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- Withdrawn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
- Guselkumab — DRUGGuselkumab
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: InterventionGuselkumab 200mg q4 weekly
Primary Outcome Measure
Biomarkers at Week 12 [ Time Frame: Week 12 compared with baseline (Week 0). ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rockefeller Unviersity | New York | New York | 10065 | - |
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