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

Last updated: January 6, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Psoriasis And Psoriatic Disorders

Warts

Rosacea

Treatment

Betamethasone

Calcipotriol

nbUVB

Clinical Study ID

NCT03020199
CAIN457A2322
2015-002423-26
  • Ages 18-50
  • All Genders

Study Summary

The purpose of this study was 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Able to understand and communicate with the investigator, willing and capable tocomply with all study procedures, and provide written signed and dated informedconsent (personally or by a witness) before any assessment is performed.

  • Aged 18 to 50 years inclusive.

  • New-onset plaque psoriasis with appearance of the first psoriasis plaques within thelast 12 months before randomization and naïve to any systemic treatment andphototherapy (Arm A1, Arm A2, and Arm B1). Episodes of mild psoriasis, whichoccurred at least 3 years before screening and resolved spontaneously within 6months will be accepted.

  • Chronic plaque psoriasis with appearance of the first psoriasis symptoms 5 years orlonger and intolerance or inadequate response to phototherapy or any systemictreatment 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 IGA mod 2011 >= 3.

Exclusion

Key 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 ofbecoming pregnant, unless they are using effective methods of contraception duringthe Treatment period or longer if required by locally approved prescribinginformation (e.g., 20 weeks in the EU and countries where applicable forsecukinumab).

Study Design

Total Participants: 196
Treatment Group(s): 5
Primary Treatment: Betamethasone
Phase: 4
Study Start date:
March 27, 2017
Estimated Completion Date:
June 16, 2023

Study Description

This was and open label, parallel group, multicenter, randomized study with 3 clinical periods: Screening period, Treatment period, and Follow-up period.

The design consisted of the Main Study and a Mechanistic Sub study:

  1. The Main Study had 2-treatment-arm secukinumab and nb-UVB).

  2. The Mechanistic Sub-study had 4 arms treated with secukinumab and one arm with nb-UVB arm. The outcome measures were all exploratory, i.e. no results presented. Not all participants of the Mechanistic Sub-study participated in the Main Study, these participants are only reported for the safety analyses, but not for the primary and secondary outcome measures.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires 1181
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1425DKG
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Novartis Investigative Site

    Halifax, Nova Scotia B3H 1Z2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Sudbury, Ontario P3C 1X8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Brno, 656 91
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Aarhus, 8000
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Aarhus N, 8200
    Denmark

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  • Novartis Investigative Site

    Hellerup, 2900
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Tallinn, 10138
    Estonia

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  • Novartis Investigative Site

    Tartu, 50406
    Estonia

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  • Novartis Investigative Site

    Tampere, 33100
    Finland

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  • Novartis Investigative Site

    Turku, FIN-20100
    Finland

    Site Not Available

  • Novartis Investigative Site

    Bad Bentheim, 48455
    Germany

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  • Novartis Investigative Site

    Berlin, 10789
    Germany

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  • Novartis Investigative Site

    Erlangen, 91054
    Germany

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  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

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  • Novartis Investigative Site

    Lubeck, 23538
    Germany

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  • Novartis Investigative Site

    Luebeck, 23538
    Germany

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  • Novartis Investigative Site

    Potsdam, 14467
    Germany

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  • Novartis Investigative Site

    Quedlinburg, 06484
    Germany

    Site Not Available

  • Novartis Investigative Site

    Budapest, 1137
    Hungary

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  • Novartis Investigative Site

    Gyor, H-9023
    Hungary

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  • Novartis Investigative Site

    Nyiregyhaza, 4400
    Hungary

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  • Novartis Investigative Site

    Nyíregyháza, 4400
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szolnok, 5000
    Hungary

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  • Novartis Investigative Site

    Bergen, NO-5021
    Norway

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  • Novartis Investigative Site

    Oslo, N-0372
    Norway

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  • Novartis Investigative Site

    Tromsø, N-9038
    Norway

    Site Not Available

  • Novartis Investigative Site

    Trondheim, N-7006
    Norway

    Site Not Available

  • Novartis Investigative Site

    Bialystok, 15-879
    Poland

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  • Novartis Investigative Site

    Bia¿ystok, 15-879
    Poland

    Site Not Available

  • Novartis Investigative Site

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Novartis Investigative Site

    Gdansk, 80-803
    Poland

    Site Not Available

  • Novartis Investigative Site

    Krakow, 31-070
    Poland

    Site Not Available

  • Novartis Investigative Site

    Lodz, 90-436
    Poland

    Site Not Available

  • Novartis Investigative Site

    Lublin, 20-079
    Poland

    Site Not Available

  • Novartis Investigative Site

    Iasi, 700401
    Romania

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  • Novartis Investigative Site

    Badalona, Catalunya 08916
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08036
    Spain

    Site Not Available

  • Novartis Investigative Site

    Alicante, Comunidad Valenciana 03010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46014
    Spain

    Site Not Available

  • Novartis Investigative Site

    Alcorcon, Madrid 28922
    Spain

    Site Not Available

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madird, 28041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Goethenburg, 413 45
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Goteborg, 413 46
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Gothenburg,
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Malmo, 214 28
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Stockholm, 17176
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Geneve, 1205
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Lausanne, CH-1011
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Zuerich, 8091
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Bradford, West Yorkshire BD5 0NA
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Leeds, West Yorkshire LS7 4SA
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Salford, M6 8HD
    United Kingdom

    Site Not Available

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