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Immunologic Response to Secukinumab in Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF Psoriasis and Skin Treatment Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab

Arm Description

All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.

Outcomes

Primary Outcome Measures

Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline

Secondary Outcome Measures

Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
by RNA-seq
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
by RNA-seq
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
by RNA-seq

Full Information

First Posted
October 16, 2015
Last Updated
August 31, 2020
Sponsor
University of California, San Francisco
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02592018
Brief Title
Immunologic Response to Secukinumab in Plaque Psoriasis
Official Title
Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
All subjects will receive Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
Cosentyx
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Time Frame
Baseline to Week 2
Title
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Time Frame
Baseline to Week 4
Title
Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants
Description
by RNA-seq
Time Frame
Baseline to Week 2
Title
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 4
Title
Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 12
Title
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 2
Title
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 4
Title
Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 12
Title
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 2
Title
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 4
Title
Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline
Description
by RNA-seq
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson Liao, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Psoriasis and Skin Treatment Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Immunologic Response to Secukinumab in Plaque Psoriasis

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