Brief description of trial (Data source: BASEC)
Wir führen diese Studie durch, um die kurz- und langfristige Wirksamkeit, Sicherheit und Verträglichkeit von subkutan injiziertem Secukinumab nach 12 Wochen im Vergleich zu Placebo und Etanercept und nach 40 Wochen im Vergleich zu Etanercept allein bei Patienten zwischen 6 und 18 Jahren mit schwerer chronischer Plaque-Psoriasis zu untersuchen.
Dies ist eine klinische Studie. Das Design dieser Studie wurde von der Pädiatrischen Abteilung der Europäischen Arzneimittelagentur (EMA) genehmigt. Ungefähr 160 Patienten werden an dieser Studie in etwa 70 Zentren weltweit teilnehmen. In der Schweiz werden es ca. 2-3 Patienten sein.
Secukinumab ist ein Medikament, das von manchen Gesundheits-behörden, darunter die Europäische Arzneimittelagentur (EMA) sowie US Food and Drug Administration (FDA), zur Behandlung von erwachsenen Personen mit Psoriasis zugelassen wurde.
Health conditions investigated(Data source: BASEC)
Schwere Form der Schuppenflechte (Plaque Psoriasis)
Health conditions
(Data source: WHO)
Chronic Severe Plaque-type Psoriasis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Es gibt vier möglichen Behandlungsgruppen :
niedrige Dosis von Secukinumab (75 bis 150 mg je nach Gewicht),
hohe Dosis von Secukinumab (150 bis 300 mg je nach Gewicht),
Etanercept (0.8 mg/kg bis max. 50 mg) oder
Placebo (das ist ein Scheinmedikament, enthält keinen Wirkstoff).
Die Secukinumab-Lösung wird mittels Spritzen für die Injektion unter die Haut (subkutane Injektion) angewendet. Die in dieser Studie verwendete Dosis ist gewichtsabhängig; die erforderliche Dosis wird durch die Anwendung von ein bis zwei Fertigspritzen erreicht. Die Anwendung von Secukinumab in Abhängigkeit des Gewichtes ist keine von Swissmedic zugelassene Anwendungsform, da bei erwachsenen Patienten mit Schuppenflechte jeweils 300mg Secukinumab vorgesehen sind. Hingegen stellt die gewichtsangepasste Anwendung des zweiten Medikamentes Etanercept bei Kindern eine gebräuchliche Verabreichungsform dar.
Interventions
(Data source: WHO)
Biological: Experimental : Secukinumab low dose;Biological: Experimental: Secukinumab high dose;Biological: Placebo Comparator: Secukinumab Placebo;Biological: Active Comparator: Etanercept
Criteria for participation in trial
(Data source: BASEC)
- Alter zwischen 6-17 Jahre
- mittelschwer-schwere Form der Schuppenflechte seit mindestens 3 Monaten bestehend
Exclusion criteria
(Data source: BASEC)
- Andere Form der Psoriasis
- Frauen in gebärfähigem Alter, die nicht geeignete Verhütungsmethoden anwenden möchten
- Andere Erkrankungen mit Einfluss auf die Einschliessbarkeit
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: 17 Years
Minimum age: 6 Years
Inclusion criteria:
- Must be 6 to less than 18 years of age at the time of randomization
- Plaque-type psoriasis history for at least 3 months.
Severe plaque-type psoriasis meeting all of the following three criteria:
- PASI score of 20 or greater,
- Investigator's Global Assessment (IGA) score of 4
- Total body surface area (BSA) affected of 10% or greater.
- Patient being regarded by the investigator to be a candidate for systemic therapy
because of:
1. inadequate control of symptoms with topical treatment, or
2. failure to respond to or tolerate previous systemic treatment and/or UV therapy
Exclusion criteria
- Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
pustular, erythrodermic, guttate) at randomization.
- Current drug-induced psoriasis.
- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- Underlying condition (including, but not limited to metabolic, hematologic, renal,
hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal)
which in the opinion of the investigator significantly immunocompromises the subject
and/or places the subject at unacceptable risk for receiving an immunomodulatory
therapy
- History of an ongoing, chronic or recurrent infectious disease, or evidence of
untreated tuberculosis.
- History of lymphoproliferative disease or history of malignancy of any organ system
within the past 5 years.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply.
-
Further information on trial
Recruitment status
Completed
Academic title
(Data source: WHO)
A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Number and Percentage of Participants Achieving a 75% Improvement From Baseline in PASI Score at Week 12;Number and Percentage of Participants Who Showed Investigator's Global Assessment (IGA) Mod 2011 Response of 0 or 1 at Week 12
Secundary end point
(Data source: WHO)
Number and Percentage of Participants Achieving a 90% Improvement From Baseline in PASI Score at Week 12;Number and Percentage of Participants Achieving a 50%, 100% Improvement From Baseline in PASI Score at Week 12;Number and Percentage of Participants Achieving a 50%, 75%, 90% or 100% Improvement From Baseline in PASI Score and IGA Mod 2011 Score of 0 or 1 up to Week 12 (Induction);Number and Percentage of Participants Achieving a 50%, 75%, 90% or 100% Improvement From Baseline in PASI Score and IGA Mod 2011 Score of 0 or 1 Up to Week 52 (Maintenance);Change From Baseline in Psoriasis Area & Severity Index (PASI) Score at Week 12;Change From Baseline in Psoriasis Area & Severity Index (PASI) Scores at Week 52;Percentage of Participants in IGA Mod 2011 Score Categories at Week 12;Percentage of Participants in IGA Mod 2011 Score Categories at Week 52;Percentage Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Score Up to Week 12 (Induction);Percentage Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Score Up to Week 52 (Maintenance);Number and Percentage of Participants Achieving a Children's DLQI Score of 0 or 1 Over Time up to Week 12 (Induction);Number and Percentage of Participants Achieving a Children's DLQI Score of 0 or 1 Over Time up to Week 52 (Maintenance);Number and Percentage of Participants With Clinically Important Reduction in Disability as Evaluated by CHAQ Questionnaire Over Time at Week 12;Number and Percentage of Participants With Clinically Important Reduction in Disability as Evaluated by CHAQ Questionnaire Over Time at Week 52
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
St. Gallen, Zurich
Countries
(Data source: WHO)
Belgium, Brazil, Canada, Colombia, Egypt, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Japan, Latvia, Poland, Romania, Russian Federation, Spain, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Irene Beck
+41 79 586 95 83
irene.beck@novartis.com
Contact for general information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact for scientific information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
09.05.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00135
Secondary ID (Data source: WHO)
2014-005663-32
CAIN457A2310
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