Clinical trial • Phase III • Immunology

CENERIMOD for Systemic lupus erythematosus (moderate to severe)

Phase III trial of CENERIMOD for Systemic lupus erythematosus (moderate to severe).

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus (moderate to severe)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
25-09-2024
First CTIS Authorization Date
24-10-2024

Trial design

Randomised, placebo (cenerimod matching placebo) oral, once daily, matching schedule to active; background sle therapy continued per inclusion criteria.-controlled Phase III trial across 31 sites in Czechia, Germany, Portugal and others.

Randomised
Yes
Comparator
Placebo (Cenerimod matching placebo) oral, once daily, matching schedule to active; background SLE therapy continued per inclusion criteria.
Target Sample Size
328
Trial Duration For Participant
605

Eligibility

Recruits 328 Vulnerable population is selected. Informed consent must be provided: Screening starts with the full signature of the ICF (subject, investigator/delegate, and/or any other applicable third party). Subjects unable to fully understand the ICF (for example because of severe neuropsychiatric SLE) are excluded. No specific assent process for minors is described (trial is for adult subjects)..

Pregnancy Exclusion
Pregnant, planning to become pregnant up to Final Study Visit, or lactating women.
Vulnerable Population
Vulnerable population is selected. Informed consent must be provided: Screening starts with the full signature of the ICF (subject, investigator/delegate, and/or any other applicable third party). Subjects unable to fully understand the ICF (for example because of severe neuropsychiatric SLE) are excluded. No specific assent process for minors is described (trial is for adult subjects).

Inclusion criteria

  • {"criterion_text":"- Signed Informed Consent Form prior to any study-mandated procedure."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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\"."}
  • {"criterion_text":"- Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine)."}
  • {"criterion_text":"- Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day)."}
  • {"criterion_text":"- Azathioprine (≤ 2 mg/kg/day)."}
  • {"criterion_text":"- Methotrexate (≤ 25 mg/week)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Belimumab (≤10 mg/kg every 4 weeks intravenously [i.v.], or 200 mg/week subcutaneously [s.c.])."}
  • {"criterion_text":"- Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening."}
  • {"criterion_text":"- Treatment with OCS must have been started at least 30 days prior to Screening."}
  • {"criterion_text":"- For women of childbearing potential (WoCBP): -\tNegative serum pregnancy test at Screening."}
  • {"criterion_text":"- For women of childbearing potential (WoCBP): -\tAgreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation."}
  • {"criterion_text":"- For women of childbearing potential (WoCBP): -\tAgreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation."}
  • {"criterion_text":"- A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale."}
  • {"criterion_text":"- Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory): -\tAnti-dsDNA antibodies elevated above normal."}
  • {"criterion_text":"- Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory): -\tAntinuclear antibodies with a titer of at least 1:160."}
  • {"criterion_text":"- Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory): -\tAnti-Smith antibody elevated above normal."}
  • {"criterion_text":"- Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine) (must be stable for at least 30 days prior to Randomization)."}
  • {"criterion_text":"- Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44 g/day) (must be stable for at least 30 days prior to Randomization)."}
  • {"criterion_text":"- Azathioprine (≤ 2 mg/kg/day) (must be stable for at least 30 days prior to Randomization)."}
  • {"criterion_text":"- Methotrexate (≤ 25 mg/week) (must be stable for at least 30 days prior to Randomization)."}
  • {"criterion_text":"- 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) (must be stable; OCS stable for at least 15 days prior to Randomization)."}
  • {"criterion_text":"- Belimumab (≤ 10 mg/kg every 4 weeks i.v. or ≤ 200 mg/week s.c.) (must be stable for at least 30 days prior to Randomization)."}
  • {"criterion_text":"- WoCBP must have a negative urine pregnancy test at Randomization."}

Exclusion criteria

  • {"criterion_text":"- Pregnant, planning to become pregnant up to Final Study Visit, or lactating women."}
  • {"criterion_text":"- 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: •\tThat would make the subject unable to fully understand the ICF; OR •\tWhere, 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."}
  • {"criterion_text":"- •\tHistory or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders. •\tSubjects 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. •\tResting Heart Rate < 50 bpm as measured by the 12-lead ECG at Screening or at Randomization. •\tAn elevated QT interval corrected according to Fridericia's formula (QTcF) interval of > 470 ms (females) / > 450 ms (males) at Screening or at Randomization."}
  • {"criterion_text":"- •\tHistory 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. •\tHistory 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."}
  • {"criterion_text":"- • 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. •\tPresence 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.•\tHistory 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); -\themoglobin < 7 g/dL; - white blood cell count < 2000/μL (2.0 × 10^9/L); or -\tplatelets < 25000/μL (25 × 10^9/L). • Estimated glomerular filtration rate < 15 mL/min/1.73 m^2."}
  • {"criterion_text":"- • Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: -\tβ-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. • Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization. • Treatment with anifrolumab within 6 months prior to Randomization. •\tTreatment 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. •\tTreatment 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 any of the following medications any time prior to Screening: -\tAlemtuzumab; -\tSphingosine-1-phosphate receptor modulators (e.g., fingolimod). - Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Response on Systemic Lupus Erythematosus Responder Index (SRI-4) at Month 12 compared to baseline.","definition_or_measurement_approach":"SRI-4 measured at Month 12 versus baseline (Systemic Lupus Erythematosus Responder Index 4 at Month 12 compared to baseline)."}

Secondary endpoints

  • {"endpoint_text":"- Response on British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline.","definition_or_measurement_approach":"BICLA response assessed at Month 12 compared to baseline."}
  • {"endpoint_text":"- Time to first confirmation of a 4-month sustained mSLEDAI-2K response, defined as a reduction of at least 4 points from baseline.","definition_or_measurement_approach":"Time-to-event (first confirmation) where sustained response is defined as ≥4-point reduction from baseline sustained for 4 months."}
  • {"endpoint_text":"- Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers), defined as: • No increase in the overall mSLEDAI-2K score excluding mucocutaneous manifestations, and • Remission (score of zero) from baseline in the mSLEDAI-2K score of mucocutaneous manifestations.","definition_or_measurement_approach":"Time-to-event (first confirmation) where sustained mucocutaneous response requires no increase in overall mSLEDAI-2K excluding mucocutaneous manifestations and remission (score=0) in mucocutaneous mSLEDAI-2K score from baseline, sustained for 4 months."}

Recruitment

Planned Sample Size
328
Recruitment Window Months
46
Consent Approach
Informed consent: subjects must sign a full Informed Consent Form (ICF) prior to any study-mandated procedure; screening period starts with full signature of the ICF (subject, investigator/delegate, and/or any other applicable third party). Country-specific subject information and ICF documents (L1_SIL-ICF and translations) are provided; documents available in multiple languages (English, Czech, German, Spanish, Polish, Portuguese as per submitted documents). No separate assent process for minors is provided (trial enrols adults).

Methods

  • Country-specific recruitment arrangements documents submitted (K1/K2). Materials listed include subject posters, subject leaflets, participant cards and payment card materials (e.g., 'Payment card - ScoutPass EUR', 'Payment card - Reloadable', study brochures) for Czechia, Germany, Portugal, Spain, Poland.
  • GP letter (Portugal) listed among subject information materials (L1_GP letter_pt-PT).
  • Subject information and informed consent forms and participant-facing questionnaires available in multiple local languages (documents L1, D4 and questionnaires).

Geography

Total Number Of Sites
31
Total Number Of Participants
92

Czechia

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
422
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
iMedica s.r.o.
Department Name
iMedica, s.r.o.
Contact Person Name
Angelika Lapčíková
Contact Person Email
int.ambulance@gmail.com
Site Name
Revmatologicky Ustav
Department Name
Revmatologický ustav
Contact Person Name
Dana Tegzová
Contact Person Email
tegzova@revma.cz

Germany

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
414
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
Universitaetsklinikum Muenster AöR
Department Name
Sektion für Rheumatologie und klinische Immunologie, Medizinische Klinik D
Contact Person Name
Gert Gabriels
Contact Person Email
eva.mickholz@ukmuenster.de
Site Name
Johannes Wesling Klinikum Minden
Department Name
Studiensekretariat Rheumatologie, Klinik für Rheumatologie und Klinische Immunologie
Contact Person Name
Gunter Aßmann
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Studienambulanz Rheumatologie, Klinik & Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
Contact Person Name
Ulf Wagner
Contact Person Email
rheuma@medizin.uni-leipzig.de
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
ITMP
Contact Person Name
Michaela Köhm

Portugal

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
402
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Unidade Local De Saude Da Guarda E.P.E.
Department Name
Rheumatology
Contact Person Name
Claudia Vaz
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Rheumatology
Contact Person Name
Patricia Pinto
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Rheumatology
Contact Person Name
Celia Ribeiro
Contact Person Email
vasteixeira@chua.min-saude.pt
Site Name
Instituto Portugues De Reumatologia
Department Name
Rheumatology
Contact Person Name
Luis Miguel Miranda
Contact Person Email
lcunhamiranda@hotmail.com
Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Autoimmune unit
Contact Person Name
José Alves
Contact Person Email
Jose.alves@nms.unl.pt
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Internal Medicine
Contact Person Name
Gloria Alves
Contact Person Email
gloriasousalves@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Rheumatology
Contact Person Name
Ana Mourão
Contact Person Email
afilipamourao@gmail.com
Site Name
Unidade Local De Saude Do Alto Ave E.P.E. (duplicate entry not provided?)

Spain

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
388
Number Of Sites
11
Number Of Participants
11

Sites

Site Name
Hospital Clinico San Carlos
Department Name
Rheumatology
Contact Person Name
Lydia Abasolo
Contact Person Email
lydia.abasolo@salud.madrid.org
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Rheumatology
Contact Person Name
Juan Jose Alegre Sancho
Contact Person Email
alegre_juasan@gva.es
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Rheumatology
Contact Person Name
Paula Cejas Caceres
Contact Person Email
pcejashil@gmail.com
Site Name
Hospital Universitario Rio Hortega
Department Name
Autoinmmune Diseases
Contact Person Name
Maria Julia Barbado Ajo
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Rheumatology
Contact Person Name
Pilar Trenor Larraz
Contact Person Email
pilartrenor@gmail.com
Site Name
Clinica Gaias Santiago
Department Name
Rheumatology
Contact Person Name
Juan Antonio Garcia Meijide
Contact Person Email
meijithe@hotmail.com
Site Name
Hospital Universitario Infanta Leonor
Department Name
Rheumatology
Contact Person Name
María Teresa Navío
Contact Person Email
mariateresanavio@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Rheumatology
Contact Person Name
María Jesús Garcia
Contact Person Email
N@A
Site Name
Hospital Universitari Vall D Hebron
Department Name
Rheumatology
Contact Person Name
Josefina Cortes
Contact Person Email
fina.cortes@vhir.org
Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology
Contact Person Name
Joan Calvet Fontova
Contact Person Email
joan.calvet.fontova@gmail.com
Site Name
Accellacare Espana S.L.
Department Name
Rheumatology
Contact Person Name
Raul Veiga
Contact Person Email
grupo9123@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
24-11-2024
Latest Decision Or Authorization Date
14-12-2025
Processing Time Days
385
Number Of Sites
6
Number Of Participants
27

Sites

Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
"Szpital Biziela" Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Contact Person Name
Piotr Ignaczak
Contact Person Email
pmi@autograf.pl
Site Name
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia Poznańskie Centrum Medyczne
Contact Person Name
Agata Wytyk-Nowak
Contact Person Email
wytyk@twojaprzychodnia.com
Site Name
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu
Department Name
Oddział Reumatologii, Rehabilitacji i Chorób Wewnętrznych
Contact Person Name
Włodzimierz Samborski
Contact Person Email
wsamborski@orsk.pl
Site Name
Santa Sp. z o.o.
Department Name
Santa Sp. z o.o.
Contact Person Name
Tomasz Budlewski
Site Name
Piotr Leszczyński Medyczne Centrum Hetmańska Piotr Leszczyński
Department Name
Medyczne Centrum Hetmańska Piotr Leszczyński
Contact Person Name
Piotr Leszczyński
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa
Contact Person Name
Katarzyna Romanowska-Próchnicka

Sponsor

Primary sponsor

Full Name
Viatris Innovation GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Keyrus Life Science Innovation","duties_or_roles":"Biostatistics; code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Flying Study Team GbR","duties_or_roles":"code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Hungary","full_name":"Precision for Medicine (HU) Kft.","duties_or_roles":"codes: 1; 'Contact for contracts with hospitals, investigators, other parties as required'; 2; 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Dxterity Diagnostics Inc.","duties_or_roles":"Whole blood Biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
  • {"country":"Portugal","full_name":"Leon Research S.L. Sucursal Em Portugal","duties_or_roles":"codes: 1; 'Contact for contracts with hospitals, investigators, other parties as required'; 2; 5","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"DATAMAP-Gesellschaft fuer Datenmanagement Datenanalyse und Datenpraesentation mbH","duties_or_roles":"code 10","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient expenses reimbursement, Patient travel booking","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Swiss Tropical And Public Health Institute (Swiss TPH)","duties_or_roles":"Biobank Storage facility","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eCOA services (ePRO and data capture of SLE assessments) on tablet-based data capture platform","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Competence In Scientific Services Eggenreich & Gschanes GmbH","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Crisalis LLC","duties_or_roles":"Investigator learning portal for questionnaires","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Winicker-Norimed GmbH Medizinische Forschung","duties_or_roles":"Administrative Support; code 5","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Cenerimod 4 mg
Active Substance
CENERIMOD
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (prodAuthStatus=1)
Starting Dose
4 mg
Dose Levels
4 mg
Frequency
once daily
Maximum Dose
4 mg
Investigational Product Name
Cenerimod matching placebo
Modality
Other
Routes Of Administration
ORAL (matching placebo)
Route
oral
Frequency
once daily
Combination Treatment
Yes

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