- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02592018
Immunologic Response to Secukinumab in Plaque Psoriasis
31. august 2020 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Francisco, California, Forente stater, 94118
- UCSF Psoriasis and Skin Treatment Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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Hva måler studien?
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2016
Primær fullføring (Faktiske)
1. desember 2018
Studiet fullført (Faktiske)
1. desember 2018
Datoer for studieregistrering
Først innsendt
16. oktober 2015
Først innsendt som oppfylte QC-kriteriene
28. oktober 2015
Først lagt ut (Anslag)
30. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAIN457AUS04T
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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