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

Sponsored by Sanofi

About this trial

Last updated 8 months ago

Study ID

ACT17841

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial 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

What are the participation requirements?

Yes

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.

No

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.