- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02592018
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
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
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California
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San Francisco, California, Förenta staterna, 94118
- UCSF Psoriasis and Skin Treatment Center
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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:
- 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
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 |
|---|---|
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to Week 12
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Baseline to Week 12
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to Week 12
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by RNA-seq
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Baseline to Week 12
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
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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