Home › Trials › NCT06028230

Evaluating SAR444656 for treating moderate to severe Hidradenitis Suppurativa

A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Phase 2 Interventional Sanofi · NCT06028230

This study is testing a new medication called SAR444656 to see if it can help adults with moderate to severe Hidradenitis Suppurativa feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment156 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorSanofi Industry-sponsored
Locations41 sites (Scottsdale, Arizona and 40 other locations)
Trial IDNCT06028230 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial aims to assess the efficacy and safety of SAR444656 compared to a placebo in adults aged 18 to 70 with moderate to severe Hidradenitis Suppurativa (HS). Participants will undergo a screening period of up to 4 weeks, followed by a treatment phase lasting up to 16 weeks, and a follow-up period of 4 weeks. The study involves 14 visits and includes individuals with a history of HS and inadequate response to previous treatments. The trial will evaluate the drug's pharmacokinetics and biological effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a history of moderate to severe Hidradenitis Suppurativa and inadequate response to prior antibiotic treatments.

Not a fit: Patients with other active skin diseases or conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe Hidradenitis Suppurativa, enhancing patients' quality of life.

How similar studies have performed: Other studies have shown promise in treating Hidradenitis Suppurativa with similar therapeutic approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis Suppurativa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.