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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: SAR444656 (KT-474)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06028230

2023-504328-25 (Other Identifier)

ACT17841

U1111-1285-8790 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 3 patient groups, including a placebo group

SAR444656 dose 1

Experimental group

Description:

Participants will receive SAR444656 dose 1 orally

Treatment:

Drug: SAR444656 (KT-474)

SAR444656 dose 2

Experimental group

Description:

Participants will receive SAR444656 dose 2 orally

Treatment:

Drug: SAR444656 (KT-474)

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo