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Hidradenitis SuppurativaPhase 2ZENNCT06028230

A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 2 study testing SAR444656 (KT-474) in people with Hidradenitis Suppurativa, run by Sanofi at 52 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
SAR444656 (KT-474)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
52 sitesin 8 countries
Study dates
29 Sep 2023to 12 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

52 sites in 8 countries.

52 sites in 8 countries

United States21 sites

  • Cosmetic Dermatology of Orange County- Site Number : 8400024

    Anaheim, California, 92807

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

    Boston, Massachusetts, 02215-5563

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

    Boynton Beach, Florida, 33436

  • Moore Clinical Research - Brandon- Site Number : 8400001

    Brandon, Florida, 33511

  • Vial Health - DermDox Dermatology- Site Number : 8400020

    Camp Hill, Pennsylvania, 17011

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

    Clarksville, Indiana, 47129

  • Wayne Health - Dearborn- Site Number : 8400004

    Dearborn, Michigan, 48124-4085

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

    Fountain Valley, California, 92708-3701

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

    Hollywood, Florida, 33024

  • Dawes Fretzin Clinical Research- Site Number : 8400011

    Indianapolis, Indiana, 46256

  • Sullivan Dermatology- Site Number : 8400003

    Miami, Florida, 33162

  • ARA Professionals- Site Number : 8400023

    Miami, Florida, 33176-1032

  • Clinical Research Philadelphia,LLC- Site Number : 8400026

    Philadelphia, Pennsylvania, 19114-1025

  • UPMC Montefiore- Site Number : 8400009

    Pittsburgh, Pennsylvania, 15213

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

    San Diego, California, 92108

  • Clear Dermatology & Aesthetics Center- Site Number : 8400006

    Scottsdale, Arizona, 85255

  • Dermatology Specialists of Spokane- Site Number : 8400015

    Spokane, Washington, 99202-1332

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

    Thousand Oaks, California, 91360

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

    Troy, Michigan, 48084-3536

  • Advanced Dermatology and Cosmetic Care- Site Number : 8400025

    Valencia, California, 91355

  • Encore Medical Research - Weston- Site Number : 8400010

    Weston, Florida, 33331

Other trials in United States

Germany8 sites

  • Investigational Site Number : 2760005

    Berlin, 10789

  • Investigational Site Number : 2760001

    Bochum, North Rhine-Westphalia, 44791

  • Investigational Site Number : 2760009

    Dessau, Saxony-Anhalt, 06847

  • Investigational Site Number : 2760007

    Frankfurt am Main, Hesse, 60590

  • Investigational Site Number : 2760002

    Heidelberg, Baden-Wurttemberg, 69120

  • Investigational Site Number : 2760008

    Munich, Bavaria, 80337

  • Investigational Site Number : 2760004

    Remscheid, North Rhine-Westphalia, 42897

  • Investigational Site Number : 2760006

    Würzburg, Bavaria, 97080

Other trials in Germany

Poland6 sites

  • Investigational Site Number : 6160007

    Katowice, Silesian Voivodeship, 40-040

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 90-436

  • Investigational Site Number : 6160004

    Ossy, Silesian Voivodeship, 42-624

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 00-874

  • Investigational Site Number : 6160006

    Wroclaw, Lower Silesian Voivodeship, 50-449

  • Investigational Site Number : 6160002

    Wroclaw, Lower Silesian Voivodeship, 50-566

Other trials in Poland

Spain5 sites

  • Investigational Site Number : 7240003

    Alicante, 03010

  • Investigational Site Number : 7240004

    Cadiz, Cádiz, 11009

  • Investigational Site Number : 7240001

    Granada, 18014

  • Investigational Site Number : 7240005

    Manises, Valencia, 46940

  • Investigational Site Number : 7240002

    Seville, 41009

Other trials in Spain

Chile4 sites

  • Investigational Site Number : 1520003

    Independencia, 8380000

  • Investigational Site Number : 1520001

    Las Condes, 7580206

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520004

    Temuco, 4810345

Other trials in Chile

South Korea4 sites

  • Investigational Site Number : 4100002

    Cheonan-si, Chungcheongnam-do, 330721

  • Investigational Site Number : 4100003

    Seongbuk-Gu, Seoul-teukbyeolsi, 02841

  • Investigational Site Number : 4100001

    Seongnam-si, Gyeonggi-do, 13496

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03080

Other trials in South Korea

Greece3 sites

  • Investigational Site Number : 3000003

    Athens, Attica, 12462

  • Investigational Site Number : 3000001

    Pavlos Melas, Thessaloniki, 564 29

  • Investigational Site Number : 3000002

    Thessaloniki, 546 43

Other trials in Greece

Canada1 site

  • Investigational Site Number : 1240004

    Québec, Quebec, G1W 4R4

Other trials in Canada

About this study

Official title: 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

This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years.

Study details include:

  • Screening period: up to 4 weeks (30 days)
  • Treatment duration: up to 16 weeks
  • Follow-up period: up to 4 weeks
  • Total study duration: up to 24 weeks
  • Number of visits: 14
Being tested
SAR444656 (KT-474), Placebo
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR444656 (KT-474)Drug

    Oral Tablet

  • PlaceboDrug

    Oral Tablet

Study groups in NCT06028230
Study groupRoleWhat they receive
SAR444656 dose 1ExperimentalParticipants will receive SAR444656 dose 1 orally
Receives: Drug: SAR444656 (KT-474)
SAR444656 dose 2ExperimentalParticipants will receive SAR444656 dose 2 orally
Receives: Drug: SAR444656 (KT-474)
PlaceboPlacebo comparatorParticipants will receive placebo orally
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in total abscess and inflammatory nodule (AN) count

    The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts obtained as part of the HS clinical parameters.

    Measured: Week 16

Secondary outcomes (10)

  1. Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)

    Measured: Week 16

  2. Proportion of participants achieving AN count ≤2

    Measured: Week 16

  3. Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)

    Measured: Week 16

  4. Proportion of participants with improvement from baseline in Hurley Stage

    Measured: Week 16

  5. Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)

    Measured: Week 16

  6. Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)

    Measured: Week 16

  7. Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS

    Measured: Week 16

  8. Change from baseline in the amount of analgesic

    Measured: Up to Week 16

  9. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs

    Measured: Up to Week 20

  10. Plasma SAR444656 concentration

    Measured: Up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start29 Sep 2023
  3. Primary completion9 Oct 2025
  4. Study completion12 Nov 2025

Why it stopped: Sponsor decision. Not related to safety concern.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028230
Sponsor's protocol ID
ACT17841
Other IDs
2023-504328-25, U1111-1285-8790, 2023
Acronym
ZEN
Status last verified
Dec 2025
First submitted
31 Aug 2023
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR444656 (KT-474) in people with Hidradenitis Suppurativa, run by Sanofi at 52 sites in 8 countries.

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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Germany, Poland, Spain, Chile and 3 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision. Not related to safety concern.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in total abscess and inflammatory nodule (AN) count (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028230.

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 11 Dec 2025.

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ZEN Clinical Trial NCT06028230 | AzTrials