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New hope for painful skin condition: experimental drug aims to reduce abscesses

NCT ID NCT07225569

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests an experimental drug called SAR445399 in 144 adults with moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes abscesses and tunnels under the skin. Participants will receive one of two doses of the drug or a placebo for 32 weeks. The main goal is to see if the drug can reduce the number of abscesses and inflamed bumps by at least 75% without worsening other symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III. * Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit. * Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history. * Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS. * History of recurrent or recent serious infection * Known history of or suspected current immunosuppression * History of solid organ transplant or stem cell transplant. * History of splenectomy * History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured. * Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    67 sites in 15 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advanced Clinical Research Institute- Site Number : 8400021

    RECRUITING

    Tampa, Florida, 33607, United States

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400017

    RECRUITING

    North Hollywood, California, 91606, United States

  • Centro de Pesquisas da Clínica IBIS- Site Number : 0760001

    RECRUITING

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Cleaver Medical Group Dermatology- Site Number : 8400008

    RECRUITING

    Cumming, Georgia, 30040, United States

  • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026

    RECRUITING

    Louisville, Kentucky, 40241, United States

  • Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Encore Medical Research - Hollywood- Site Number : 8400004

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Encore Medical Research of Boynton Beach- Site Number : 8400005

    RECRUITING

    Boynton Beach, Florida, 33436, United States

  • Equity Medical- Site Number : 8400010

    RECRUITING

    New York, New York, 10023, United States

  • Essential Medical Research- Site Number : 8400015

    RECRUITING

    Overland Park, Kansas, 66213, United States

  • FXM Clinical Research - Fort Lauderdale- Site Number : 8400013

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • First Georgia Physician Group- Site Number : 8400033

    RECRUITING

    Fayetteville, Georgia, 30214, United States

  • Florida International Research Center- Site Number : 8400002

    RECRUITING

    Miami, Florida, 33173, United States

  • Florida Research Center- Site Number : 8400009

    RECRUITING

    Miami, Florida, 33174, United States

  • Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014

    RECRUITING

    Miami, Florida, 33146, United States

  • Investigational Site Number : 0320001

    RECRUITING

    Buenos Aires, 1023, Argentina

  • Investigational Site Number : 0320002

    RECRUITING

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 0360001

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • Investigational Site Number : 0560001

    RECRUITING

    Ghent, 9000, Belgium

  • Investigational Site Number : 0560002

    RECRUITING

    Brussels, 1070, Belgium

  • Investigational Site Number : 0560004

    RECRUITING

    Liège, 4000, Belgium

  • Investigational Site Number : 1240002

    RECRUITING

    Sherbrooke, Quebec, J1G 1X9, Canada

  • Investigational Site Number : 1240010

    RECRUITING

    Montreal, Quebec, H1Y 3L1, Canada

  • Investigational Site Number : 1240011

    RECRUITING

    Saskatoon, Saskatchewan, S7K 0H6, Canada

  • Investigational Site Number : 1240013

    RECRUITING

    Regina, Saskatchewan, S4V 1R9, Canada

  • Investigational Site Number : 1240014

    RECRUITING

    Toronto, Ontario, M2N 3A6, Canada

  • Investigational Site Number : 1560001

    RECRUITING

    Beijing, 100730, China

  • Investigational Site Number : 1560002

    RECRUITING

    Wuhan, 430022, China

  • Investigational Site Number : 1560003

    RECRUITING

    Changsha, 410011, China

  • Investigational Site Number : 1560004

    RECRUITING

    Shanghai, 200040, China

  • Investigational Site Number : 2500002

    RECRUITING

    Nantes, 44093, France

  • Investigational Site Number : 2500003

    RECRUITING

    Rouen, 76031, France

  • Investigational Site Number : 2500004

    RECRUITING

    Paris, 75010, France

  • Investigational Site Number : 2500005

    RECRUITING

    Lille, 59020, France

  • Investigational Site Number : 2500006

    RECRUITING

    Lille, 59037, France

  • Investigational Site Number : 2760002

    RECRUITING

    Rostock, 18055, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Regensburg, 93053, Germany

  • Investigational Site Number : 2760004

    RECRUITING

    Blankenfelde-Mahlow, 15831, Germany

  • Investigational Site Number : 2760005

    RECRUITING

    Merzig, 66663, Germany

  • Investigational Site Number : 2760007

    RECRUITING

    Darmstadt, 64283, Germany

  • Investigational Site Number : 3480002

    RECRUITING

    Budapest, 1085, Hungary

  • Investigational Site Number : 3480003

    RECRUITING

    Kaposvár, 7400, Hungary

  • Investigational Site Number : 3480004

    RECRUITING

    Szeged, 6720, Hungary

  • Investigational Site Number : 3480005

    RECRUITING

    Gyula, 5700, Hungary

  • Investigational Site Number : 3800001

    RECRUITING

    Chieti, 66100, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Torette, Ancona, 60020, Italy

  • Investigational Site Number : 3800003

    RECRUITING

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800004

    RECRUITING

    Brescia, 25123, Italy

  • Investigational Site Number : 3800005

    RECRUITING

    Cona, Ferrara, 44124, Italy

  • Investigational Site Number : 3800006

    RECRUITING

    Pisa, 56126, Italy

  • Investigational Site Number : 3920001

    RECRUITING

    Tokyo, 173-8610, Japan

  • Investigational Site Number : 3920002

    RECRUITING

    Tokyo, 160-0023, Japan

  • Investigational Site Number : 7240001

    RECRUITING

    Córdoba, 14004, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Bilbao, Basque Country, 48013, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Málaga, 29016, Spain

  • Investigational Site Number : 7240005

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Investigational Site Number : 7240006

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7520001

    RECRUITING

    Örebro, 701 85, Sweden

  • Investigational Site Number : 7520002

    RECRUITING

    Uppsala, 752 37, Sweden

  • Investigational Site Number : 7920001

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    RECRUITING

    Manisa, 45030, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    RECRUITING

    Samsun, 55139, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    RECRUITING

    Izmir, 35540, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    RECRUITING

    Buca, 35390, Turkey (Türkiye)

  • Scottsdale Clinical Trials- Site Number : 8400006

    RECRUITING

    Scottsdale, Arizona, 85260, United States

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