makati
Makati City, 1218, Philippines
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PCR Toluca - Phylasis Clinical Research
Toluca, 50090, Mexico
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Panorama Medical Centre
Cape Town, 7500, South Africa
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Parc Tauli Sabadell University Hospital
Barcelona, 08208, Spain
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Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 71-252, Poland
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Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
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Professional research Center INC
Miami, Florida, 33172, United States
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RB Wellness Clinic
Las Vegas, Nevada, 89102, United States
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San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014, United States
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Santa Sp. z o.o.
Lodz, 90-302, Poland
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Sarawak General Hospital
Kuching, 93586, Malaysia
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Servicios Reumatológicos SOMA E.I.R.L. / Clinica El Golf
San Isidro, 15076, Peru
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Shalby Hospitals
Ahmedabad, 380015, India
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Sociedad Médica del Aparato Locomotor S. A.
Providencia, 7510186, Chile
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Special Hospital for Rheumatic Diseases, Novi Sad
Novi Sad, 21000, Serbia
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St Luke's Medical Center Quezon City / University of Santo Tomas Hospital
Sampaloc, 1015, Philippines
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St Lukes Medical Center
Manila, 1102, Philippines
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St. Luke's Treatment and Diagnostic Center
Ivano-Frankivsk, 76019, Ukraine
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Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
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Tandem Clinical Research
Marrero, Louisiana, 70072, United States
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Tbilisi Heart and Vascular Clinic Ltd.
Tbilisi, 0159, Georgia
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Tbilisi Institute of Medicine
Tbilisi, 0160, Georgia
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Tectum Medical Research
Hollywood, Florida, 33024, United States
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Ternopil Regional Clinical Hospital
Ternopil, 46002, Ukraine
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Texas Arthritis Center
El Paso, Texas, 79902, United States
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The First Medical Center Ltd.
Tbilisi, 0180, Georgia
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The Medical City Clark
Pampanga, 2023, Philippines
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Tucson Clinical Research Institute, LLC
Tucson, Arizona, 85712, United States
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Twoja Przychodnia Poznańskie Centrum Medyczne
Poznan, 61-293, Poland
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UBAM Unidad Biomédica Avanzada Monterrey
Monterrey, 64460, Mexico
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UCSD Perlman Medical Offices
La Jolla, California, 92037-0943, United States
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ULS Guarda
Guarda, 6300-749, Portugal
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Unidad de Investigación de la Clinica International
San Borja, 15036, Peru
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Unidad de Investigación en Medicina Interna y Enfermedades Críticas / Hogar Clínica San Juan de Dios
Cayma, 04017, Peru
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Unidad de Investigación en Reumatología e Inmunología CSJB
San Juan de Lurigancho, 15431, Peru
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Unidade Local De Saude Lisboa Ocidental E.P.E.
Lisbon, 1349-019, Portugal
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Universiti Kebangsaan Malaysia - Medical Centre
Cheras, 56000, Malaysia
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University Clinical Center of Serbia
Belgrade, 11000, Serbia
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University Hospitals of Leicester Nhs Trust
Leicester, LE5 4PW, United Kingdom
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University of Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
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University of Pretoria
Pretoria, 0002, South Africa
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Universitätsklinikum Leipzig
Leipzig, 4103, Germany
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Universitätsklinikum Münster (UKM)
Münster, 48149, Germany
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Vital Pharma Research
Hialeah, Florida, 33016, United States
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Winelands Medical Research
Somerset West, 7130, South Africa
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Yashoda Hospital
Secunderabad, 500003, India
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iMedica s.r.o.
Brno, 60200, Czechia
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