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

A Randomized, Double-blind, Multi-center 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 (SUNSHINE).

ClinicalTrials.gov Identifier: NCT03713619

Novartis Reference Number: CAIN457M2301

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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 
Jan 31, 2019
Completion date 
May 25, 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
Birmingham, 35205
Alabama
United States
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Rogers, 72758
Arkansas
United States
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Anaheim, 92807
California
United States
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San Diego, 92123
California
United States
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Miami, 33125
Florida
United States
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Tampa, 33612
Florida
United States
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Skokie, 60077
Illinois
United States
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West Dundee, 60118
Illinois
United States
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Rockville, 20850
Maryland
United States
Novartis Investigative Site
Recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Completed
New Brighton, 55112
Minnesota
United States
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Recruiting
Saint Joseph, 64506
Missouri
United States
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Chapel Hill, 27516
North Carolina
United States
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Fairborn, 45324
Ohio
United States
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Philadelphia, 19107
Pennsylvania
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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Goodlettsville, 37072-2301
Tennessee
United States
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Dallas, 75246-1613
Texas
United States
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San Antonio, 78229
Texas
United States
Argentina
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Recruiting
Ciudad Autonoma de Bs As, C1425BEA
Buenos Aires
Argentina
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La Plata, B1902COS
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1425DKG
-
Argentina
Australia
Novartis Investigative Site
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Phillip, 2606
Australian Capital Territory
Australia
Novartis Investigative Site
Recruiting
Benowa, 4217
Queensland
Australia
Novartis Investigative Site
Recruiting
East Melbourne, 3002
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Linz, 4020
-
Austria
Novartis Investigative Site
Recruiting
Wien, A 1090
-
Austria
Belgium
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Bruxelles, 1070
Brussels
Belgium
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Bruxelles, 1200
-
Belgium
Bulgaria
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Sofia, 1606
-
Bulgaria
Novartis Investigative Site
Recruiting
Stara Zagora, 6000
-
Bulgaria
Canada
Novartis Investigative Site
Withdrawn
Fredericton, E3B 1G9
New Brunswick
Canada
Novartis Investigative Site
Recruiting
London, N6H 5L5
Ontario
Canada
Novartis Investigative Site
Recruiting
Peterborough, K9J 5K2
Ontario
Canada
Novartis Investigative Site
Recruiting
Waterloo, N2J 1C4
Ontario
Canada
Czechia
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Prague, 11000
Prague 1
Czechia
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Plzen, 30460
-
Czechia
France
Novartis Investigative Site
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Bordeaux Cedex, 33075
-
France
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Brest, 29609
-
France
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Creteil, 94010
-
France
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Lyon, 69437
-
France
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Montpellier cedex 5, 34295
-
France
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Nantes Cedex 1, 44093
-
France
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Paris Cedex 10, 75475
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France
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Toulouse Cedex, 31400
-
France
Germany
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Bielefeld, 33647
-
Germany
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Bochum, 44791
-
Germany
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Frankfurt, 60590
-
Germany
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Halle (Saale), 06108
-
Germany
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Langenau, 89129
-
Germany
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Memmingen, 87700
-
Germany
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Muenchen, 81675
-
Germany
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Potsdam, 14467
-
Germany
Greece
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Athens, 12462
-
Greece
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Thessaloniki, 546 43
-
Greece
Hungary
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Budapest, 1085
-
Hungary
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Pecs, 7632
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Hungary
India
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New Delhi, 110 060
Delhi
India
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Mangalore, 575002
Karnataka
India
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Mysore, 570001
Karnataka
India
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Nashik, 422 101
Maharashtra
India
Israel
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Jerusalem, 91120
-
Israel
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Petach Tikva, 49100
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Israel
Italy
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Firenze, 50122
FI
Italy
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Milano, 20122
MI
Italy
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Modena, 41124
MO
Italy
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Pisa, 56124
PI
Italy
Japan
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Nagoya-city, 467-8602
Aichi
Japan
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Kisarazu, 292-8535
Chiba
Japan
Novartis Investigative Site
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Nishinomiya-city, 663-8186
Hyogo
Japan
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Active, not recruiting
Nakagami, 903 0215
Okinawa
Japan
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Recruiting
Koshigaya-city, 343-8555
Saitama
Japan
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Shimotsuga Gun, 321-0293
Tochigi
Japan
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Itabashi-ku, 173-8610
Tokyo
Japan
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Osaka, 545-8586
-
Japan
Korea, Republic of
Novartis Investigative Site
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Seoul, 02841
-
Korea, Republic of
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Seoul, 03080
-
Korea, Republic of
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Seoul, 07441
-
Korea, Republic of
Mexico
Novartis Investigative Site
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Guadalajara, 44657
Jalisco
Mexico
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Monterrey, 64460
Nuevo Leon
Mexico
Philippines
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Davao City, 8000
Davao
Philippines
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Quezon City, 1104
Metro Manila
Philippines
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Las Pinas, 1740
-
Philippines
Poland
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Warszawa, 02 495
Mazowian
Poland
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Ossy, 42 624
-
Poland
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Wroclaw, 50 566
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Poland
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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Matosinhos, 4454 513
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Portugal
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Porto, 4099-001
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Portugal
Russian Federation
Novartis Investigative Site
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Kazan, 420012
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Russian Federation
Novartis Investigative Site
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Krasnodar, 350020
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Russian Federation
Novartis Investigative Site
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Saint Petersburg, 197022
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Russian Federation
Novartis Investigative Site
Active, not recruiting
Yaroslavl, 150003
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Russian Federation
Slovakia
Novartis Investigative Site
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Kosice, 4190
Slovak Republic
Slovakia
Novartis Investigative Site
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Martin, 03659
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Slovakia
Spain
Novartis Investigative Site
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Cadiz, 11009
Andalucia
Spain
Novartis Investigative Site
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Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
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Fuenlabrada, 28942
Madrid
Spain
Novartis Investigative Site
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Barcelona, 08041
-
Spain
Novartis Investigative Site
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Madrid, 28041
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Spain
Novartis Investigative Site
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Pontevedra, 36003
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Spain
Sweden
Novartis Investigative Site
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Uppsala, 751 85
-
Sweden
Switzerland
Novartis Investigative Site
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Bern, 3010
-
Switzerland
Novartis Investigative Site
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Geneve, 1205
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Switzerland
Taiwan
Novartis Investigative Site
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Taipei, 10002
-
Taiwan
Novartis Investigative Site
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Taoyuan, 33305
-
Taiwan
Turkey
Novartis Investigative Site
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Antalya, 07070
-
Turkey
Novartis Investigative Site
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Aydin, 09100
-
Turkey
Novartis Investigative Site
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Gaziantep, 27310
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Turkey
United Kingdom
Novartis Investigative Site
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Salford, M6 8HD
Manchester
United Kingdom
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Leeds, LS7 4SA
West Yorkshire
United Kingdom
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Barnsley, S75 2EP
-
United Kingdom
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Bristol, BS2 8HN
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United Kingdom
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Exeter, EX2 5DW
-
United Kingdom
Novartis Investigative Site
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Norwich, NR4 7UY
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United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
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Email: 

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