- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02592018
Immunologic Response to Secukinumab in Plaque Psoriasis
31. august 2020 opdateret af: University of California, San Francisco
Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling
This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.
Studieoversigt
Detaljeret beskrivelse
Quantitative analysis of the immunologic changes in immune cell populations will be performed after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles in psoriasis patients will also be compared to healthy control skin surgical discard specimens (n=10).
The number of differentially expressed genes in each cell population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to baseline.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94118
- UCSF Psoriasis and Skin Treatment Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
- Subject is considered a candidate for phototherapy or systemic therapy
- PASI ≥ 12
- PGA ≥ 3
- Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR negative, subject initiated prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
- Physical exam within clinically acceptable limits.
Exclusion Criteria:
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age.
- Subject has predominately non-plaque form of psoriasis.
- Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
- Subject has drug-induced psoriasis.
- Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
- Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
- Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
- Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis defined by positive QFT with a negative chest X-ray without prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
- Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Secukinumab
All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
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Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsramme: Baseline to Week 2
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Baseline to Week 2
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Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsramme: Baseline to Week 4
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Baseline to Week 4
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Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsramme: Baseline to Week 12
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Baseline to Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
Tidsramme: Baseline to Week 2
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by RNA-seq
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Baseline to Week 2
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Tidsramme: Baseline to Week 4
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by RNA-seq
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Baseline to Week 4
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Tidsramme: Baseline to Week 12
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by RNA-seq
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Baseline to Week 12
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Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Tidsramme: Baseline to Week 2
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by RNA-seq
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Baseline to Week 2
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Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Tidsramme: Baseline to Week 4
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by RNA-seq
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Baseline to Week 4
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Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Tidsramme: Baseline to Week 12
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by RNA-seq
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Baseline to Week 12
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Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Tidsramme: Baseline to Week 2
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by RNA-seq
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Baseline to Week 2
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Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Tidsramme: Baseline to Week 4
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by RNA-seq
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Baseline to Week 4
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Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Tidsramme: Baseline to Week 12
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by RNA-seq
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Baseline to Week 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2016
Primær færdiggørelse (Faktiske)
1. december 2018
Studieafslutning (Faktiske)
1. december 2018
Datoer for studieregistrering
Først indsendt
16. oktober 2015
Først indsendt, der opfyldte QC-kriterier
28. oktober 2015
Først opslået (Skøn)
30. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2020
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAIN457AUS04T
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Kliniske forsøg med Psoriasis
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ProgenaBiomeTrukket tilbagePsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis ansigt | Psoriasis negl | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaForenede Stater
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Clin4allAktiv, ikke rekrutterendePsoriasis i hovedbunden | Psoriasis negl | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrankrig
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Alumis IncAktiv, ikke rekrutterendePsoriasis | Plaque Psoriasis | Psoriasis (PsO) | Moderat psoriasis | Alvorlig psoriasisForenede Stater, Canada, Australien, Tyskland, Spanien, Ungarn, Japan, Bulgarien, Polen, Tjekkiet, Estland, Letland, Puerto Rico, Portugal, Sydkorea, Frankrig
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AmgenAfsluttetPsoriasis-Psoriasis | Plaque-type psoriasisForenede Stater
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Centre of Evidence of the French Society of DermatologyRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis Palmaris | Psoriatisk erytrodermi | Psoriasis negl | Psoriasis Guttate | Psoriasis omvendt | Psoriasis pustulærFrankrig
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Innovaderm Research Inc.AfsluttetPsoriasis i hovedbunden | Pustulær Palmo-plantar Psoriasis | Ikke-pustulær Palmo-plantar Psoriasis | Albue Psoriasis | Psoriasis i underbenetCanada
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Chongqing Genrix Biopharmaceutical Co., LtdXiangya Hospital of Central South UniversityIkke rekrutterer endnuPlaque Psoriasis | Psoriasisgigt | Psoriasis i hovedbunden | Negle Psoriasis | Palmoplantar Psoriasis | Genital PsoriasisKina
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UCB Biopharma S.P.R.L.AfsluttetModerat til svær psoriasis | Generaliseret pustulær psoriasis og erytrodermisk psoriasisJapan
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Caja Costarricense de Seguro SocialIkke rekrutterer endnuPsoriasis | Psoriasis (PsO) | Psoriasis arthritisCosta Rica
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PfizerAfsluttetPsoriasis Vulgaris | Pustuløs psoriasis | Psoriasis Arthropathica | Erytrodermisk psoriasisJapan
Kliniske forsøg med Secukinumab
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Novartis PharmaceuticalsAktiv, ikke rekrutterende
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Novartis PharmaceuticalsIkke rekrutterer endnuEnthesitis-relateret arthritis (ERA) | Juvenil psoriasis arthritis (JPSA)
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Novartis PharmaceuticalsRekrutteringHidradenitis Suppurativa (HS)Kina
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Novartis PharmaceuticalsAktiv, ikke rekrutterendeHidradenitis SuppurativaForenede Arabiske Emirater
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Novartis PharmaceuticalsRekrutteringHidradenitis Suppurativa | Juvenil idiopatisk arthritis | Pædiatrisk Plaque PsoriasisSydkorea
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Duke UniversityRekruttering
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Novartis PharmaceuticalsAfsluttetKæmpecelle arteritis | Polymyalgi RheumaticaSpanien, Schweiz, Forenede Stater, Italien, Portugal, Tjekkiet
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Novartis PharmaceuticalsAktiv, ikke rekrutterendeModerat til svær Plaque PsoriasisRusland
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Taizhou Mabtech Pharmaceutical Co.,LtdAktiv, ikke rekrutterende
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Novartis PharmaceuticalsAfsluttetSkjoldbruskkirtlen øjensygdom | Graves orbitopatiTyskland