Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)

ClinicalTrials.gov Identifier: NCT03713632

Novartis Reference Number: CAIN457M2302

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

Condition 
Hidradenitis Suppurativa
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
541 participants
Start date 
Feb 25, 2019
Completion date 
Feb 16, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Secukinumab
Secukinumab 300mg every 2 or every 4 weeks

Eligibility Criteria

Inclusion Criteria:

-Written informed consent must be obtained before any assessment is performed.
Male and female patients ≥ 18 years of age.
Diagnosis of HS ≥ 1 year prior to baseline.
Patients with moderate to severe HS defined as:
A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND
Inflammatory lesions should affect at least 2 distinct anatomic areas
Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

Exclusion Criteria:

Total fistulae count ≥ 20 at baseline.
Any other active skin disease or condition that may interfere with assessment of HS.
Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.
Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
History of hypersensitivity to any of the study drug constituents.
History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
Pregnant or lactating women.

Study Locations

United States
Novartis Investigative Site
Recruiting
San Diego, 92103
California
United States
Novartis Investigative Site
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Whittier, 92677
California
United States
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Coral Gables, 33134
Florida
United States
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Tampa, 33609
Florida
United States
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Sandy Springs, 30328
Georgia
United States
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Indianapolis, 46256
Indiana
United States
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Boston, 02111
Massachusetts
United States
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Saint Louis, 63104
Missouri
United States
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Saint Louis, 63110
Missouri
United States
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Completed
Omaha, 68144
Nebraska
United States
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Recruiting
Bronx, 10461
New York
United States
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New York, 10029
New York
United States
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Portland, 97239
Oregon
United States
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Bellaire, 77401
Texas
United States
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Pflugerville, 78660
Texas
United States
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Norfolk, 23507
Virginia
United States
Argentina
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Caba, C1056ABJ
Buenos Aires
Argentina
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Rosario, S2000DBS
Santa Fe
Argentina
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Capital Federal, C1023AAB
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Argentina
Belgium
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Gent, 9000
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Belgium
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Liege, 4000
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Belgium
Bulgaria
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Pleven, 5800
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Bulgaria
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Sofia, 1431
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Bulgaria
Canada
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Barrie, L4M 7G1
Ontario
Canada
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Completed
Richmond Hill, L4C 9M7
Ontario
Canada
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Recruiting
Drummondville, J2B 5L4
Quebec
Canada
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Saint Jerome, J7Z 3B8
Quebec
Canada
Colombia
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Medellin, 05001000
Antioquia
Colombia
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Barranquilla,
Atlantico
Colombia
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Bogota, 110221
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Colombia
Croatia
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Zagreb, 10000
HRV
Croatia
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Osijek, 31000
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Croatia
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Zagreb, 10000
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Croatia
Czechia
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Usti nad Labem, 400 11
Czech Republic
Czechia
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Jihlava, 586 33
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Czechia
Denmark
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Aarhus, 8000
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Denmark
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Copenhagen NV, 2400
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Denmark
France
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Limoges cedex, 87000
Haute Vienne
France
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Toulon Cedex 9, 83800
Val De Marne
France
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Antony, 92160
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France
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Martigues, 13500
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France
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Nice, 06202
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France
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Reims, 51100
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France
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Rouen Cedex, 76031
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France
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Saint Mande, 94160
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France
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Saint-Etienne, 42055
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France
Germany
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Withdrawn
Augsburg, 86179
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Germany
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Berlin, 10789
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Germany
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Berlin, 13353
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Germany
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Dessau Rosslau, 06847
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Germany
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Erlangen, 91054
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Germany
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Hamburg, 20246
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Germany
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Withdrawn
Hamburg, 22391
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Germany
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Heidelberg, 69120
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Germany
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Muenchen, 81377
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Germany
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Muenster, 48149
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Germany
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Schwerin, 19055
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Germany
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Wuerzburg, 97080
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Germany
Greece
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Thessaloniki, 564 03
GR
Greece
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Athens, 161 21
-
Greece
Guatemala
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Guatemala City, 01010
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Guatemala
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Guatemala City, 01015
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Guatemala
Hungary
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Debrecen, 4032
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Hungary
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Kaposvar, 7400
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Hungary
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Szeged, 6725
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Hungary
India
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Mangalore, 575018
Karnataka
India
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Nagpur, 440009
Maharashtra
India
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Navi Mumbai, 400 706
Maharashtra
India
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Secunderabad, 500003
Telangana
India
Israel
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Ramat Gan, 52621
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Israel
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Tel Aviv, 6423906
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Israel
Italy
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Ancona, 60126
AN
Italy
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Cona, 44100
FE
Italy
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Roma, 00133
RM
Italy
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Napoli, 80131
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Italy
Lebanon
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Hazmieh, 470
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Lebanon
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Saida, 652
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Lebanon
Lithuania
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Kaunas, LT 50161
LTU
Lithuania
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Vilnius, LT 08411
Vilniaus
Lithuania
Malaysia
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Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
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Johor Bahru, 80100
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Malaysia
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Penang, 10990
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Malaysia
Netherlands
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Bergen op Zoom, 4624 VT
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Netherlands
Philippines
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Makati City, 1220
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Philippines
Poland
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Lodz, 90-436
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Poland
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Rzeszow, 35 055
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Poland
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Warszawa, 04141
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Poland
Russian Federation
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Chelyabinsk, 454092
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Russian Federation
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Saint Petersburg, 191123
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Russian Federation
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Smolensk, 214031
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Russian Federation
Singapore
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Singapore, 119074
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Singapore
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Singapore, 169608
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Singapore
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Singapore, 308205
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Singapore
Slovakia
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Banska Bystrica, 97401
Slovak Republic
Slovakia
Novartis Investigative Site
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Presov, 081 81
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Slovakia
South Africa
Novartis Investigative Site
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Pretoria, 0001
Gauteng
South Africa
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Soweto, 2013
Gauteng
South Africa
Spain
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Barcelona, 08003
Catalunya
Spain
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Manises, 46940
Valencia
Spain
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Granada, 18012
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Spain
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Las Palmas de Gran Canaria, 35010
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Spain
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Madrid, 28006
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Spain
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Madrid, 28009
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Spain
Switzerland
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Lausanne, 1011
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Switzerland
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Zurich, CH-8091
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Switzerland
Turkey
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Istanbul, 34098
TUR
Turkey
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Altunizade, 34662
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Turkey
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Izmir, 35040
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Turkey
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Talas / Kayseri, 38039
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Turkey
United Kingdom
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Dudley, DY1 2HQ
West Midlands
United Kingdom
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Bradford, BD5 0NA
West Yorkshire
United Kingdom
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Birmingham, B15 2TH
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United Kingdom
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Harrogate, HG2 7SX
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United Kingdom
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London, E1 1BB
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United Kingdom
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London, SE1 9RT
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United Kingdom
Vietnam
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Hanoi, 100000
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Vietnam
Novartis Investigative Site
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Ho Chi Minh, 7000
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Vietnam

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Phone: 
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Name: 
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Phone: 
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