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Immunologic Response to Secukinumab in Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Immunologic Response to Secukinumab in Plaque Psoriasis

Characterization of the Response to Secukinumab in Plaque Psoriasis Using Novel Immunologic and Genetic Profiling

NCT02592018•University of California, San Francisco

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+2 more criteria

Locations (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, United States

Key Dates

Start Date

October 1, 2016

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2018

Last Updated

September 16, 2020

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Secukinumab

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunologic Response to Secukinumab in Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments