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Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients (ObePso-S)

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ClinicalTrials.gov Identifier: NCT03055494
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will provide a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Biological: Secukinumab Biological: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore Changes in Subcutaneous Adipose Tissue and Modulation of Skin Inflammation After 12 Weeks of Treatment With Secukinumab, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : April 26, 2018
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab
Eligible patients will receive secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3 and 4 followed by monthly dosing up to Week 48
Biological: Secukinumab
Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 followed by monthly dosing up to Week 48

Placebo Comparator: Placebo
Eligible patients will receive placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients will be switched to treatment with secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48
Biological: Placebo
Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48




Primary Outcome Measures :
  1. Response of psoriasis skin lesions to treatment [ Time Frame: 12 weeks ]
    Response in skin histology/K16 expression to treatment (yes, no)

  2. Response of psoriasis skin lesions to treatment [ Time Frame: 12 weeks ]
    Psoriasis Area and Severity Index 90 (yes, no)


Secondary Outcome Measures :
  1. Vital signs, Clinical laboratory variables [ Time Frame: 12 weeks ]
    Vital signs (blood pressure, weight, waist circumference, body mass index), clinical laboratory variables (glucose, insulin, hs-CRP, HOMA-IR, HbA1c)

  2. Response of psoriasis skin lesions to treatment [ Time Frame: 52 weeks ]
    Response in skin histology/K16 expression to treatment (yes, no)

  3. Response of psoriasis skin lesions to treatment [ Time Frame: 52 weeks ]
    Psoriasis Area and Severity Index 90 (yes, no)



Information from the National Library of Medicine

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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:

  • Written informed consent must be obtained before any assessment is performed
  • Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
  • Moderate to severe plaque psoriasis as defined at baseline by:

    • ≥10% Body Surface Area (BSA) involvement and
    • PASI total score of ≥12 and
    • IGA mod 2011 score of ≥3 (based on a scale of 0-4)

Exclusion Criteria:

  • Forms of diagnosed psoriasis other than chronic plaque psoriasis
  • Medication-induced or medication exacerbated psoriasis
  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
  • Ongoing use of prohibited treatments
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT03055494


Locations
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United States, Arkansas
Novartis Investigative Site
Hot Springs, Arkansas, United States, 71913
United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90033
Novartis Investigative Site
Santa Ana, California, United States, 92701
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30342
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46256
United States, New Jersey
Novartis Investigative Site
East Windsor, New Jersey, United States, 08520
Novartis Investigative Site
West Orange, New Jersey, United States, 07052
United States, New York
Novartis Investigative Site
Buffalo, New York, United States, 14203
Novartis Investigative Site
New York, New York, United States, 10025 1737
Novartis Investigative Site
New York, New York, United States, 10065
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97223
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213-3403
United States, Texas
Novartis Investigative Site
Webster, Texas, United States, 77004
United States, Utah
Novartis Investigative Site
Murray, Utah, United States, 84107
United States, Virginia
Novartis Investigative Site
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Novartis Investigative Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03055494     History of Changes
Other Study ID Numbers: CAIN457AUS07
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs