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New hope for painful skin condition? study cut short

NCT ID NCT06028230

Symptom relief Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new drug, SAR444656, in 70 adults with moderate to severe hidradenitis suppurativa (HS), a painful skin condition causing boils and abscesses. Participants took the drug or a placebo for 16 weeks to see if it reduced the number of inflamed nodules and abscesses. The study was terminated early, so results are limited.

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

70 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 2025

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 to 70 years

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: * Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline. * Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III. * Participant must have had an inadequate response after at least one-month of oral antibiotic treatment for HS, as assessed by the Investigator. * Participant must have a total AN count of ≥5 at the baseline visit. * Participant must have a draining tunnel count of ≤20 at the baseline visit. * Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol. * Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS. * Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline. * Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Participant with history of solid organ transplant. * Participant with history of splenectomy. * Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed. * Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS * Participant with family history of sudden death or long QT syndrome. * Participant with history of congenital or drug-induced long QT syndrome. * Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease. * Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening. * Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology. * Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication. * Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit. * Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions: * Discontinued due to treatment related toxicity and/or * Discontinuation is not related to lack or loss of therapeutic response. 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

Contacts and locations

Locations

  • ARA Professionals- Site Number : 8400023

    Miami, Florida, 33176-1032, United States

  • Advanced Dermatology and Cosmetic Care- Site Number : 8400025

    Valencia, California, 91355, United States

  • Beth Israel Deaconess Medical Center - 110 Francis St- Site Number : 8400013

    Boston, Massachusetts, 02215-5563, United States

  • Clear Dermatology & Aesthetics Center- Site Number : 8400006

    Scottsdale, Arizona, 85255, United States

  • Clinical Research Philadelphia,LLC- Site Number : 8400026

    Philadelphia, Pennsylvania, 19114-1025, United States

  • Clinical Trials Management Services - Thousand Oaks- Site Number : 8400028

    Thousand Oaks, California, 91360, United States

  • Cosmetic Dermatology of Orange County- Site Number : 8400024

    Anaheim, California, 92807, United States

  • Dawes Fretzin Clinical Research- Site Number : 8400011

    Indianapolis, Indiana, 46256, United States

  • Dermatology Specialists Research (DS Research) - Indiana- Site Number : 8400012

    Clarksville, Indiana, 47129, United States

  • Dermatology Specialists of Spokane- Site Number : 8400015

    Spokane, Washington, 99202-1332, United States

  • Encore Medical Research - 6600 Taft St- Site Number : 8400005

    Hollywood, Florida, 33024, United States

  • Encore Medical Research - Weston- Site Number : 8400010

    Weston, Florida, 33331, United States

  • Encore Medical Research of Boynton Beach- Site Number : 8400002

    Boynton Beach, Florida, 33436, United States

  • First OC Dermatology - Fountain Valley- Site Number : 8400007

    Fountain Valley, California, 92708-3701, United States

  • Investigational Site Number : 1240004

    Québec, Quebec, G1W 4R4, Canada

  • Investigational Site Number : 1520001

    Las Condes, 7580206, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520003

    Independencia, 8380000, Chile

  • Investigational Site Number : 1520004

    Temuco, 4810345, Chile

  • Investigational Site Number : 2760001

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Investigational Site Number : 2760002

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Investigational Site Number : 2760004

    Remscheid, North Rhine-Westphalia, 42897, Germany

  • Investigational Site Number : 2760005

    Berlin, 10789, Germany

  • Investigational Site Number : 2760006

    Würzburg, Bavaria, 97080, Germany

  • Investigational Site Number : 2760007

    Frankfurt am Main, Hesse, 60590, Germany

  • Investigational Site Number : 2760008

    Munich, Bavaria, 80337, Germany

  • Investigational Site Number : 2760009

    Dessau, Saxony-Anhalt, 06847, Germany

  • Investigational Site Number : 3000001

    Pavlos Melas, Thessaloniki, 564 29, Greece

  • Investigational Site Number : 3000002

    Thessaloniki, 546 43, Greece

  • Investigational Site Number : 3000003

    Athens, Attica, 12462, Greece

  • Investigational Site Number : 4100001

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Investigational Site Number : 4100002

    Cheonan-si, Chungcheongnam-do, 330721, South Korea

  • Investigational Site Number : 4100003

    Seongbuk-Gu, Seoul-teukbyeolsi, 02841, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 6160002

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Investigational Site Number : 6160004

    Ossy, Silesian Voivodeship, 42-624, Poland

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 90-436, Poland

  • Investigational Site Number : 6160006

    Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

  • Investigational Site Number : 6160007

    Katowice, Silesian Voivodeship, 40-040, Poland

  • Investigational Site Number : 7240001

    Granada, 18014, Spain

  • Investigational Site Number : 7240002

    Seville, 41009, Spain

  • Investigational Site Number : 7240003

    Alicante, 03010, Spain

  • Investigational Site Number : 7240004

    Cadiz, Cádiz, 11009, Spain

  • Investigational Site Number : 7240005

    Manises, Valencia, 46940, Spain

  • Moore Clinical Research - Brandon- Site Number : 8400001

    Brandon, Florida, 33511, United States

  • Paradigm Clinical Research - San Diego - ClinEdge - PPDS- Site Number : 8400021

    San Diego, California, 92108, United States

  • Revive Research Institute-1575 W Big Beaver Rd- Site Number : 8400008

    Troy, Michigan, 48084-3536, United States

  • Sullivan Dermatology- Site Number : 8400003

    Miami, Florida, 33162, United States

  • UPMC Montefiore- Site Number : 8400009

    Pittsburgh, Pennsylvania, 15213, United States

  • Vial Health - DermDox Dermatology- Site Number : 8400020

    Camp Hill, Pennsylvania, 17011, United States

  • Wayne Health - Dearborn- Site Number : 8400004

    Dearborn, Michigan, 48124-4085, United States

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