Atopic Dermatitis Eczema
Conditions
Interventions
SAR443726
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: PDY16891: - Confirmed diagnosis of moderate-to-severe AD for at least 1 year prior to first administration of IMP on Day 1 - Quantiferon® - tuberculosis (TB) Gold test must be negative with no prior history of documented tuberculosis irrespective of treatment. - Eczema Area and Severity Index (EASI) score * 12 at screening and * 16 at Baseline - Validated IGA score of at least 3 or 4 at Baseline - Atopic dermatitis involvement of *10% of BSA at Baseline - Normal or clinically acceptable vital signs, standard 12-lead ECG parameters, laboratory parameters within the normal range - Body weight between 50.0 and 105.0 kg, inclusive, if male, and between 45.0 and 95.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/m2, inclusive - Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments - Participants should make every effort to apply a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) on lesional area at least twice daily for at least 7 consecutive days before Baseline. - Male participants must accept to use, during sexual intercourse, a double contraception method. - A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a woman of nonchildbearing potential (WONCBP) ORIs a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective
Exclusion criteria
Exclusion criteria: PDY16891: - Presence of dermatologic diseases other than AD that are susceptible to interfere with clinical assessment of AD. - Co-morbid clinically significant disease that might interfere with the evaluation of IMP (eg. but not limited to: uncontrolled diabetes, severe hypertension, severe ischemic heart disease, unstable angina in the last 6 months, unstable cardiac arrhythmias, and Class IV heart failure, renal, hepatic or pulmonary disease, neurological condition, cancer any type). Controlled hypertension under stable (unchanged in the last 6 months) treatment with 1 antihypertensive is allowed. - Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics, or antiprotozoals within 4 weeks before Screening visit, significant viral infections within 4 weeks before Screening visit that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment). - Participants with autoimmune disease or using systemic immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc). - Significant blood loss (including blood donation [>450 mL] or plasma donation [>200 mL], within 2 months prior to Screening. - Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure *30 mmHg within 3 minutes when changing from supine to standing position. - Presence or history of drug hypersensitivity, or relevant allergic disease diagnosed and treated by a physician. Participants with a history of mild seasonal allergies may be included at investigator discretion. - History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). - Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution; or unusually frequent, recurrent or prolonged infections, per Investigator's judgment. - Diagnosed active parasitic infection (helminths), suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization. - Any prior history of malignancy or active malignancy, including lymphoproliferative diseases (except successfully treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin) within 5 years prior to Screening visit. - Treatment with TCS/TCI within 2 weeks prior to Baseline or systemic corticosteroids within 4 weeks prior to Baseline for the management of AD. - Treatment with phototherapy within 2 weeks prior to Baseline for the management of AD. - Exposure to investigational therapies (excluding biologics) within 3 months prior to Baseline. - Any recall vaccination with non-live vaccines including recall vaccination for COVID-19 within the last 4 weeks before first IMP administration (Day 1). - Administration of a live attenuated virus vaccine within 3 months before Baseline/first IMP administration (Day 1). - Ini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Assessment of AEs /TEAEs * Clinical laboratory evaluations (hematology, biochemistry, coagulation, urinalysis) * Vital signs * Electrocardiogram intervals (heart rate, PR, QRS, QT, QTcF) derived from 12-lead ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| * Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 [Main Secondary Endpoint] * Percent change from baseline in EASI score from Week 2 to Week 16 and from Week 18 until Week 22 * Percentage of participants with at least a 50% reduction from baseline in EASI score (EASI-50) from Week 2 to Week 16 and from Week 18 until Week 22 * Percentage of participants with at least a 75% reduction from baseline in EASI (EASI-75) from Week 2 to Week 16 and from Week 18 until Week 22 * Percentage of participants with at least a 90% reduction from baseline in EASI (EASI-90) from Week 2 to Week 16 and from Week 18 until Week 22 * Change from baseline in validated Investigator Global Assessment (vIGA) from Week 2 to Week 16 and from Week 18 until Week 22 * Percentage of patients reaching vIGA score 0 or 1 and a reduction from baseline *2 points from Week 2 to Week 16 and from Week 18 until Week 22 * Change from baseline in SCORing of Atopic Dermatitis (SCORAD) Index from Week 2 to Week 16 and from Week 18 until Week 22 * Change from baseline in BSA of AD lesions from Week 2 to Week 16 and from Week 18 until Week 22 * Change from baseline in Dermatology Quality of Life Index (DLQI) from Week 2 to Week 16 and from Week 18 until Week 22 * Change from baseline in daily peak Pruritus Numerical Rating Scale (NRS) score from Week 2 to Week 16 and from Week 18 until Week 22 * Change (absolute and percent) from baseline in weekly average of daily peak pruritus NRS from Week 2 to Week 16 and from Week 18 until Week 22 * Time to onset of effect on pruritus (*4-point reduction in weekly average of daily peak Pruritus NRS from baseline) * Change from baseline in Patient Oriented Eczema Measure (POEM) score from Week 2 to Week 16 and from Week 18 until Week 22 * Change from baseline in Atopic Dermatitis Control Tool (ADCT) score from Week 2 to Week 16 and from Week 18 until Week 22 * Descriptive statistics on serum concentrations at | — |
Countries
Netherlands
Outcome results
None listed