Neutralizing Interferon Type 1 in Hidradenitis Suppurativa

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07067099

Acronym

NIHS-I

Enrollment

Registered

2025-07-16

Start date

2025-09-30

Completion date

2026-09-30

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Plasma therapy, Neutralizing type-1 interferon autoantibodies

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.

Interventions

BIOLOGICALPlasma with neutralizing autoantibodies to Type I Interferons

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies	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).

Countries

France

Contacts

Primary ContactCharline Vauchy, PhD.

cvauchy@chu-besancon.fr+33381218875

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026