Neutralizing Interferon Type 1 in Hidradenitis Suppurativa

Phase 1Not Yet RecruitingNCT07067099

Centre Hospitalier Universitaire de Besancon6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hidradenitis Suppurativa (HS)

Interventions

Plasma with neutralizing autoantibodies to Type I InterferonsBIOLOGICAL

Transfusion of one unit of plasma containing high titre anti-IFN-1 autoantibodies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * IHS4 score ≥ 11 * Treatment of pain with opioids (≥ 20 mg/day) * Resistance to previous use (for at least 3 months) of systemic antibiotics and TNF inhibitors (infliximab or adalimumab) or anti-IL17 (secukinumab). * Vaccinations against SARS-CoV-2 and influenza up to date (or able to be carried out prior to the study procedure) * Women using an effective method of contraception * Signed informed consent Exclusion Criteria: * 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%) * Pregnant women * Subjects with no social security coverage

Locations (1)

CHU Besançon

Besançon, France

Outcomes

Primary Outcomes

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 infusion

Central Contacts

Charline Vauchy, PhD.

CONTACT

+33381218875 cvauchy@chu-besancon.fr

Data from ClinicalTrials.gov

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