Neutralizing Interferon Type 1 in Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa (HS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon
About this trial
The purpose of the study is to evaluate the safety and type 1 Interferon (IFN) neutralization in patients with refractory severe Hidradenitis Suppurativa (Hurley stage III) after transfusion of plasma containing high titer anti-IFN-1 autoantibodies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged over 18
Patients with Hidradenitis suppurativa (Hurley stages II-III)
Disease affecting at least two distinct anatomical areas,
Total count of abscesses (A) and inflammatory nodules (N) ≥ 3
Disqualifiers
Active viral infection: herpes, VZV, HIV, HBV, HCV
Active bacterial infection requiring systemic antibiotics
Known allergy to blood components/plasma proteins
Poor myocardial function (increased risk of for transfusion-associated circulatory overload) (symptomatic left ventricular failure and ejection fraction < 40%)
Trial design
Design model
Single group
Treatments tested in this trial
Plasma with neutralizing autoantibodies to Type I Interferons
Biological/VaccineTransfusion of one unit of plasma containing high titre anti-IFN-1 autoantibodies
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Patients with severe acute flare Hurley stage III HSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies
Two aspects are considered when assessing safety: * Immediate serious adverse events (SAEs) (within 24 hours of infusion) and, * Delayed SAEs (within 28 days of infusion). Adverse events are coded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE V5.0).
Time frame
within 28 days of infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Besancon
Lead sponsor
Etablissement Français du Sang
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: