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

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ClinicalTrials.gov Identifier: NCT03307447
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Narrows Institute for Biomedical Research

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Secukinumab Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Treatment arm
Cosentyx (Secukinumab) 300 mg subcutaneous injection at weeks 0, 1, 2, 3 and 4 followed by every 4 weeks until 16 weeks
Drug: Secukinumab
Secukinumab 300 mg subcutaneous injection
Other Name: cosentyx




Primary Outcome Measures :
  1. Elucidate drug mechanism of action by monitoring morphologic changes in lesional vs. perilesional psoriatic plaques using optical coherence tomography (OCT). [ Time Frame: week 12 ]
    Lesional and peri-lesional skin will be monitored using OCT for improvement from baseline by measuring changes epidermal, dermal and DEJ, as well as changes in vasculature.


Secondary Outcome Measures :
  1. Compare timing of subclinical improvement on OCT to the proportion of patients who achieve a reduction in PASI score by at least 75% (PASI 75) and/or score of 0 or 2-point improvement on the IGA (mod 2011) by week 12. [ Time Frame: week 12 ]
    The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) or achieve a score of 0 on IGA, or at least a 2 point improvement, at week 12.

  2. Compare the onset/timing of subclinical improvement on OCT imaging to patients who achieve a 90% or 100% (PASI 90 and PASI 100) improvement from baseline in the PASI [ Time Frame: week 16 ]
    a. To compare the onset/timing of subclinical improvement on OCT imaging to patients who achieve a 90% or 100% (PASI 90 and PASI 100) improvement from baseline in the PASI by week 16



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subject at least 18 years of age with a diagnosis of moderate to severe chronic plaque psoriasis vulgaris for at least 6 months.
  2. Subjects must be candidates for systemic therapy and have at least moderate to severe psoriasis, as defined by the Psoriasis Area and Severity Index (PASI) score: body surface 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 requirements of this study protocol.
  5. Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a 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 or QuantiFERON, he/she has completed the appropriate prophylaxis.
  7. Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.

Exclusion Criteria:

  1. Patients with guttate, erythrodermic, exfoliative, or pustular psoriasis, other skin conditions affecting the treatment area, severe hepatic disorders or severe renal insufficiency
  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 had topical 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 the trial.
  5. Any subject who is pregnant or refuses to practice an acceptable method of birth control (as stated in inclusion criterion # 4)
  6. History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive or indeterminate PPD or QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) is completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to randomization and the course of prophylaxis 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 B or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307447


Contacts
Contact: Bethanne Wenzel (718) 836-6600 ext 8924 bethanne.wenzel@va.gov

Locations
United States, New York
VA NY Harbor Healthcare System Recruiting
Brooklyn, New York, United States, 11209
Contact: Bethanne Wenzel    718-836-6600    Bethanne.wenzel@va.gov   
Principal Investigator: Orit Markowitz, MD         
Sub-Investigator: Daniel Siegel, MD         
Sponsors and Collaborators
Narrows Institute for Biomedical Research
Novartis

Responsible Party: Narrows Institute for Biomedical Research
ClinicalTrials.gov Identifier: NCT03307447     History of Changes
Other Study ID Numbers: #1617
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Narrows Institute for Biomedical Research:
optical coherence tomography

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs