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A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus (OPUS-2)

Primary Purpose

Lupus Erythematosus, Systemic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cenerimod
Placebo
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Musculoskeletal and connective tissue disorders, Immune System Diseases, Autoimmune Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. An 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 Analogue Scale (VAS). 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, 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). British Isles Lupus Assessment Group-2004 (BILAG) Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale. Presence of at least one of the following items of serological evidence of active SLE or biological variables predictive of Type 1 Interferon (IFN-1) high signature (in a Screening sample as measured by central laboratory): Anti-dsDNA antibodies elevated to above normal, Complement C3 < lower limit of normal, Antinuclear Antibodies with a titer of at least 1:160, Anti-Smith antibody elevated to above normal, Platelets < 200 000/μL, Urine protein/creatinine ratio > 12.5 mg/mmol (110.5 mg/g). 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 intravenous (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 central nervous system lupus or active severe or unstable neuropsychiatric SLE characterized by: 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 Principal Investigator, 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 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 basal or squamous cell skin or mucosal lesions, including dysplasia and carcinoma in situ), lymphoproliferative disease, or history of total lymphoid irradiation. 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) at screening assessment. 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, tacrolimus, sirolimus, mizoribine, 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, within 12 months prior to Randomization. Treatment with anifrolumab within 12 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.

Sites / Locations

  • Hope Clinical Trials, Inc.Recruiting
  • Vital Pharma ResearchRecruiting
  • San Marcus Research Clinic, Inc.Recruiting
  • D&H National Research Centers INCRecruiting
  • Saint Paul Rheumatology, P.A.Recruiting
  • Altoona Center for Clinical Research Department of RheumatologyRecruiting
  • Northwest Houston Arthritis CenteerRecruiting
  • Biomedica Research GroupRecruiting
  • Sociedad Médica del Aparato Locomotor S. A.Recruiting
  • Enroll SpARecruiting
  • Clinical Research Chile SpARecruiting
  • Hospital San José de VictoriaRecruiting
  • iMedica s.r.o.Recruiting
  • Institute of Rheumatology PragueRecruiting
  • LTD "New Plasma Clinic"Recruiting
  • Institute of Clinical Cardiology, LtdRecruiting
  • LTD "Tbilisi Central Hospital"Recruiting
  • National Institute of Endocrinology Ltd.Recruiting
  • Tbilisi Heart and Vascular Clinic Ltd.Recruiting
  • Aversi Clinic LTDRecruiting
  • Medi Club Georgia Ltd.Recruiting
  • Ltd. Mtskheta Street ClinicRecruiting
  • The First Medical Center Ltd.Recruiting
  • LLC "Innova"Recruiting
  • LLC RaymannRecruiting
  • LTD "Tbilisi Heart Center"Recruiting
  • Städtisches Klinikum Karlsruhe gGmbHRecruiting
  • Universitätsklinikum LeipzigRecruiting
  • Johannes Wesling Klinikum MindenRecruiting
  • Universitätsklinikum Münster (UKM)Recruiting
  • Iizuka HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • Chukyo HospitalRecruiting
  • Nagoya City University HospitalRecruiting
  • Shinkenko ClinicRecruiting
  • Tomakomai City HospitalRecruiting
  • Juntendo University Urayasu HospitalRecruiting
  • Medyczne Centrum HetmańskaRecruiting
  • Twoja Przychodnia Poznańskie Centrum MedyczneRecruiting
  • MICS Centrum Medyczne WarszawaRecruiting
  • Centro Reumatologico de CaguasRecruiting
  • GCM Medical Group, PSCRecruiting
  • Parc Tauli Sabadell University HospitalRecruiting
  • Clinica Gaias SantiagoRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Hospital Universitario Doctor PesetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cenerimod 4 mg

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline to Month 12 in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score
This endpoint is based on the SLEDAI-2K index, modified to exclude leukopenia. All values of mSLEDAI-2K from baseline through Month 12 visits will be accounted for in the assessment of this endpoint.

Secondary Outcome Measures

Response on Systemic Lupus Erythematosus Responder Index (SRI) at Month 12
Response on SRI-4 is defined as: Reduction from baseline of at least 4 points in the 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, and No violation of protocol-specified medication rules detailed in the core protocol.
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.
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations
Response is defined as: No increase in the overall mSLEDAI-2K score, and Remission (score of zero) from baseline in the mSLEDAI-2K score of mucocutaneous manifestations.

Full Information

First Posted
January 3, 2023
Last Updated
October 24, 2023
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05672576
Brief Title
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Acronym
OPUS-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to see how well cenerimod is in reducing 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Musculoskeletal and connective tissue disorders, Immune System Diseases, Autoimmune Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cenerimod 4 mg
Arm Type
Experimental
Arm Description
Participants will receive cenerimod once daily in addition to background SLE therapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo once daily in addition to background SLE therapy.
Intervention Type
Drug
Intervention Name(s)
Cenerimod
Other Intervention Name(s)
ACT-334441
Intervention Description
Cenerimod will be supplied as film-coated tablets at the dose of 4 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
Primary Outcome Measure Information:
Title
Change from baseline to Month 12 in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score
Description
This endpoint is based on the SLEDAI-2K index, modified to exclude leukopenia. All values of mSLEDAI-2K from baseline through Month 12 visits will be accounted for in the assessment of this endpoint.
Time Frame
Day 1 (pre-dose baseline) to Month 12
Secondary Outcome Measure Information:
Title
Response on Systemic Lupus Erythematosus Responder Index (SRI) at Month 12
Description
Response on SRI-4 is defined as: Reduction from baseline of at least 4 points in the 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, and No violation of protocol-specified medication rules detailed in the core protocol.
Time Frame
Day 1 (pre-dose baseline) to Month 12
Title
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Description
A response is defined as a reduction of at least 4 points from baseline.
Time Frame
Day 1 (pre-dose baseline) to Month 12
Title
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations
Description
Response is defined as: No increase in the overall mSLEDAI-2K score, and Remission (score of zero) from baseline in the mSLEDAI-2K score of mucocutaneous manifestations.
Time Frame
Day 1 (pre-dose baseline) to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. An 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 Analogue Scale (VAS). 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, 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). British Isles Lupus Assessment Group-2004 (BILAG) Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale. Presence of at least one of the following items of serological evidence of active SLE or biological variables predictive of Type 1 Interferon (IFN-1) high signature (in a Screening sample as measured by central laboratory): Anti-dsDNA antibodies elevated to above normal, Complement C3 < lower limit of normal, Antinuclear Antibodies with a titer of at least 1:160, Anti-Smith antibody elevated to above normal, Platelets < 200 000/μL, Urine protein/creatinine ratio > 12.5 mg/mmol (110.5 mg/g). 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 intravenous (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 central nervous system lupus or active severe or unstable neuropsychiatric SLE characterized by: 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 Principal Investigator, 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 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 basal or squamous cell skin or mucosal lesions, including dysplasia and carcinoma in situ), lymphoproliferative disease, or history of total lymphoid irradiation. 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) at screening assessment. 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, tacrolimus, sirolimus, mizoribine, 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, within 12 months prior to Randomization. Treatment with anifrolumab within 12 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idorsia Clinical Trial Information USA
Phone
+1 856 661 3721
Email
idorsiaclinicaltrials@idorsia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Idorsia Clinical Trial Information Europe
Phone
+ 41 58 844 19 77
Email
idorsiaclinicaltrials@idorsia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Hope Clinical Trials, Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Pharma Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
San Marcus Research Clinic, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H National Research Centers INC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Paul Rheumatology, P.A.
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Name
Altoona Center for Clinical Research Department of Rheumatology
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Houston Arthritis Centeer
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Name
Biomedica Research Group
City
Providencia
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Name
Sociedad Médica del Aparato Locomotor S. A.
City
Providencia
ZIP/Postal Code
7510186
Country
Chile
Individual Site Status
Recruiting
Facility Name
Enroll SpA
City
Santiago
ZIP/Postal Code
7500587
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Research Chile SpA
City
Valdivia
ZIP/Postal Code
5110683
Country
Chile
Individual Site Status
Recruiting
Facility Name
Hospital San José de Victoria
City
Victoria
ZIP/Postal Code
4720001
Country
Chile
Individual Site Status
Recruiting
Facility Name
iMedica s.r.o.
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Institute of Rheumatology Prague
City
Praha 2
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
LTD "New Plasma Clinic"
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Institute of Clinical Cardiology, Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD "Tbilisi Central Hospital"
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
National Institute of Endocrinology Ltd.
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi Heart and Vascular Clinic Ltd.
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Aversi Clinic LTD
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Medi Club Georgia Ltd.
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd. Mtskheta Street Clinic
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
The First Medical Center Ltd.
City
Tbilisi
ZIP/Postal Code
0180
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LLC "Innova"
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LLC Raymann
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD "Tbilisi Heart Center"
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Städtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster (UKM)
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Iizuka Hospital
City
Iizuka City
ZIP/Postal Code
820-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chukyo Hospital
City
Nagoya-shi
ZIP/Postal Code
457-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinkenko Clinic
City
Naha-shi
ZIP/Postal Code
900-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tomakomai City Hospital
City
Tomakomai-shi
ZIP/Postal Code
053-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Urayasu Hospital
City
Urayasu
ZIP/Postal Code
279-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medyczne Centrum Hetmańska
City
Poznań
ZIP/Postal Code
60-218
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia Poznańskie Centrum Medyczne
City
Poznań
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Reumatologico de Caguas
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
GCM Medical Group, PSC
City
San Juan
ZIP/Postal Code
917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Parc Tauli Sabadell University Hospital
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Gaias Santiago
City
Santiago De Compostela
ZIP/Postal Code
15702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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