RECRUITING

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

Conditions

Lupus Erythematosus, Systemic Musculoskeletal and connective tissue disorders Connective Tissue Diseases Immune System Diseases Autoimmune Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-12-13

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05648500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 \[s.c.\]). * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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 \[s.c.\]).
* 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.

* 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.

Contacts and Locations

Study Contact

Idorsia Clinical Trial Information USA

CONTACT

+1 856 661 3721

idorsiaclinicaltrials@idorsia.com

Idorsia Clinical Trial Information Europe

CONTACT

+ 41 58 844 19 77

idorsiaclinicaltrials@idorsia.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Study Locations (Sites)

Providence Medical Foundation

Fullerton, California, 92835

United States

University of Colorado Denver

Aurora, Colorado, 80045

United States

RASF-Clinical Research Inc.

Boca Raton, Florida, 33486

United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765

United States

Omega Research MetroWest, LLC

DeBary, Florida, 32713

United States

SouthCoast Research Center, Inc.

Miami, Florida, 33136

United States

IRIS Research and Development, LLC

Plantation, Florida, 33324-2736

United States

Renew Health Clinical Research LLC

Tampa, Florida, 33607

United States

Augusta University

Augusta, Georgia, 30912

United States

Accurate Clinical Research Inc. - Lake Charles

Lake Charles, Louisiana, 70605

United States

Axon Clinical Research -Baltimore

Baltimore, Maryland, 21237

United States

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, 21740

United States

June DO, PC

Lansing, Michigan, 48911

United States

Bronx Care Health and Wellness Center

Bronx, New York, 10457

United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28210

United States

Shelby Research, LLC

Memphis, Tennessee, 38119-5214

United States

Allen Arthritis

Allen, Texas, 75013

United States

Accurate Clinical Research Inc.

Baytown, Texas, 77521

United States

Rheumatology Care Center, PLLC

Bellaire, Texas, 77041

United States

Metroplex Clinical Research Center

Dallas, Texas, 75231

United States

Houston MD Medspa and Wellness Clinic

Houston, Texas, 77084

United States

Accurate Clinical Research Inc.

Houston, Texas, 77089

United States

Sun Research Institute

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Idorsia Pharmaceuticals Ltd.

Clinical Trials, STUDY_DIRECTOR, Idorsia Pharmaceuticals Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2022-12-13

Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

Musculoskeletal and connective tissue disorders
Connective Tissue Diseases
Immune System Diseases
Autoimmune Diseases

Additional Relevant MeSH Terms

Lupus Erythematosus, Systemic