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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

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:

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.

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

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

NCT ID

NCT02592018

First Posted

October 16, 2015

Last Updated

August 31, 2020

Sponsor

University of California, San Francisco

Collaborators

Novartis Pharmaceuticals

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

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

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

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Immunologic Response to Secukinumab in Plaque Psoriasis

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