Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

ClinicalTrials.gov Identifier: NCT04179175

Novartis Reference Number: CAIN457M2301E1

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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 extension study is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT 0313632) and AIN567M2302 (NCT03713619).

Condition 
Hidradenitis Suppurativa
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
745 participants
Start date 
Mar 18, 2020
Completion date 
Feb 18, 2026
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
subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2

Exclusion Criteria:

protocol deviation in the core study which will prevent the meaningful analysis of the extension study
ongoing or planned use of prohibited HS or non-HS treatment
participation in the extension could expose the subject to an undue safety risk
current sever progressive or uncontrolled disease which renders the subject unsuitable for the study.

Study Locations

United States
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Rogers, 72758
Arkansas
United States
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San Diego, 92103
California
United States
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Whittier, 92677
California
United States
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Tampa, 33612
Florida
United States
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Sandy Springs, 30328
Georgia
United States
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West Dundee, 60118
Illinois
United States
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Indianapolis, 46256
Indiana
United States
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Boston, 02215
Massachusetts
United States
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New Brighton, 55112
Minnesota
United States
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Omaha, 68144
Nebraska
United States
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New York, 10029
New York
United States
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Chapel Hill, 27516
North Carolina
United States
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Pittsburgh, 15213-3403
Pennsylvania
United States
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Charleston, 29407
South Carolina
United States
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Dallas, 75246-1613
Texas
United States
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Pflugerville, 78660
Texas
United States
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San Antonio, 78229
Texas
United States
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Norfolk, 23507
Virginia
United States
Australia
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Phillip, 2606
Australian Capital Territory
Australia
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East Melbourne, 3002
Victoria
Australia
Austria
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Linz, 4020
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Austria
Belgium
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Bruxelles, 1070
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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, 1407
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Bulgaria
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Sofia, 1606
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Bulgaria
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Stara Zagora, 6000
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Bulgaria
Canada
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Barrie, L4M 7G1
Ontario
Canada
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London, N6H 5L5
Ontario
Canada
Czechia
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Usti nad Labem, 400 11
Czech Republic
Czechia
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Prague, 11000
Prague 1
Czechia
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JIhlava, 586 01
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Czechia
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Plzen, 30460
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Czechia
France
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Limoges cedex, 87000
Haute Vienne
France
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Brest, 29609
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France
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Lyon, 69437
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France
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Nantes Cedex 1, 44093
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France
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Nice, 06202
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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
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Toulouse Cedex, 31400
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France
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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Bielefeld, 33647
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Germany
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Bochum, 44791
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Germany
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Dessau Rosslau, 06847
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Germany
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Frankfurt, 60590
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Germany
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Halle (Saale), 06108
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Germany
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Hamburg, 20246
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Germany
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Heidelberg, 69120
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Germany
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Langenau, 89129
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Germany
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Memmingen, 87700
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Germany
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Muenchen, 81377
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Germany
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Potsdam, 14467
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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
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Athens, 12462
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Greece
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Athens, 161 21
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Hungary
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Budapest, 1085
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Hungary
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Kaposvar, 7400
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Hungary
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Pecs, 7632
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India
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Mysore, 570001
Karnataka
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Israel
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Jerusalem, 91120
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Israel
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Petach Tikva, 49100
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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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Napoli, 80131
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Japan
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Kisarazu, 292-8535
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Nakagami, 903 0215
Okinawa
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Koshigaya-city, 343-8555
Saitama
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Itabashi-ku, 173-8610
Tokyo
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Korea, Republic of
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Seoul, 02841
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Seoul, 03080
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Korea, Republic of
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Seoul, 07441
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Korea, Republic of
Lithuania
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Kaunas, LT 50161
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Lithuania
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Vilnius, LT 08411
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Poland
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Warszawa, 02 495
Mazowian
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Lodz, 90-436
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Ossy, 42 624
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Rzeszow, 35 055
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Poland
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Warszawa, 04141
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Poland
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Wroclaw, 50 566
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Portugal
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Lisboa, 1150 314
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Portugal
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Lisboa, 1998-018
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Portugal
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Porto, 4099-001
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Portugal
Russian Federation
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Chelyabinsk, 454092
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Russian Federation
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Kazan, 420012
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Russian Federation
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Krasnodar, 350020
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Russian Federation
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Saint Petersburg, 191123
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Russian Federation
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Saint Petersburg, 197022
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Russian Federation
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Smolensk, 214031
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Russian Federation
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Yaroslavl, 150003
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Russian Federation
Singapore
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Singapore, 119074
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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
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Kosice, 04001
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Slovakia
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Presov, 081 81
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Slovakia
South Africa
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Pretoria, 0001
Gauteng
South Africa
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Soweto, 2013
Gauteng
South Africa
Spain
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Cadiz, 11009
Andalucia
Spain
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Barcelona, 08003
Catalunya
Spain
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Manises, 46940
Valencia
Spain
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Barcelona, 08041
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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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Madrid, 28009
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Spain
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Pontevedra, 36003
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Switzerland
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Bern, 3010
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Switzerland
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Taipei, 10002
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Taiwan
Turkey
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Istanbul, 34098
TUR
Turkey
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Altunizade, 34662
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Turkey
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Antalya, 07070
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Talas / Kayseri, 38039
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United Kingdom
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Salford, M6 8HD
Manchester
United Kingdom
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Dudley, DY1 2HQ
West Midlands
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Bradford, BD5 0NA
West Yorkshire
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Exeter, EX2 5DW
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Harrogate, HG2 7SX
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Norwich, NR4 7UY
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Phone: 
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Name: 
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