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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055494
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study provided 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

Detailed Description:

This was a randomized, double-blind, placebo-controlled, multicenter design. Patients with moderate to severe plaque psoriasis received secukinumab 300 mg or placebo, with randomization stratified by body weight (< 90 kg, ≥ 90 kg). There were 5 periods to the study: Screening (1 to 4 weeks), Double-blind Treatment Period (12 weeks), Double-blind Induction Period (4 weeks), Open-label Treatment Period (36 weeks), and Follow-up Period (1 week).

During the Double-blind Treatment Period, all patients attended study visits at Baseline, Weeks 1, 2, 3, 4, 8, and 12, and all doses of study treatment were self-administered at the study site. Patients underwent lesional (LS) and non-lesional (NL) skin biopsies at Baseline and Week 12. Assessments for the primary efficacy variable were performed at Week 12 before patients received their Week 12 dose. During the Double-blind Induction Period, patients randomized to placebo were switched to secukinumab 300 mg for the remainder of the study.

K16 and skin histology/biomarkers were assessed from skin biopsies. The Psoriasis Assessment and Severity Index (PASI) and the Investigator's Global Assessment modified 2011 scale (IGA mod 2011) were performed at specified study visits. Safety was monitored by vital signs, weight, waist circumference, body mass index (BMI), and clinical laboratory tests (serum chemistry, hematology, highsensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), homeostatic assessment of insulin resistance (HOMA-IR), viral serology, serum and urine pregnancy).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 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 25, 2018
Actual Study Completion Date : February 26, 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 received 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 was followed by monthly dosing up to Week 48
Other Name: AIN457

Placebo Comparator: Placebo
Eligible patients received placebo at randomization, Weeks 1, 2, 3, 4, and 8. At Week 12, patients were 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. Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 [ Time Frame: 12 weeks ]
    Response in skin histology/K16 expression to treatment (answered no)

  2. Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12 [ Time Frame: 12 weeks ]
    Psoriasis Area and Severity Index 90


Secondary Outcome Measures :
  1. Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52 [ Time Frame: 52 weeks ]
    Response in skin histology/K16 expression to treatment (answered no)

  2. Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52 [ Time Frame: 52 weeks ]
    Psoriasis Area and Severity Index 90

  3. Change in Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]
    Vital signs: summary statistics for change from baseline to Week 12

  4. Change in Diastolic Blood Pressure From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]
    Vital signs: summary statistics for change from baseline to Week 12

  5. Change in Body Weight From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]
    Vital signs: summary statistics for change from baseline to Week 12

  6. Change in Glucose Level From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]
    Vital signs: summary statistics for change from baseline to Week 12

  7. Change in Insulin Level From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]
    Vital signs: summary statistics for change from baseline to Week 12

  8. Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]
    Vital signs: summary statistics for change from baseline to Week 12

  9. Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12 [ Time Frame: baseline, Week 12 ]

    Vital signs: summary statistics for change from baseline to Week 12

    Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.


  10. Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12 [ Time Frame: baseline, week 12 ]

    Vital signs: summary statistics for change from baseline to week 12

    For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes.




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
Investigators
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Study Director: Study Lead Novartis Pharmaceuticals Novartis
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] February 23, 2018
Statistical Analysis Plan  [PDF] May 9, 2019

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03055494    
Other Study ID Numbers: CAIN457AUS07
First Posted: February 16, 2017    Key Record Dates
Results First Posted: March 10, 2020
Last Update Posted: March 10, 2020
Last Verified: February 2020
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
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
scalp psoriasis
plaque psoriasis
secukinumab
AIN457
biologic
monoclonal antibod
psoriasis
AIN457A
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases