- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02547714
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
A Multi-center, Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety for 16 Weeks in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Aichi
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Nagoya city, Aichi, Japan, 467-8602
- Novartis Investigative Site
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Fukuoka
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Fukuoka-city, Fukuoka, Japan, 814-0180
- Novartis Investigative Site
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Kanagawa
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Isehara-city, Kanagawa, Japan, 259-1193
- Novartis Investigative Site
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Osaka
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Osaka-city, Osaka, Japan, 550-0012
- Novartis Investigative Site
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Tochigi
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Shimotsuke-city, Tochigi, Japan, 329-0498
- Novartis Investigative Site
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Tokyo
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Chiyoda-ku, Tokyo, Japan, 102-8798
- Novartis Investigative Site
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Itabashi-ku, Tokyo, Japan, 173-8610
- Novartis Investigative Site
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Itabashi-ku, Tokyo, Japan, 173-8606
- Novartis Investigative Site
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Minato-ku, Tokyo, Japan, 105-8471
- Novartis Investigative Site
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Shinagawa-ku, Tokyo, Japan, 141 8625
- Novartis Investigative Site
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Shinjuku-Ku, Tokyo, Japan, 169-0073
- Novartis Investigative Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion criteria:
- Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
- PASI score of 10 or greater and
- IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)
Exclusion Criteria:
- Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
- Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L [2.0 mg/dL]) and hypertension at screening.
Other protocol-defined inclusion/exclusion criteria may apply
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Secukinumab (AIN457) 300 mg
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
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Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
Tidsramme: Week 16
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 75 was defined as participants achieving >= 75% improvement from baseline.
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Week 16
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean Percent Change From Baseline in PASI Score
Tidsramme: Week 4
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 change from baseline indicates improvement.
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Week 4
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Percentage of Participants Achieving PASI 50 or PASI 75
Tidsramme: Week 4
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively. |
Week 4
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Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response
Tidsramme: Week 16
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PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of 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. |
Week 16
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Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Tidsramme: Week 16
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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 negative mean percentage change from baseline indicates improvement.
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Week 16
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Percentage of Participants Achieving DLQI 0 or 1
Tidsramme: Week 16
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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.
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Week 16
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAIN457AJP01
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