Neutralizing Interferon Type 1 in Hidradenitis Suppurativa (NIHS-I)

Centre Hospitalier Universitaire de Besancon

Status and phase: Not yet enrolling; Phase 1

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Biological: Plasma with neutralizing autoantibodies to Type I Interferons

Study type: Interventional

Funder types: Other

Identifiers

NCT07067099

2024-A01035-42 (Other Identifier)

2024/871

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Patients with severe acute flare Hurley stage III HS

Experimental group

Description:

These patients present with refractory severe HS (Hurley stage III) flare treated with a transfusion of plasma containing high titre anti-IFN-1 auto-Antibodies.

Treatment:

Biological: Plasma with neutralizing autoantibodies to Type I Interferons