Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).

Last updated: August 31, 2021
Sponsor: Narrows Institute for Biomedical Research
Overall Status: Active - Recruiting

Phase

4

Condition

Warts

Rash

Psoriasis And Psoriatic Disorders

Treatment

N/A

Clinical Study ID

NCT03307447
#1617
  • Ages > 18
  • All Genders

Study Summary

This is a phase IV, single-center, open label, single arm study in which a group of 30 subjects with moderate to severe plaque psoriasis will receive secukinumab therapy. Non-invasive imaging with optical coherence tomography (OCT) will be used to monitor the resolution of psoriatic plaques with treatment in comparison to observed clinical improvements. Early subclinical finding will be used to elucidate drug mechanism of action. Assessment will be based on intrasubject comparisons, and all findings will be compared to patients baseline imaging.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subject at least 18 years of age with a diagnosis of moderate to severechronic plaque psoriasis vulgaris for at least 6 months.
  2. Subjects must be candidates for systemic therapy and have at least moderate to severepsoriasis, as defined by the Psoriasis Area and Severity Index (PASI) score: bodysurface area (BSA) involvement >10% , PASI >12 and/or IGA modified (mod 2011) score of 3 ("moderate") or 4 ("severe"). [2-4]
  3. Patients must be naïve to prior biologic treatment
  4. Subject is able to provide written informed consent and comply with the requirementsof this study protocol.
  5. Subjects who are women of childbearing potential must have a negative urine pregnancytest at screening and must be practicing an adequate, medically acceptable method ofbirth control for at least 30 days before Day 0 and at least 6 months after the laststudy drug administration. Acceptable methods of birth control include intrauterinedevice (IUD); oral, transdermal, implanted or injected hormonal contraceptives (musthave been initiated at least 1 month before entering the study); tubal ligation;abstinence and barrier methods with spermicide. Otherwise, if not of childbearingpotential, subjects must: have a sterile or vasectomized partner; have had ahysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be ina menopausal state for at least a year.
  6. Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT)negative at the time of screening, or if patient has a history of positive PPD orQuantiFERON, he/she has completed the appropriate prophylaxis.
  7. Subject is judged to be in good general health as determined by the principalinvestigator based upon the results of medical history, laboratory profile, andphysical examination.

Exclusion

Exclusion Criteria:

  1. Patients with guttate, erythrodermic, exfoliative, or pustular psoriasis, other skinconditions affecting the treatment area, severe hepatic disorders or severe renalinsufficiency
  2. Have received systemic psoriasis treatments (such as psoralen and PUVA light therapy,cyclosporine, corticosteroids, methotrexate, retinoids, mycophenolate, hydroxyurea,azathioprine, sirolimus) or phototherapy within the previous 4 weeks; or have hadtopical therapy within the previous 2 weeks.
  3. Have received any biologic agent for the treatment of psoriasis, including etanercept,infliximab or adalimumab, alefacept, ustekinumab, or any other biologic agent
  4. Use of other drugs with potential effect on psoriasis, such as beta blockers,antimalarials, angiotensin-converting enzyme inhibitors, and lithium, are allowed,provided that treatment was not initiated and the dosage did not change during thetrial.
  5. Any subject who is pregnant or refuses to practice an acceptable method of birthcontrol (as stated in inclusion criterion # 4)
  6. History of an ongoing, chronic or recurrent infectious disease, or evidence oftuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive orindeterminate PPD or QFT test may participate in the study if a full tuberculosis workup (according to local practice/guidelines) is completed within 12 weeks prior torandomization and establishes conclusively that the subject has no evidence of activetuberculosis. If presence of latent tuberculosis is established, then treatment musthave been initiated at least for 4 weeks prior to randomization and the course ofprophylaxis is planned to be completed.
  7. Active Crohn's disease
  8. History of significant allergies or intolerances
  9. Imumunocompromised patients, including Subjects with a history of TB, HIV, Hepatitis Bor Hepatitis C infections
  10. Have had live vaccination within 12 weeks prior to study
  11. Have evidence of active infection, such as fever, within 5 days of dosing

Study Design

Total Participants: 30
Study Start date:
December 19, 2017
Estimated Completion Date:
December 31, 2021

Study Description

Secukinumab, an anti-IL-17A monoclonal antibody, is an effective treatment for moderate to severe plaque psoriasis.While there is an abundance of clinical data in the literature supporting the clinical efficacy of this therapy, there is limited data on early disease clearance and other histologic findings elucidating a drug mechanism of action. Hyper-proliferation of the epidermis and inflammation of dermis seen in psoriasis are thought to be due to persistent T-cell activation and production of several pro-inflammatory cytokines by dermal immune reaction. Therefore, with treatments with immunomodulatory effects, such as Secukinumab, monitoring markers of inflammation, angiogenesis, and collagen synthesis would be useful in establishing mechanism of action. While a skin biopsy can show these findings at one moment in time, it does not allow for repetitive monitoring overtime. The investigators propose the use of non-invasive imaging with Optical Coherence Tomography (OCT) to demonstrate histologic features of plaque psoriasis not clinically evident. Upon completion of the study, the investigators will assess when OCT improvements of psoriasis treatment are detectable and how these findings correlate to observed clinical improvements.

Connect with a study center

  • VA NY Harbor Healthcare System

    Brooklyn, New York 11209
    United States

    Active - Recruiting

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