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Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

17 marca 2015 zaktualizowane przez: Novartis Pharmaceuticals

A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

43

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Austria
      • Graz, Austria, A-8036
        • Novartis Investigative Site
      • Vienna, Austria, A-1220
        • Novartis Investigative Site
      • Wels, Austria, 4600
        • Novartis Investigative Site
  • Francja
      • Rouen, Francja, 76031
        • Novartis Investigative Site
      • Toulouse Cedex, Francja, 31059
        • Novartis Investigative Site
  • Indie
    • Karnataka
      • Mangalore, Karnataka, Indie, 575 004
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, Indie, 440 010
        • Novartis Investigative Site
      • Nashik, Maharashtra, Indie, 422 001
        • Novartis Investigative Site
  • Japonia
    • Chiba
      • Kisarazu, Chiba, Japonia, 292-8535
        • Novartis Investigative Site
    • Tokyo
      • Hachioji-city, Tokyo, Japonia, 193-0998
        • Novartis Investigative Site
      • Minato-ku, Tokyo, Japonia, 105-8471
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japonia, 160-0023
        • Novartis Investigative Site
  • Kanada
    • Ontario
      • Barrie, Ontario, Kanada, L4M 6L2
        • Novartis Investigative Site
      • Waterloo, Ontario, Kanada, N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Kanada, H2K 4L5
        • Novartis Investigative Site
  • Niemcy
      • Essen, Niemcy, 45147
        • Novartis Investigative Site
      • Frankfurt, Niemcy, 60590
        • Novartis Investigative Site
      • Hamburg, Niemcy, 22143
        • Novartis Investigative Site
      • Luebeck, Niemcy, 23538
        • Novartis Investigative Site
      • Mainz, Niemcy, 55131
        • Novartis Investigative Site
  • Stany Zjednoczone
    • Florida
      • Jacksonville, Florida, Stany Zjednoczone, 32216
        • Novartis Investigative Site
      • West Palm Beach, Florida, Stany Zjednoczone, 33409
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02111
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Stany Zjednoczone, 63117
        • Novartis Investigative Site
    • North Carolina
      • Greensboro, North Carolina, Stany Zjednoczone, 27401
        • Novartis Investigative Site
    • South Carolina
      • Greer, South Carolina, Stany Zjednoczone, 29651
        • Novartis Investigative Site
  • Słowacja
    • Slovak Republic
      • Kosice, Slovak Republic, Słowacja, 040 15
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

  • Written Informed Consent must be obtained before any assessment is performed,
  • Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

  • Pregnant women or lactating women
  • Forms of psoriasis other than chronic plaque -type
  • Ongoing use of prohibited psoriasis treatments
  • Ongoing use of other non-psoriasis prohibited treatments
  • Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
  • Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
  • UV therapy or excessive exposure to sunlight

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: AIN457 subcutaneous (s.c.)
During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Lek: secukinumab 150mg
secukinumab 150mg (2 injections per dose)
Eksperymentalny: AIN457 I.V.
During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Lek: secukinumab 10mg/kg i.v. regimen
secukinumab 10mg/kg i.v. regimen

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI
Ramy czasowe: Week 8
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Week 8
Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response
Ramy czasowe: Week 8
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Week 8

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Ramy czasowe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Mean Percent Change From Baseline in PASI Scores
Ramy czasowe: Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.
Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants in Each IGA Mod 2011 Score Category
Ramy czasowe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1
Ramy czasowe: Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement.
Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores
Ramy czasowe: Baseline, weeks 8, 16, 24, 32 and 40
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Baseline, weeks 8, 16, 24, 32 and 40
Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)
Ramy czasowe: Baseline, weeks 8, 16, 24, 32 and 40
The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.
Baseline, weeks 8, 16, 24, 32 and 40
Number of Participants Who Developed Anti-secukinumab Antibodies
Ramy czasowe: Baseline, weeks 12, 24 and 40
The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.
Baseline, weeks 12, 24 and 40
Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy
Ramy czasowe: End of study
This outcome measure was not analyzed due to the small sample size of the study (43 participants).
End of study

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2011

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2013

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2013

Daty rejestracji na studia

Pierwszy przesłany

5 sierpnia 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 sierpnia 2011

Pierwszy wysłany (Oszacować)

9 sierpnia 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

18 marca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 marca 2015

Ostatnia weryfikacja

1 marca 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CAIN457A2307
  • 2011-002510-36 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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