Hidradenitis Suppurativa (HS)Phase 1NIHS-INCT07067099
Neutralizing Interferon Type 1 in Hidradenitis Suppurativa
A Phase 1 study testing Plasma with neutralizing autoantibodies to Type I Interferons in people with Hidradenitis Suppurativa (HS), run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Plasma with neutralizing autoantibodies to Type I Interferons
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of Plasma With Neutralizing Autoantibodies to Type I Interferons in Patients With Severe Refractory Flare-up of 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Plasma with neutralizing autoantibodies to Type I Interferons
- Keywords
- Plasma therapy, Neutralizing type-1 interferon autoantibodies
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma with neutralizing autoantibodies to Type I InterferonsBiological
Transfusion of one unit of plasma containing high titre anti-IFN-1 autoantibodies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Plasma with neutralizing autoantibodies to Type I Interferons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 28 days of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067099
- Sponsor's protocol ID
- 2024/871
- Other IDs
- 2024-A01035-42
- Acronym
- NIHS-I
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Plasma With Neutralizing Autoantibodies to Type I Interferons in Patients With Severe Refractory Flare-up of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07067099
- Acronym / sponsor ID
- NIHS-I / 2024/871
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Plasma therapy, Neutralizing type-1 interferon autoantibodies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe acute flare Hurley stage III HS | Experimental | Biological: Plasma with neutralizing autoantibodies to Type I InterferonsThese patients present with refractory severe HS (Hurley stage III) flare treated with a transfusion of plasma containing high titre anti-IFN-1 auto-Antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma with neutralizing autoantibodies to Type I InterferonsTransfusion of one unit of plasma containing high titre anti-IFN-1 autoantibodies | Biological | Patients with severe acute flare Hurley stage III HS |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plasma with neutralizing autoantibodies to Type I Interferons in people with Hidradenitis Suppurativa (HS), run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charline Vauchy, PhD. (+33381218875, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of transfusion of plasma containing high titer anti-IFN-1 auto-Antibodies (time frame: within 28 days of infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.