Neutralizing Interferon Type 1 in Hidradenitis Suppurativa

NCT ID: NCT07067099

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Hidradenitis Suppurativa (HS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with severe acute flare Hurley stage III HS

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.

Group Type: EXPERIMENTAL

Plasma with neutralizing autoantibodies to Type I Interferons

Intervention Type: BIOLOGICAL

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

Interventions

Plasma with neutralizing autoantibodies to Type I Interferons

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Etablissement Français du Sang

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Besançon

Besançon, , France

Countries

France

Central Contacts

Charline Vauchy, PhD.

Role: CONTACT

cvauchy@chu-besancon.fr

+33381218875

Other Identifiers

2024-A01035-42

Identifier Type: OTHER

Identifier Source: secondary_id

2024/871

Identifier Type: -

Identifier Source: org_study_id