Immunologic Response to Secukinumab in Plaque Psoriasis

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Drug: Secukinumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02592018

CAIN457AUS04T

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Secukinumab

Experimental group

Description:

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

Treatment:

Drug: Secukinumab