A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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 macular edema or active uveitis detected by optical coherence tomography (OCT) during screening.

- 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 anti-arrhythmic 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05648500
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Idorsia Pharmaceuticals Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Idorsia Pharmaceuticals Ltd.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Bulgaria, Colombia, France, Greece, Korea, Republic of, Mexico, Philippines, Poland, Romania, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic

Arms & Interventions

Arms

Experimental: Cenerimod 4 mg

Participants will receive cenerimod once daily in addition to background SLE therapy.

Placebo Comparator: Matching placebo

Participants will receive matching placebo once daily in addition to background SLE therapy.

Interventions

Drug: - Cenerimod

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Providence Medical Foundation, Fullerton, California

Status

Recruiting

Address

Providence Medical Foundation

Fullerton, California, 92835

Site Contact

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