Neutralizing Interferon Type 1 in Hidradenitis Suppurativa

NCT07067099 | Not Yet Recruiting Phase 1

• 2 other identifiers: 2024/8712024-A01035-42
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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)

Keywords

Plasma therapy; Neutralizing type-1 interferon autoantibodies

Outcome Measures

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).

  within 28 days of infusion

Study Arms (1)

Patients with severe acute flare Hurley stage III HS

EXPERIMENTAL

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.

Biological: Plasma with neutralizing autoantibodies to Type I Interferons

Interventions

Plasma with neutralizing autoantibodies to Type I Interferons BIOLOGICAL

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

Patients with severe acute flare Hurley stage III HS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Etablissement Français du Sang: collaborator

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Charline Vauchy, PhD.

CONTACT

+33381218875; cvauchy@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

FR (1)