Clinical trial NCT05156281: Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Official title: A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: MS
RMS
RRMS
active secondary progressive multiple sclerosis SPMS
remibrutinib
LOU064
teriflunomide
adult
relapse
Expanded Disability Status Scale
T2 lesions
T1 lesions
GD- enhancing MRI
Neurofilament light chain
McDonald diagnostic criteria
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomized in a 1:1 ratio
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Detailed description: The study CLOU064C12302 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.

The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).

The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.

A second study of identical design (CLOU064C12301) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.

Eligibility criteria: Inclusion Criteria:

* 18 to 55 years of age
* Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
* At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
* EDSS score of 0 to 5.5 (inclusive)
* Neurologically stable within 1 month

Exclusion Criteria:

* Diagnosis of primary progressive multiple sclerosis (PPMS)
* Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
* History of clinically significant CNS disease other than MS
* Ongoing substance abuse (drug or alcohol)
* History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
* suicidal ideation or behavior
* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
* Participants who have had a splenectomy
* Active clinically significant systemic bacterial, viral, parasitic or fungal infections
* Positive results for syphilis or tuberculosis testing
* Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
* Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
* Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
* History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepatic failure or any chronic liver or biliary disease.
* History of severe renal disease or creatinine level
* Participants at risk of developing or having reactivation of hepatitis
* Hematology parameters at screening:

  * Hemoglobin: \< 10 g/dl (\<100g/L)
  * Platelets: \< 100000/mm3 (\<100 x 109/L)
  * Absolute lymphocyte count \< 800/mm3 (\<0.8 x 109/L)
  * White blood cells: \<3 000/mm3 (\<3.0 x 109/L)
  * Neutrophils: \< 1 500/mm3 (\<1.5 x 109/L)
  * B-cell count \< 50% lower limit of normal (LLN) or total IgG \& total IgM \< LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
* History or current diagnosis of significant ECG abnormalities
* Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit
* Use of other investigational drugs
* Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,
* History of gastrointestinal bleeding
* Major surgery within 8 weeks prior to screening
* History of hypersensitivity to any of the study drugs or excipients
* Pregnant or nursing (lactating) female participants, prior to randomization
* Women of childbearing potential not using highly effective contraception
* Sexually active males not agreeing to use condom
* Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
* Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization

Inclusion to Extension part:

• Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Annualized relapse rate (ARR) of confirmed relapses [Core Part]
timeFrame: From Baseline, up to 30 months
Secondary outcomes:
measure: Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Annualized rate of new or enlarging T2 lesion [Core Part]
timeFrame: Baseline up to 30 months
measure: Neurofilament light chain (Nfl) [Core Part]
timeFrame: Baseline up to 30 months
measure: Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
timeFrame: Baseline up to 30 months
measure: Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Time to first confirmed relapse [Core Part]
timeFrame: Baseline up to 30 months
measure: Time to 6-month confirmed disability improvement (6mCDI) on EDSS [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Change from baseline in the Symbol Digit Modalities Test (SDMT) [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) [Core Part] (pooled data)
timeFrame: Baseline, up to 30 months
measure: Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Time to composite 6-month confirmed disability Progression (CDP) [Core Part] (pooled data)
timeFrame: Baseline up to 30 months
measure: Change from Baseline in T2 lesion volume [Core Part]
timeFrame: Baseline up to 30 months
measure: Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Core Part]
timeFrame: Baseline up to 30 months
measure: Number of participants with Adverse events and Serious adverse events(SAE) [Core Part]
timeFrame: Baseline up to 30 months
measure: Pharmacokinetics of remibrutinib [Core Part]
timeFrame: Month 1, Month 6
measure: Number of participants with Adverse events and Serious adverse events (SAE) [Extension Part]
timeFrame: Day 1 Extension up to 5 years
measure: Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
timeFrame: Day 1 Extension up to 5 years
measure: Annualized rate of new or enlarging T2 lesion [Extension Part]
timeFrame: Day 1 Extension up to 5 years
measure: Time to 6-month confirmed disability progression (6mCDP) on EDSS [Extension Part]
timeFrame: Day 1 Extension up to 5 years
measure: Change from baseline in the Symbol Digit Modalities Test (SDMT) [Extension Part]
timeFrame: Day 1 Extension up to 5 years
measure: Neurofilament light chain (NfL) [Extension Part]
timeFrame: Day 1 Extension up to 5 years
measure: Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) [Extension Part]
timeFrame: Day 1 Extension up to 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ctr for Neurology and Spine
state: Arizona
city: Hanford
country: United States
facility: Vladimir Royter MD APMC
state: California
city: Los Angeles
country: United States
facility: VA Greater LA Healthcare System
state: California
city: West Hollywood
country: United States
facility: Regina Berkovich MD PhD Inc
state: California
city: Aurora
country: United States
facility: CU Anschutz Med Campus
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Denver
country: United States
facility: Colorado Neurological Research PC
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital Research
state: District of Columbia
city: Boca Raton
country: United States
facility: SFM Clinical Research LLC
state: Florida
city: Bradenton
country: United States
facility: Nova Clinical Research LLC
state: Florida
city: Gainesville
country: United States
facility: Univ of Florida College of Medicine
state: Florida
city: Hollywood
country: United States
facility: Memorial Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Miami
country: United States
facility: Gables Neurology
state: Florida
city: Miami
country: United States
facility: UM Department Of Neurology
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Pembroke Pines
country: United States
facility: Humanity Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Neurology
state: Florida
city: Port Orange
country: United States
facility: Brain and Spine Institute
state: Florida
city: Vero Beach
country: United States
facility: Vero Beach Neurology
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Suwanee
country: United States
facility: Georgia Neurology and Sleep Medicine Assoc
state: Georgia
city: Merrillville
country: United States
facility: Methodist Neuroscience Institute
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Nicholasville
country: United States
facility: Baptist Physicians Lexington
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Frederick
country: United States
facility: Comprehensive Neurology
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Owosso
country: United States
facility: Memorial Healthcare
state: Michigan
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Patchogue
country: United States
facility: South Shore Neurologic Associates
state: New York
city: Port Jefferson Station
country: United States
facility: True North Neurology
state: New York
city: Chapel Hill
country: United States
facility: University Of NC At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Piedmont HealthCare
state: North Carolina
city: Columbus
country: United States
facility: The Boster Ctr for MS
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics Inc
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Uni of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Premier Neurology
state: South Carolina
city: Indian Land
country: United States
facility: Metrolina Neurological Associates PA
state: South Carolina
city: Knoxville
country: United States
facility: Sibyl Wray MD Neurology PC
state: Tennessee
city: Dallas
country: United States
facility: Neurology Consultants Of Dallas PA
state: Texas
city: El Paso
country: United States
facility: Med Research Inc
state: Texas
city: Frisco
country: United States
facility: Lone Star Neurology
state: Texas
city: Houston
country: United States
facility: Neurocare Plus
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
city: San Antonio
country: United States
facility: Lonestar Neurology of San Antonio
state: Texas
city: Sherman
country: United States
facility: Texas Institute for Neurological Disorders
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Centre
state: Washington
city: Seattle
country: United States
facility: University of Washington MS Clinic
state: Washington
city: Crab Orchard
country: United States
facility: Elligo Health Research
state: West Virginia
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Ascension St Francis Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Bombal
country: Argentina
facility: Novartis Investigative Site
state: Mendoza
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel De
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Brasilia
country: Brazil
facility: Novartis Investigative Site
state: DF
city: Vitoria
country: Brazil
facility: Novartis Investigative Site
state: ES
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Joinville
country: Brazil
facility: Novartis Investigative Site
state: Santa Catarina
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Burnaby
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Levis
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St Jerome
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Fuzhou
country: China
facility: Novartis Investigative Site
state: Fujian
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Yinchuan
country: China
facility: Novartis Investigative Site
state: Ningxia
city: Taiyuan
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Split
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Varazdin
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Vukovar
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Limoges
country: France
facility: Novartis Investigative Site
state: Haute Vienne
city: Toulon Cedex 9
country: France
facility: Novartis Investigative Site
state: Val De Marne
city: Caen
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand Cedex 1
country: France
facility: Novartis Investigative Site
city: Contamine Sur Arve
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Gonesse
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Poissy
country: France
facility: Novartis Investigative Site
city: Suresnes
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Chaidari
country: Greece
facility: Novartis Investigative Site
state: Attiki
city: Ioannina
country: Greece
facility: Novartis Investigative Site
state: GR
city: Larissa
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Greece
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Amritsar
country: India
facility: Novartis Investigative Site
state: Punjab
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Brindisi
country: Italy
facility: Novartis Investigative Site
state: BR
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Baggiovara
country: Italy
facility: Novartis Investigative Site
state: MO
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Ichihara
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Koriyama city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Isehara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Higashimatsuyama
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kodaira
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiba
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kobe shi
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Niigata
country: Japan
facility: Novartis Investigative Site
city: Ciudad de Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Chihuahua
country: Mexico
facility: Novartis Investigative Site
city: Ciudad De Mexico
country: Mexico
facility: Novartis Investigative Site
city: Queretaro
country: Mexico
facility: Novartis Investigative Site
city: Plewiska
country: Poland
facility: Novartis Investigative Site
state: Poznan
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Glogow
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Zabrze
country: Poland
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Leiria
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Matosinhos
country: Portugal
facility: Novartis Investigative Site
city: Santa Maria da Feira
country: Portugal
facility: Novartis Investigative Site
city: Guaynabo
country: Puerto Rico
facility: Caribbean Center for Clinical Research, Inc
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
state: Mures
city: Brasov
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Constanta
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Campulung Muscel
country: Romania
facility: Novartis Investigative Site
city: Constanta
country: Romania
facility: Novartis Investigative Site
city: Suceava
country: Romania
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Celje
country: Slovenia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
state: Free State
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Rosebank
country: South Africa
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Gijon
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Albacete
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Lerida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Logrono
country: Spain
facility: Novartis Investigative Site
state: La Rioja
city: Pozuelo de Alarcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Torrejon de Ardoz
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Vitoria Gasteiz
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Sancaktepe
country: Turkey
facility: Novartis Investigative Site
state: Istanbul
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Meram
country: Turkey
facility: Novartis Investigative Site
city: Pendik Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Samsun
country: Turkey
facility: Novartis Investigative Site
city: Inverness
country: United Kingdom
facility: Novartis Investigative Site
state: Invernesshire
city: Canterbury
country: United Kingdom
facility: Novartis Investigative Site
state: Kent
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: