Psoriasis Clinical Trial
Immunologic Response to Secukinumab in Plaque Psoriasis
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.
Full 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 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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
San Francisco California, 94118, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.