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Not yet recruiting NCT07067099

Neutralizing Interferon Type 1 in Hidradenitis Suppurativa

Phase I Interventional Hidradenitis Suppurativa (HS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma with neutralizing autoantibodies to Type I Interferons.
Who it may be relevant to
Registry conditions: Hidradenitis Suppurativa (HS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Biological Plasma with neutralizing autoantibodies to Type I Interferons
    Transfusion of one unit of plasma containing high titre anti-IFN-1 autoantibodies

Primary outcome measures

  • Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies [Time frame: within 28 days of infusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Besançon — Besançon

Identifiers

NCT: NCT07067099 · 2024/871 · 2024-A01035-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗