Phase 2 study of SAR444656 in adult participants with moderate to severe atopic dermatitis.

Phase 1

Recruiting

• Conditions: Dermatitis atopic; MedDRA version: 20.0Level: PTClassification code: 10012438Term: Dermatitis atopic Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-504346-66-00
• Lead Sponsor: Sanofi-Aventis Recherche & Developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 177

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., Participant 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., Participant 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., 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., Bradycardia with heart rate <50 beats per minute during screening., Supine 12-lead triplicate ECG demonstrating a mean QTcF interval >440 msec or QRS interval >110 msec in ECG obtained during screening., Serum potassium, magnesium, or calcium below lower limit of normal during screening., Participants had major surgery within 4 weeks prior to the screening or have planned any elective major surgery during the study., 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., 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., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of SAR444656 on AD lesions compared with placebo in adult participants with moderate to severe AD.;Secondary Objective: To assess the efficacy of SAR444656 on additional clinical assessments of AD compared with placebo in adult participants with moderate to severe AD., To assess the efficacy of SAR444656 on patients reported outcomes (PRO) compared with placebo in adult participants with moderate to severe AD., To assess the safety of SAR444656 in adult participants with moderate to severe AD., To assess the pharmacokinetic profile of SAR444656 in adult participants with moderate to severe AD.;Primary end point(s): Percent change from baseline in EASI.