Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis

Launched by SANOFI · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SAR444656 for adults with moderate to severe atopic dermatitis (AD), a chronic skin condition that causes itchy and inflamed skin. The trial aims to find out if this treatment can help people whose symptoms are not well controlled with standard topical therapies, such as creams and ointments. Participants will be randomly assigned to receive either SAR444656 in different doses or a placebo, which is a harmless pill that looks like the treatment but contains no active medicine. The study will last about 24 weeks, including a 4-week follow-up period after the treatment phase.

To be eligible for this trial, participants must be at least 18 years old, have a history of atopic dermatitis for over a year, and have moderate to severe symptoms as measured by specific scores. They should also have tried topical treatments without satisfactory results. Throughout the study, participants will be asked to keep a daily diary to track their symptoms. It's important to note that certain health conditions, like severe heart problems or recent major surgeries, may prevent someone from joining the trial. This study is currently recruiting participants, and individuals interested in joining should consult their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with atopic dermatitis as defined by the American Academy of Dermatology Consensus Criteria for at least 1 year before the baseline visit.
• • EASI ≥12 at screening and at baseline visit
• • vIGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visit.
• • AD involvement ≥10% of BSA at screening and baseline visit
• • Baseline PP-NRS ≥4
• • Participants must have documented history within 6 months prior to baseline visit, of either inadequate response or inadvisability to topical medications
• • Participants must have applied daily topical emollient (moisturizer) for at least the 7 consecutive days immediately before the baseline visit. Participants should continue using daily moisturizers during the study.
• • Participants must be willing and able to complete the electronic diary for the duration of the study as required by the study protocol.
• • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Exclusion Criteria:
• • Presence of other skin conditions that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus
• • Any active or chronic infection requiring systemic treatment within 4 weeks prior to baseline
• • Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminth infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
• • History of solid organ or stem cell transplant.
• • Participants with history of splenectomy.
• • Participants 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.
• • Family history of sudden death or long QT syndrome.
• • History of congenital or drug-induced long QT syndrome.
• • Congestive heart failure (NYHA Class 2-4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
• • 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.
• • History of ventricular fibrillation, ventricular tachycardia, Torsades de Pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
• • Uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mm Hg or consistent diastolic blood pressure ≥90 mm Hg despite antihypertensive medication.
• • Participants had major surgery within 4 weeks prior to the screening or have planned any elective major surgery during the study.
• • Having received any of protocol-specified prohibited therapy (Topical or systemic) within the specified timeframe prior to the baseline visit.
• • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.