Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis

A Randomized, Multicenter STudy to Evaluate the Effect of Secukinumab 300 mg s.c. Administered During 52 Weeks to Patients Suffering From New-onset Moderate to Severe Plaque Psoriasis as Early Intervention Compared to Standard Treatment With Narrow-band UVB (STEPIn Study)

ClinicalTrials.gov Identifier: NCT03020199

Novartis Reference Number: CAIN457A2322

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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 determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe plaque psoriasis may lead to prolonged symptom free periods by preventing reactivation of old lesions or ultimately totally hindering the occurrence of new lesions, i.e., changing the natural course of the disease (Main Study).

Condition 
Plaque Psoriasis
Phase 
Phase 4
Overall status 
Active, not recruiting
Enrollment count 
196 participants
Start date 
Mar 27, 2017
Completion date 
Aug 30, 2024
Gender 
All
Age(s)
18 Years - 50 Years (Adult)

Interventions

Biological
Secukinumab
Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL.
Radiation
nbUVB
Narrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application will be performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face is recommended
Biological
Secukinumab
Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
Biological
Secukinumab
Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
Biological
Secukinumab
Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
Drug
Calcipotriol
Its a topical treatment for Psoriasis. the concentration it is used is 50mcg/g
Drug
Betamethasone
this is topical cream which is used in 0.5mg/g concentration

Eligibility Criteria

Inclusion Criteria:

Able to understand and communicate with the investigator, willing and capable to comply with all study procedures, and provide written signed and dated informed consent (personally or by a witness) before any assessment is performed
Aged 18 to 40 years inclusive
New-onset plaque psoriasis with appearance of the first psoriasis plaques within the last 12 months before randomization and naïve to any systemic treatment and phototherapy (Arms A1, A2 and Arm B1)
Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years or longer and intolerance or inadequate response to phototherapy or any systemic treatment including biologicals, except for IL-17A inhibitors (Arm C1 and Arm C2)
Moderate to severe plaque psoriasis defined at screening and baseline by PASI ≥ 10, and body surface area (BSA) ≥ 10%, and investigator's global assessment (IGA mod 2011) ≥ 3

Exclusion Criteria:

Forms of psoriasis other than plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, and drug induced)
Ongoing use of prohibited treatments
Previous treatment with phototherapy or any systemic treatment
Pregnant or nursing (lactating) women
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the Treatment Epoch or longer if required by locally-approved prescribing information (e.g., 20 weeks in the EU)

Study Locations

Argentina
Novartis Investigative Site
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Ciudad Autonoma de Bs As, 1181
Buenos Aires
Argentina
Novartis Investigative Site
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Buenos Aires, C1425DKG
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Argentina
Bulgaria
Novartis Investigative Site
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Pleven, 5800
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Bulgaria
Novartis Investigative Site
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Plovdiv, 4002
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Bulgaria
Novartis Investigative Site
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Sofia, 1407
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Bulgaria
Novartis Investigative Site
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Sofia, 1632
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Bulgaria
Canada
Novartis Investigative Site
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Markham, L3P 1X2
Ontario
Canada
Novartis Investigative Site
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Sudbury, P3C 1X8
Ontario
Canada
Denmark
Novartis Investigative Site
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Aarhus, 8000
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Denmark
Estonia
Novartis Investigative Site
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Tallinn, 10138
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Estonia
Novartis Investigative Site
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Tallinn, 13419
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Estonia
Novartis Investigative Site
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Tartu, 51014
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Estonia
Finland
Novartis Investigative Site
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Tampere, 33100
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Finland
Novartis Investigative Site
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Turku, FIN-20100
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Finland
Germany
Novartis Investigative Site
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Bad Bentheim, 48455
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Germany
Novartis Investigative Site
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Berlin, 10789
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Germany
Novartis Investigative Site
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Berlin, 13353
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Germany
Novartis Investigative Site
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Erlangen, 91054
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Germany
Novartis Investigative Site
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Frankfurt, 60590
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Germany
Novartis Investigative Site
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Lubeck, 23538
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Germany
Novartis Investigative Site
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Potsdam, 14467
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Germany
Novartis Investigative Site
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Quedlinburg, 06484
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Germany
Hungary
Novartis Investigative Site
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Nyíregyháza, 4400
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Hungary
Novartis Investigative Site
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Szolnok, 5000
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Hungary
Poland
Novartis Investigative Site
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Bialystok, 15-879
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Poland
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Bydgoszcz, 85-094
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Poland
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Gdansk, 80 952
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Poland
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Gdansk, 80-803
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Poland
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Krakow, 31-070
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Poland
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Lodz, 90-436
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Poland
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Lodz, 90-647
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Poland
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Lublin, 20-079
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Poland
Spain
Novartis Investigative Site
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Barcelona, 08036
Cataluna
Spain
Novartis Investigative Site
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Alicante, 03010
Comunidad Valenciana
Spain
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Alcorcon, 28922
Madrid
Spain
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Barcelona, 08003
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Spain
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Barcelona, 08025
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Spain
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Las Palmas de Gran Canaria, 35010
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Spain
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Madird, 28041
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Spain
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Madrid, 28031
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Spain
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Valencia, 46014
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Spain
Sweden
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Goethenburg,
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Sweden
Novartis Investigative Site
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Malmo, 214 28
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Sweden
Switzerland
Novartis Investigative Site
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Lausanne, CH-1011
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Switzerland
United Kingdom
Novartis Investigative Site
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Bradford, BD5 0NA
West Yorkshire
United Kingdom
Novartis Investigative Site
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Leeds, LS7 4SA
West Yorkshire
United Kingdom
Novartis Investigative Site
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London, SE1 9RT
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United Kingdom
Novartis Investigative Site
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Salford, M6 8HD
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United Kingdom

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