Clinical trial NCT05648500: A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Keywords: Musculoskeletal and connective tissue disorders
Connective Tissue Diseases
Immune System Diseases
Autoimmune Diseases
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.
* A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include "leukopenia".
* British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system.
* Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale.
* Currently treated with one or more of the following SLE background medications:

  * Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine).
  * Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day).
  * Azathioprine (≤ 2 mg/kg/day).
  * Methotrexate (≤ 25 mg/week).
  * Oral Corticosteroids (OCS):

    * if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
    * if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
  * Belimumab (≤10 mg/kg every 4 weeks intravenously \[i.v.\], or 200 mg/week subcutaneously \[s.c.\]).

Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening.

• For women of childbearing potential (WoCBP):

* Negative serum pregnancy test at Screening.
* Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.
* Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.

Inclusion criteria at randomization:

* A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
* BILAG Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system.
* PGA score ≥ 1.0 on a 0 to 3 visual analog scale.
* Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory):

  * Anti-dsDNA antibodies elevated above normal,
  * Antinuclear antibodies with a titer of at least 1:160,
  * Anti-Smith antibody elevated above normal.
* Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization):

  * Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine);
  * Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day);
  * Azathioprine (≤ 2 mg/kg/day);
  * Methotrexate (≤ 25 mg/week);
  * OCS:

    * if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
    * if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
  * Belimumab (≤ 10 mg/kg every 4 weeks i.v. or ≤ 200 mg/week s.c.).
* WoCBP must have a negative urine pregnancy test at Randomization.

Main Exclusion Criteria:

* Pregnant, planning to be become pregnant up to Final Study Visit, or lactating women.
* Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex:

  * That would make the subject unable to fully understand the ICF; OR
  * Where, in the opinion of the investigator/delegate, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.
* A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.
* History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.
* Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within 6 months prior to Screening.
* Resting heart rate \< 50 bpm as measured by the 12-lead ECG at Screening or at Randomization.
* An elevated QT interval corrected according to Fridericia's formula (QTcF) interval of \> 470 ms (females) / \> 450 ms (males) at Screening or at Randomization.
* History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history, lung function, and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.
* History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening.
* History or presence of malignancy (except for surgically excised and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma), lymphoproliferative disease, or history of total lymphoid irradiation within 10 years prior to Screening.
* Presence of macular edema or active uveitis detected by optical coherence tomography (OCT) during screening.
* History of chronic liver or biliary disease (other than Gilbert's Syndrome) or subjects with alanine aminotransferase or aspartate aminotransferase \> 3 × Upper Limit of Normal (ULN) or total bilirubin \> 1.5 × ULN (unless in the context of known Gilbert's Syndrome).
* Significant hematology abnormality at screening assessment:

  * lymphocyte count \< 500 /μL (0.5 × 10\^9/L);
  * hemoglobin \< 7 g/dL;
  * white blood cell count \< 2000/μL (2.0 × 10\^9/L); or
  * platelets \< 25000/μL (25 × 10\^9/L).
* Estimated glomerular filtration rate \< 15 mL/min/1.73 m\^2.
* Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:

  * β-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other anti-arrhythmic or heart-rate -lowering systemic therapy.
  * QT-prolonging drugs with known risk of torsade de pointes irrespective of indication.
* Treatment with the following medications within 30 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:

  * Cyclophosphamide, cyclosporine, voclosporin, tacrolimus, sirolimus, etc.
  * Pulse methylprednisolone.
  * Vaccination with live vaccines (including live vaccines for COVID-19).
* Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization.
* Treatment with the following medications within 90 days or 5 half-lives of the medication (whichever is longer) prior to Randomization:

  * Leflunomide.
  * i.v. immunoglobulins.
* Treatment with any investigational agent within 90 days or 5 half-lives of the drug (whichever is longer) prior to Randomization.
* Treatment with B cell-depleting biological agents (e.g., rituximab or ocrelizumab) or biological immunosuppressive agents (e.g., anti-tumor necrosis factor \[TNF\], anti-interleukin \[IL\]-1, anti-IL6 therapies), within 12 months prior to Randomization.
* Treatment with anifrolumab within 6 months prior to Randomization.
* Treatment with any of the following medications any time prior to Screening:

  * Alemtuzumab,
  * Sphingosine-1-phosphate receptor modulators (e.g., fingolimod),
  * Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod.

Primary outcomes:
measure: Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline
timeFrame: At Month 12 compared to Day 1 (pre-dose baseline)
Secondary outcomes:
measure: Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline
timeFrame: At Month 12 compared to Day 1 (pre-dose baseline)
measure: Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
timeFrame: Day 1 (pre-dose baseline) to Month 12
measure: Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers)
timeFrame: Day 1 (pre-dose baseline) to Month 12
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Huntington Park
country: United States
facility: California Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Boca Raton
country: United States
facility: RASF-Clinical Research Inc.
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: DeBary
country: United States
facility: Omega Research MetroWest, LLC
state: Florida
city: Miami
country: United States
facility: SouthCoast Research Center, Inc.
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC
state: Florida
city: Tampa
country: United States
facility: Renew Health Clinical Research LLC
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Orland Park
country: United States
facility: Advance Quality Medical Research
state: Illinois
city: Lake Charles
country: United States
facility: Accurate Clinical Research Inc. - Lake Charles
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine section of Rheumatology
state: Louisiana
city: Baltimore
country: United States
facility: Axon Clinical Research -Baltimore
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Lansing
country: United States
facility: June DO, PC
state: Michigan
city: Bronx
country: United States
facility: Bronx Care Health and Wellness Center
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Smithfield
country: United States
facility: Superior Clinical Reseach LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma College of Medicine
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Health Systems/ Lewis Katz School of Medicine
state: Pennsylvania
city: Memphis
country: United States
facility: Shelby Research, LLC
state: Tennessee
city: Allen
country: United States
facility: Allen Arthritis
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Research Inc.
state: Texas
city: Bellaire
country: United States
facility: Rheumatology Care Center, PLLC
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Houston MD Medspa and Wellness Clinic
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Buenos Aires
country: Argentina
facility: Instituto Medico CER
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigacion
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Ramos Mejia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Arsema Clinica Adventista Belgrano
city: Mendoza
country: Argentina
facility: IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología
city: Rosario
country: Argentina
facility: Instituto CAICI SRL
city: San Miguel de Tucumán
country: Argentina
facility: Centro Integral de Reumatología
city: San Miguel De Tucumán
country: Argentina
facility: ICT (Investigaciones Clínicas Tucumán)
city: Tucuman
country: Argentina
facility: Centro de investigaciones medicas Tucuman
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte
city: Brasilia
country: Brazil
facility: Hospital Brasília
city: Juiz De Fora
country: Brazil
facility: Centro Mineiro de Pesquisas
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde
city: Porto Alegre
country: Brazil
facility: Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medico S/S
city: Rio de Janeiro
country: Brazil
facility: IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas
city: Salvador
country: Brazil
facility: SER - Serviços Especializados em Reumatologia da Bahia
city: Santa Cecília
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: São Bernardo do Campo
country: Brazil
facility: Centro Multidiciplinar de Estudos Clínicos- CEMEC
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: São Paulo
country: Brazil
facility: CPClin - Centro de Pesquisas Clínicas
city: Uberlandia
country: Brazil
facility: Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU
city: Plovdiv
country: Bulgaria
facility: University Multi-profile Hospital for Active Treatment - Plovdiv AD
city: Plovdiv
country: Bulgaria
facility: "University Multiprofile Hospital for Active Treatment - Pulmed" OOD
city: Plovdiv
country: Bulgaria
facility: Medical Center ArtMed OOD
city: Plovdiv
country: Bulgaria
facility: Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.
city: Ruse
country: Bulgaria
facility: DCC 1 Ruse
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost
city: Varna
country: Bulgaria
facility: DCC Equita EOOD
city: Barranquilla
country: Colombia
facility: Clínica de la costa Ltda.
city: Bogota
country: Colombia
facility: IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)
city: Bogotá
country: Colombia
facility: Bluecare salud SAS
city: Bucaramanga
country: Colombia
facility: SERVIMED S.A.S Bucaramanga
city: Cali
country: Colombia
facility: Fundación Valle de Lili
city: Cali
country: Colombia
facility: Centro de Estudios de Reumatología y Dermatología
city: Chía
country: Colombia
facility: Preventive Care SAS
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe
city: Monteria
country: Colombia
facility: Fundación Centro De Excelencia En Enfermedades Crónicas No Transmisibles-FUNCENTRA
city: Zipaquira
country: Colombia
facility: Healthy Medical Center SAS
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Saint-Denis
country: France
facility: CHU Félix Guyon Site Nord
city: Toulouse
country: France
facility: CHU de Purpan
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Athens "Hippokration"
city: Athens
country: Greece
facility: University General Hospital "Attikon"
city: Athen
country: Greece
facility: General Hospital of Athens "Laiko"
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Patras
country: Greece
facility: General University Hospital of Patras
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Hippokration"
city: Thessaloniki
country: Greece
facility: 424 General Military Hospital
city: Thessaloníki
country: Greece
facility: Euromedica - Kyanos Stavros
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Catholic University of Daegu (Daegu Catholic University Medical Center)
city: Junggu
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital, Seongdong-gu
city: Seoul
country: Korea, Republic of
facility: Ewha University Mokdong Hospital, Yangcheon-gu
city: Seoul
country: Korea, Republic of
facility: KonKuk University Medical Center, Gwangjin-gu
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu
city: Ciudad de México
country: Mexico
facility: Biológicos Especializados S.A. de C.V.
city: Ciudad de México
country: Mexico
facility: CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
city: Cuernavaca
country: Mexico
facility: Panamerican Clinical Research Mexico S.A. de C.V.
city: Guadalajara
country: Mexico
facility: Consultorio Privado de Especialidad
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigación Básica y Clínica, S.C.
city: León
country: Mexico
facility: Consultorio Médico de Reumatología - Hospital Aranda de la Parra
city: Morelia
country: Mexico
facility: Centro de Investigación Clínica Chapultepec S. A. de C. V.
city: Mérida
country: Mexico
facility: Unidad de Atención Médica e Investigación en Salud
city: Querétaro
country: Mexico
facility: SMIQ, S. de R.L. de C.V.
city: San Luis Potosi
country: Mexico
facility: Unidad de Investigaciones Reumatológicas A.C
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
city: Cebu City
country: Philippines
facility: Chong-Hua Hospital
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Lipa
country: Philippines
facility: Mary Mediatrix Medical Center
city: Makati
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: UP-PGH
city: Quezon City
country: Philippines
facility: Far Eastern University - Nicanor Reyes Medical Foundation
city: Santa Cruz
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
city: Częstochowa
country: Poland
facility: Centrum Medyczne Pratia Częstochowa
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Kraków
country: Poland
facility: Małopolskie Badania Kliniczne
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Lublin
country: Poland
facility: Zespół Poradni Specjalistycznych REUMED
city: Wrocław
country: Poland
facility: Malwa-Med Iwona Chlebicka
city: Brasov
country: Romania
facility: Neomed Brasov
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. Ion Cantacuzino
city: Bucuresti
country: Romania
facility: SC Sana Monitoring SRL
city: Bucuresti
country: Romania
facility: Delta Health Care SRL
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean de Urgentã Craiova
city: Râmnicu Vâlcea
country: Romania
facility: SC Medaudio-Optica SRL
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei City
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei City
country: Taiwan
facility: TRI-Service General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Vajira Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Songkla
country: Thailand
facility: Songklanagarind Hospital
city: Cherkasy
country: Ukraine
facility: Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"
city: Khmelnytskyi
country: Ukraine
facility: Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council
city: Kyiv
country: Ukraine
facility: Clinic of Modern Rheumatology
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"
city: Kyiv
country: Ukraine
facility: State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin
city: Kyiv
country: Ukraine
facility: Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni
city: Lviv
country: Ukraine
facility: Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine
city: Lviv
country: Ukraine
facility: Medical Centre "Academical Medical Group" LLC
city: Uzhhorod
country: Ukraine
facility: Uzhhorod City Multidisciplinary Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department
city: Vinnytsia
country: Ukraine
facility: Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"
city: Zhytomyr
country: Ukraine
facility: Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: