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    Summary
    EudraCT Number:2022-002814-17
    Sponsor's Protocol Code Number:ID-064A301
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2022-002814-17
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code numberID-064A301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIdorsia Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trials Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4158844 1917
    B.5.5Fax number+4158844 0108
    B.5.6E-mailclinical-trials-disclosure@idorsia.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCenerimod
    D.3.2Product code ACT-334441
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB204006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe systemic lupus erythematosus
    E.1.1.1Medical condition in easily understood language
    Lupus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of cenerimod 4 mg at reducing disease activity compared to placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of cenerimod 4 mg to control the disease compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening 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.
    • 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”.
    • Currently treated with one or more of the following SLE background medications:
    o Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine).
    o Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day).
    o Azathioprine (≤ 2 mg/kg/day).
    o Methotrexate (≤ 25 mg/week).
    o 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.
    o 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):
    o Negative serum pregnancy test at Screening.
    o Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.
    o Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.

    Randomization criteria:
    • 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):
    o Anti-dsDNA antibodies elevated to above normal,
    o Complement C3 < lower limit of normal,
    o Antinuclear Antibodies with a titer of at least 1:160,
    o Anti-Smith antibody elevated to above normal,
    o Platelets < 200 000/μL,
    o 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):
    o Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine);
    o Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day);
    o Azathioprine (≤ 2 mg/kg/day);
    o Methotrexate (≤ 25 mg/week);
    o 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).
    o 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.
    E.4Principal 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 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:
    o That would make the subject unable to fully understand the ICF; OR
    o 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.
    • 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:
    o lymphocyte count < 500 /μL (0.5 × 10^9/L);
    o hemoglobin < 7 g/dL;
    o white blood cell count < 2000/μL (2.0 × 10^9/L); or
    o 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:
    o β-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other antiarrhythmic or heart-rate -lowering systemic therapy.
    o 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:
    o Cyclophosphamide, cyclosporine, tacrolimus, sirolimus, mizoribine, etc.
    o Pulse methylprednisolone.
    o Vaccination with live vaccines.
    • Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization.
    • Treatment with anifrolumab within 12 months prior to Randomization.
    • Treatment with the following medications within 90 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:
    o Leflunomide.
    o 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 any of the following medications any time prior to Screening:
    o Alemtuzumab;
    o Sphingosine-1-phosphate receptor modulators (e.g., fingolimod);
    o Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Month 12 in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K).
    [SLEDAI-2K (modified to exclude leukopenia, thus mSLEDAI-2K)].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 (pre-dose baseline) to Month 12
    E.5.2Secondary end point(s)
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 (pre-dose baseline) to Month 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, biomarkers, quality-of-life.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    China
    Colombia
    Korea, Republic of
    Malaysia
    Mexico
    Philippines
    Taiwan
    Thailand
    United States
    France
    Poland
    Bulgaria
    Romania
    Greece
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit (LSLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 408
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who complete the 12-month double-blind treatment period will be offered to enroll into an open-label extension (OLE) conducted under a separate protocol in which all subjects will receive cenerimod 4 mg, until the last subject will have completed 1 year in the OLE, provided the extension study protocol has been approved in their country/ site by the regulatory authority and ethics committee. Subjects that do not enter the OLE will receive Standard of Care according to local practice.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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