Clinical trial NCT05852938: A Study of Zigakibart in Adults With IgA Nephropathy
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: IgA Nephropathy
Immunoglobulin A Nephropathy
Keywords: Kidney Diseases
Kidney Diseases, Chronic
Urological Diseases
Glomerulonephritis
Glomerular Disease
Glomerulonephritis, IGA
Glomerulopathy
Immunoglobulin Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Detailed description: Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m\^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to \< 30 mL/min/1.73 m\^2. The exploratory cohort will be randomized using the same schema as the primary cohort.

The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy.

Participants will have assessments of safety and efficacy for up to 2.5 years (134 weeks). To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.

Eligibility criteria: Inclusion Criteria:

* Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
* eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
* Screening weight of 45 to 150 kg.
* Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group \[CTFG\] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated \> 1 month prior to first dose of study drug.
* Provide written informed consent and be willing to comply with study visits and procedures.

Exclusion Criteria:

* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Average blood pressure \> 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator.
* Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines
* Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN.
* History of Type 1 Diabetes.
* Participants with Type 2 diabetes are excluded if any of the following are present:

  * Screening HbA1c (glycated hemoglobin) of \> 8%.
  * Evidence of diabetic changes on kidney biopsy, performed for any reason.
  * History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease).
  * Unstable anti-diabetic regimen:
* Prior exposure to any therapy directed against APRIL.
* History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody.
* Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants.
* Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator.
* Positive serology test for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening.
* Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug.
* History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are allowed.
* Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
* History or evidence of any other clinically significant disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results.
* IgG levels \< 6 g/L at Screening.
* Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.

Primary outcomes:
measure: Change in proteinuria (natural log UPCR)
timeFrame: 40 weeks or approximately 9 months
Secondary outcomes:
measure: Annualized rate of change in eGFR
timeFrame: 104 weeks or approximately 2 years
measure: Change from baseline in eGFR
timeFrame: 104 weeks or approximately 2 years
measure: Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)
timeFrame: Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
measure: Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)
timeFrame: Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
measure: Percent Change in Proteinuria and Total Urine Protein
timeFrame: 40 weeks or approximately 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham: The Kirklin Clinic
state: Alabama
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Glendale
country: United States
facility: Kidney Disease Medical Group Inc-1500 S Central Ave
state: California
city: Huntington Park
country: United States
facility: IMD Clinical Trials
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: South Gate
country: United States
facility: Valiance Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Nephrology Research Division
state: Colorado
city: Pembroke Pines
country: United States
facility: Vida Medical Centers - Pembroke Pines
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Hinsdale
country: United States
facility: Nephrology Associales of Northern Illinois and Indiana
state: Illinois
city: Fort Wayne
country: United States
facility: Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Edina
country: United States
facility: Intermed Consultants
state: Minnesota
city: Clifton Park
country: United States
facility: Capital District Renal Physicians
state: New York
city: Flushing
country: United States
facility: Nephrology Associates PC - Flushing
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine - 231 Albert Sabin Way
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic-9500 Euclid Ave
state: Ohio
city: Portland
country: United States
facility: OHSU - Oregon Clinical and Translational Research Institute
state: Oregon
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center, LLC
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Nephrology Associates , P.A. - Columbia
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC - Frenova F1
state: Tennessee
city: Dallas
country: United States
facility: Dallas Renal Group - 1411 N Beckley Ave
state: Texas
city: Dallas
country: United States
facility: Dallas Renal Group - Waxachie - 2460 N. I-35
state: Texas
city: El Paso
country: United States
facility: DaVita Clinical Research
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center-1155 Pressler
state: Texas
city: Lufkin
country: United States
facility: East Texas Nephrology Associates
state: Texas
city: Fairfax
country: United States
facility: Nephrology Associates of Northern Virginia-8501 Arlington Blvd
state: Virginia
city: Seattle
country: United States
facility: Swedish Center for Comprehensive Care
state: Washington
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: San Fernando del Valle de Catamarca
country: Argentina
facility: Novartis Investigative Site
state: Catamarca
city: Barracas
country: Argentina
facility: Novartis Investigative Site
state: Ciudad Autónoma de BuenosAires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Gosford
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Penrith
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: St Leonards
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Cairns North
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: St Albans
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
state: Antwerpen
city: Gent
country: Belgium
facility: Novartis Investigative Site
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
state: West-Vlaanderen
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Lodelinsart
country: Belgium
facility: Novartis Investigative Site
city: Woluwe-Saint-Lambert
country: Belgium
facility: Novartis Investigative Site
city: Santana
country: Brazil
facility: Novartis Investigative Site
state: Amapá
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: Minas Gerais
city: Maringa
country: Brazil
facility: Novartis Investigative Site
state: Parana
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande do Sul
city: Joinville
country: Brazil
facility: Novartis Investigative Site
state: Santa Catarina
city: São Bernardo Do Campo
country: Brazil
facility: Novartis Investigative Site
state: São Paulo
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: East York
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Foshan
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shenzhen
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Nanning
country: China
facility: Novartis Investigative Site
state: Guangxi
city: Guiyang
country: China
facility: Novartis Investigative Site
state: Guizhou
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nantong
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Wuxi
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Jinan
country: China
facility: Novartis Investigative Site
state: Shandong
city: Qingdao
country: China
facility: Novartis Investigative Site
state: Shandong
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Taiyuan
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Taiyuan
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Urumqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Wulumuji
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Taizhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
state: Grad Zagreb
city: Biškupec Zelinski
country: Croatia
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
city: Vinkovci
country: Croatia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
state: Praha, hlavní mesto
city: Nîmes
country: France
facility: Novartis Investigative Site
state: Gard
city: Lille
country: France
facility: Novartis Investigative Site
state: Nord
city: Lyon
country: France
facility: Novartis Investigative Site
state: Rhône
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Mainz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Jena
country: Germany
facility: Novartis Investigative Site
state: Thüringen
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Patras
country: Greece
facility: Novartis Investigative Site
state: Achaïa
city: Athens
country: Greece
facility: Novartis Investigative Site
state: Attiki
city: Kalamaria
country: Greece
facility: Novartis Investigative Site
state: Thessaloniki
city: Heralkion
country: Greece
facility: Novartis Investigative Site
city: Ioannina
country: Greece
facility: Novartis Investigative Site
city: Ioannina
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Faridabad
country: India
facility: Novartis Investigative Site
state: Haryana
city: Bengaluru
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Trivandrum
country: India
facility: Novartis Investigative Site
state: Kerala
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Vellore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Chandigarh
country: India
facility: Novartis Investigative Site
city: Dehradun
country: India
facility: Novartis Investigative Site
city: Be'er Sheva
country: Israel
facility: Novartis Investigative Site
state: HaDarom
city: Holon
country: Israel
facility: Novartis Investigative Site
state: Tel-Aviv
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
state: Tel-Aviv
city: Be'er Ya'akov
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
state: Campania
city: Modena
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: Friuli-Venezia Giulia
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Ranica
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Bari
country: Italy
facility: Novartis Investigative Site
state: Puglia
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: Puglia
city: Kasugai-Shi
country: Japan
facility: Novartis Investigative Site
state: Aiti
city: Toyoake-shi
country: Japan
facility: Novartis Investigative Site
state: Aiti
city: Sapporo-shi
country: Japan
facility: Novartis Investigative Site
state: Hokkaidô
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Hukuoka
city: Yokohama-Shi
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kashihara
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Nara-Shi
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Osaka-Shi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Urayasu-Shi
country: Japan
facility: Novartis Investigative Site
state: Tiba
city: Bunkyo-Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-Shi
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-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: Niigata
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Yufu-Shi
country: Japan
facility: Novartis Investigative Site
state: Ôita
city: Dongan-Gu, Anyang-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggido
city: Guri-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggido
city: Uijeongbu-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggido
city: Jongno-gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seoul Teugbyeolsi
city: Seodaemun-gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seoul Teugbyeolsi
city: Seongbuk-Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seoul Teugbyeolsi
city: Cheonan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Kuantan
country: Malaysia
facility: Novartis Investigative Site
state: Pahang
city: Sibu
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kajang
country: Malaysia
facility: Novartis Investigative Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: WilayahPersekutuan KualaLumpur
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
state: WilayahPersekutuan KualaLumpur
city: Chihuahua
country: Mexico
facility: Novartis Investigative Site
state: Chiapas
city: Barrio Belisario Domínguez Secc
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Oaxaca
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: Chihuahua
country: Mexico
facility: Novartis Investigative Site
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
city: Manises
country: Spain
facility: Novartis Investigative Site
state: Valencia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Girona
country: Spain
facility: Novartis Investigative Site
city: Lleida
country: Spain
facility: Novartis Investigative Site
city: Lugo
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Changhua County
country: Taiwan
facility: Novartis Investigative Site
city: Hsinchu City
country: Taiwan
facility: Novartis Investigative Site
city: Hualien City
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Keelung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei City
country: Taiwan
facility: Novartis Investigative Site
city: Taipei city
country: Taiwan
facility: Novartis Investigative Site
city: Bornova
country: Turkey
facility: Novartis Investigative Site
state: Izmir
city: İzmit
country: Turkey
facility: Novartis Investigative Site
state: Kocaeli
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
state: Bristol, City of
city: Brighton
country: United Kingdom
facility: Novartis Investigative Site
state: East Sussex
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
state: Lancashire
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
state: Leicestershire
city: London
country: United Kingdom
facility: Novartis Investigative Site
state: London, City of
city: London
country: United Kingdom
facility: Novartis Investigative Site
state: London, City of
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
state: Nottinghamshire
Study officials:
References: