Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.

Part of paid clinical trials in New York, New York.

Sponsor
Rockefeller University
Study ID
NCT04084665
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Hidradenitis Suppurativa (HS) is a severe, chronic debilitating disease with a variable and incomplete response to current treatments. Existing immunological studies have found dysregulation in the TH17:Treg axis with an increase in inflammatory mediators including TNFalpha, IL-17 IL-23 (amongst others) in lesional skin. Multiple cell typesincluding CD4+ cells, dendritic cells and macrophages infiltrate active lesions of HS and produce this major contribution from the Th17 axis. One of the main barriers to the development of novel and effective treatments for HS is the lack of biomarker(s) of disease activity, as well as our incomplete understanding of the pathogenesis of this disease. Given the pronounced contribution of Th17 pathway (including interleukin-23) in the inflammation in HS, further investigation into the role of this axis in the pathogenicity of HS is essential. Guselkumab is a fully human interluekin-23 antagonist, FDA approved for the treatment of moderate to severe psoriasis in participants 18 years and over. Guselkumab is a novel potential therapy.

Key Dates

Start date
Jun 1, 2020
Status verified
Jun 2020
Primary completion
Jul 30, 2020
Completion
Jul 30, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Intervention
    Guselkumab 200mg q4 weekly

Primary Outcome Measure

Biomarkers at Week 12 [ Time Frame: Week 12 compared with baseline (Week 0). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rockefeller UnviersityNew YorkNew York10065-

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