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Immunologic Response to Secukinumab in Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02592018
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Wilson Liao, MD, University of California, San Francisco

Brief Summary:
This is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Secukinumab Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab
All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
Drug: Secukinumab
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.
Other Name: Cosentyx




Primary Outcome Measures :
  1. Change in percentage of CD4+ T effector cells expressing IL17 compared to baseline [ Time Frame: week 2 ]
  2. Change in percentage of CD4+ T effector cells expressing IL17 compared to baseline [ Time Frame: week 4 ]
  3. Change in percentage of CD4+ T effector cells expressing IL17 compared to baseline [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Change in number of differentially expressed genes in CD4+ effectors compared to baseline [ Time Frame: week 2 ]
    by RNA-seq

  2. Change in number of differentially expressed genes in CD4+ effectors compared to baseline [ Time Frame: week 4 ]
    by RNA-seq

  3. Change in number of differentially expressed genes in CD4+ effectors compared to baseline [ Time Frame: week 12 ]
    by RNA-seq

  4. Change in number of differentially expressed genes in CD4+ T Regs compared to baseline [ Time Frame: week 2 ]
    by RNA-seq

  5. Change in number of differentially expressed genes in CD4+ T Regs compared to baseline [ Time Frame: week 4 ]
    by RNA-seq

  6. Change in number of differentially expressed genes in CD4+ T Regs compared to baseline [ Time Frame: week 12 ]
    by RNA-seq

  7. Change in number of differentially expressed genes in CD8+ T effectors compared to baseline [ Time Frame: week 2 ]
    by RNA-seq

  8. Change in number of differentially expressed genes in CD8+ T effectors compared to baseline [ Time Frame: week 4 ]
    by RNA-seq

  9. Change in number of differentially expressed genes in CD8+ T effectors compared to baseline [ Time Frame: week 12 ]
    by RNA-seq



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592018


Locations
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United States, California
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Novartis Pharmaceuticals

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Responsible Party: Wilson Liao, MD, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02592018     History of Changes
Other Study ID Numbers: CAIN457AUS04T
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs