Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03055494
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — BIOLOGICAL
    Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48
  • Placebo — BIOLOGICAL
    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

Study Details

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.

Key Dates

Start date
Apr 18, 2017
Status verified
Mar 2023
Primary completion
Apr 25, 2018
Completion
Feb 26, 2019

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12 [ Time Frame: 12 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteHot SpringsArkansas71913-
Novartis Investigative SiteLos AngelesCalifornia90033-
Novartis Investigative SiteSanta AnaCalifornia92701-
Novartis Investigative SiteAtlantaGeorgia30342-
Novartis Investigative SiteIndianapolisIndiana46256-
Novartis Investigative SiteEast WindsorNew Jersey08520-
Novartis Investigative SiteWest OrangeNew Jersey07052-
Novartis Investigative SiteBuffaloNew York14203-
Novartis Investigative SiteNew YorkNew York10025 1737-
Novartis Investigative SiteNew YorkNew York10065-
Novartis Investigative SitePortlandOregon97223-
Novartis Investigative SitePittsburghPennsylvania15213-3403-
Novartis Investigative SiteWebsterTexas77004-
Novartis Investigative SiteMurrayUtah84107-
Novartis Investigative SiteNorfolkVirginia23507-

Find similar trials in Hot Springs, AR

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Novartis Investigative Site· Hot Springs, ARNovartis Investigative Site· Los Angeles, CANovartis Investigative Site· Santa Ana, CANovartis Investigative Site· Atlanta, GANovartis Investigative Site· Indianapolis, INNovartis Investigative Site· East Windsor, NJ

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