Immunologic Response to Secukinumab in Plaque Psoriasis

Completed · Phase 4

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT02592018

Run by

University of California, San Francisco

People needed

15

Starts

2016-10-01

Expected to finish

2018-12-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSF Psoriasis and Skin Treatment Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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