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Immunologic Response to Secukinumab in Plaque Psoriasis

31 augusti 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

15

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • San Francisco, California, Förenta staterna, 94118
        • UCSF Psoriasis and Skin Treatment Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Ability to provide written informed consent and comply with the protocol.
  2. At least 18 years of age.
  3. Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
  4. Subject is considered a candidate for phototherapy or systemic therapy
  5. PASI ≥ 12
  6. PGA ≥ 3
  7. 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.
  8. Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
  9. Physical exam within clinically acceptable limits.

Exclusion Criteria:

  1. Subject is unable to provide written informed consent or comply with the protocol.
  2. Subject is younger than 18 years of age.
  3. Subject has predominately non-plaque form of psoriasis.
  4. Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
  5. Subject has drug-induced psoriasis.
  6. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
  7. Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
  8. Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
  9. 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.
  10. History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
  11. 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.
  12. History of known or suspected intolerance to any of the ingredients of the investigational study product.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Secukinumab
All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
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.
Andra namn:
  • Cosentyx

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsram: Baseline to Week 2
Baseline to Week 2
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsram: Baseline to Week 4
Baseline to Week 4
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsram: Baseline to Week 12
Baseline to Week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
Tidsram: Baseline to Week 2
by RNA-seq
Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Tidsram: Baseline to Week 4
by RNA-seq
Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Tidsram: Baseline to Week 12
by RNA-seq
Baseline to Week 12
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Tidsram: Baseline to Week 2
by RNA-seq
Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Tidsram: Baseline to Week 4
by RNA-seq
Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Tidsram: Baseline to Week 12
by RNA-seq
Baseline to Week 12
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Tidsram: Baseline to Week 2
by RNA-seq
Baseline to Week 2
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Tidsram: Baseline to Week 4
by RNA-seq
Baseline to Week 4
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Tidsram: Baseline to Week 12
by RNA-seq
Baseline to Week 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2016

Primärt slutförande (Faktisk)

1 december 2018

Avslutad studie (Faktisk)

1 december 2018

Studieregistreringsdatum

Först inskickad

16 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

28 oktober 2015

Första postat (Uppskatta)

30 oktober 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 september 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2020

Senast verifierad

1 augusti 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CAIN457AUS04T

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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