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NCT Number: NCT07067099

Neutralizing Interferon Type 1 in Hidradenitis Suppurativa

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.

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma with neutralizing autoantibodies to Type I Interferons

Biological

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

Primary outcomes

  1. Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies

    Time frame: within 28 days of infusion

    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).

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Etablissement Français du Sang

Registry information

Official study title

Use of Plasma With Neutralizing Autoantibodies to Type I Interferons in Patients With Severe Refractory Flare-up of Hidradenitis Suppurativa

Acronym: NIHS-I

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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