Status:
WITHDRAWN
Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.
Lead Sponsor:
Rockefeller University
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
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 TH...
Detailed Description
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 TH...
Eligibility Criteria
Inclusion
- Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of medical history
- Have HS lesions present in at least 2 distinct anatomical areas
- Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had contraindications to oral antibiotic treatment of their HS
- Have a total abscess and inflammatory nodule (AN) count greater than or equal to 3 at the screening and baseline visit
- Must agree with daily use (throughout the study of one of the following over the counter treatments to body areas affected with HS lesions: either soap and water, a topical antiseptic was containing chlorhexidine gluconate, triclosan or benzoyl peroxide, or a dilute bleach bath.
Exclusion
- HIV Positive
- Active Hepatitis B or C Infection
- Pregnant or Breastfeeding
- No concurrent use of any systemic antibiotics/retinoids/immunosuppressants (require washout period of 5 half lives)
- Any medical, psychological or social condition that, in the opinion of the investigator would jeopardize the health or well being of the participant during any study procedures or integrity of the data
- Has a draining fistula count greater than 20 at baseline visit Any other active skin disease (bacterial fungal or viral infection) that could have interfered with the assessment of HS
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04084665
Start Date
June 1 2020
End Date
July 30 2020
Last Update
June 5 2020
Active Locations (1)
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1
Rockefeller Unviersity
New York, New York, United States, 10065