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CompletedNCT00795574HS2006Updated Nov 24, 2008

Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa

A Phase 2 interventional study of infliximab and Placebo Comparator in Hidradenitis Suppurativa, sponsored by Florida Academic Dermatology Centers. Completed at 1 site in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-11-24.

Sponsored by Florida Academic Dermatology Centers · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

A study to assess the safety and efficacy of the IV drug infliximab for the treatment of hidradenitis suppurativa

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • Hidradenitis Suppurativa
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 38 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Florida Academic Dermatology Centers is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Person must have moderate to severe Hidradenitis suppurativa
  • Multiple ER or doctors visits related to HS
  • Intralesional kenalog injection >5/year, but none within 3 months of entry
  • HS >1 year duration
  • Failed systemic retinoids, but not within 3 months of entry
  • Failed at least one prior course of antibiotic therapy, which must not have been administered within 3 months of entry to the study (excluding the recommended antibiotic regimen given immediately before randomization for evidence of active infection
  • History of surgery (reconstructive), but not within 3 months of entry

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion
  • Known allergy against infliximab
  • Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
  • Have had any previous treatment with monoclonal antibodies or antibody fragments.
  • Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
  • Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  • Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 26 on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules.
  • Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
  • Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
  • Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    infliximab

    Double blind placebo cross-over

    Drug: infliximab · Drug: Placebo Comparator

  • Placebo comparator
    Placebo

    Double blind placebo controlled cross-over

    Drug: Placebo Comparator

Interventions

  • Druginfliximab

    Dosing is 5mgs/kg at weeks 0,2 and 6 to complete loading dose of drug and then every 8 weeks thereafter until end of treatment phase.

  • DrugPlacebo Comparator

    5mgs /kg given IV over a minimum of 2 hours at weeks 0,2 and 6 to complete loading dose and then every 8 weeks during maintenance treatment period.

06

Study locations

1 site
  • Florida Academic Dermatology Center
    Miami, Florida 33143, United States
07

References and documents

Publications

  • Grant A, Gonzalez T, Montgomery MO, Cardenas V, Kerdel FA. Infliximab therapy for patients with moderate to severe hidradenitis suppurativa: a randomized, double-blind, placebo-controlled crossover trial. J Am Acad Dermatol. 2010 Feb;62(2):205-17. doi: 10.1016/j.jaad.2009.06.050. PubMed 20115947 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00795574
Lead sponsor
Florida Academic Dermatology Centers
First posted
Nov 21, 2008
Start date
Jun 2005
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Nov 24, 2008

Study contacts

Francisco A Kerdel, M.D
principal investigator · Florida Acadecmic Dermatology Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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