Clinical trial NCT05147220: 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: 2021-12-07
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 CLOU064C12301 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 (CLOU064C12302) 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: AZ Integrated Neuro and Spine
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Fort Smith
country: United States
facility: The Belinga Clinic
state: Arkansas
city: Berkeley
country: United States
facility: The Research and Education Inst. of Alta Bates Summit Med. Grp
state: California
city: Chula Vista
country: United States
facility: The Neuron Clinic
state: California
city: Fullerton
country: United States
facility: Neur Ctr of N Orange County
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Health System
state: California
city: Pasadena
country: United States
facility: SC3 Research Pasadena
state: California
city: Pomona
country: United States
facility: Neuro Center
state: California
city: Basalt
country: United States
facility: Mountain Neuro Research Center PC
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Neurology of Central FL Res Ctr
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Homestead
country: United States
facility: Homestead Assoc In Research Inc
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Miami
country: United States
facility: US Associates in Research
state: Florida
city: Orlando
country: United States
facility: Neurological Services of Orlando PA
state: Florida
city: Orlando
country: United States
facility: Orlando Health Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Comprehensive Neurology Clinic
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc
state: Florida
city: Seminole
country: United States
facility: Accel Research Sites St Pete-Largo
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience LLC
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Insight Hospital and Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Medical Group
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Fort Wayne
country: United States
facility: IU Health Inc
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Louisville
country: United States
facility: Norton Neurology MS Services
state: Kentucky
city: Bethesda
country: United States
facility: Mid Atlantic Epilepsy and Sleep Ctr
state: Maryland
city: Lutherville
country: United States
facility: International Neurorehab Institute
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Cente
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England PC
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University Multiple Sclerosis Clinic
state: Michigan
city: Saint Louis
country: United States
facility: The MS Center for Innovation in Care
state: Missouri
city: Billings
country: United States
facility: SCL Health
state: Montana
city: Neptune
country: United States
facility: Jersey Shore University Medical Ctr
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Health
state: New York
city: Lake Success
country: United States
facility: Neurological Associates of Long Island PC
state: New York
city: New York
country: United States
facility: NYU Langone Med Center CV Research
state: New York
city: Charlotte
country: United States
facility: The Neurological Institute PA
state: North Carolina
city: Raleigh
country: United States
facility: Velocity Clinical Research
state: North Carolina
city: Westerville
country: United States
facility: Columbus Neuroscience
state: Ohio
city: Oklahoma City
country: United States
facility: Multiple Sclerosis Center of Excellence of OMRF
state: Oklahoma
city: Portland
country: United States
facility: Providence St Vincent Med Center
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Of Pittsburgh Medical Ctr Magee-Womens Hospital
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Dallas
country: United States
facility: Texas Neurology
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwest Med Center
state: Texas
city: El Paso
country: United States
facility: Advc Neurology Epilepsy and Sleep
state: Texas
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
city: Houston
country: United States
facility: Neuro Eye Clinical Trials Inc
state: Texas
city: McAllen
country: United States
facility: DHR Health Institute
state: Texas
city: Plano
country: United States
facility: North TX Inst of Neuro and Headache
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Vienna
country: United States
facility: MS Center of Greater Washington, P.C.
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Neenah
country: United States
facility: Neuroscience Group
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
city: Santiago del Estero
country: Argentina
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
state: Oberoesterreich
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Klagenfurt
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Ath
country: Belgium
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Lier
country: Belgium
facility: Novartis Investigative Site
city: Melsbroek
country: Belgium
facility: Novartis Investigative Site
city: Pelt
country: Belgium
facility: Novartis Investigative Site
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Porto Alegre RS
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
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: Santiago
country: Chile
facility: Novartis Investigative Site
state: Region Metropolitana
city: Santiago
country: Chile
facility: Novartis Investigative Site
state: Region Metropolitana
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Zhengzhou
country: China
facility: Novartis Investigative Site
state: Henan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Baotou
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Hohhot
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Chang Chun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Puerto Colombia
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Cali
country: Colombia
facility: Novartis Investigative Site
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Novartis Investigative Site
state: Valle Del Cauca
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Medellin
country: Colombia
facility: Novartis Investigative Site
city: Medellin
country: Colombia
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Osijek
country: Croatia
facility: Novartis Investigative Site
city: Zadar
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Slagelse
country: Denmark
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Tbilisi
country: Georgia
facility: Novartis Investigative Site
city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
city: Sha Tin
country: Hong Kong
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Mangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nashik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nasik
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Chandigarh
country: India
facility: Novartis Investigative Site
state: Punjab
city: Ludhiana
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: Dehradun
country: India
facility: Novartis Investigative Site
state: Uttarakhand
city: Mangalore
country: India
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Hadera
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Sefad
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Montichiari
country: Italy
facility: Novartis Investigative Site
state: BS
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Novara
country: Italy
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: El Chouf
country: Lebanon
facility: Novartis Investigative Site
state: LBN
city: Ashrafieh
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Tripoli
country: Lebanon
facility: Novartis Investigative Site
city: Siauliai
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Seberang Jaya
country: Malaysia
facility: Novartis Investigative Site
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kuala Terengganu
country: Malaysia
facility: Novartis Investigative Site
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: Wilayah Persekutuan
city: Zapopan
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: San Pedro Garza Garcia
country: Mexico
facility: Novartis Investigative Site
city: Veracruz
country: Mexico
facility: Novartis Investigative Site
city: Den Bosch
country: Netherlands
facility: Novartis Investigative Site
city: Dordrecht
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
state: Woj Kujawsko-pomorskie
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Piotrkow Trybunalski
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Szczecin
country: Poland
facility: Novartis Investigative Site
city: Khorais Street
country: Saudi Arabia
facility: Novartis Investigative Site
state: Riyadh
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
city: Cadiz
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sant Joan Despi
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Alcorcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Getafe
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: Castilleja De La Cuesta
country: Spain
facility: Novartis Investigative Site
state: Sevilla
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Leon
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
state: Cankaya
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Haseki Istanbul
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: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Westbruy On Trym
country: United Kingdom
facility: Novartis Investigative Site
state: Bristol
city: Winchester
country: United Kingdom
facility: Novartis Investigative Site
state: Hampshire
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: