Atopic Dermatitis
Conditions
Interventions
Drug: KY1005
Pharmaceutical Form: Injection solution, Route of Administration: Subcutaneous
Drug: Placebo
Pharmaceutical Form: Injection solution,Route of Administration: Subcutaneous
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults (18 to = 4. - Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments. - Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline. - Able to complete patient questionnaires - Able and willing to comply with requested study visits / telephone and procedures. - Able and willing to provide written informed consent. - For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion criteria
Exclusion criteria: - Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy. - Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. - Weight 150 kg at Baseline. - Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline. - Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding. - Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured). - Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit. -Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease. -In the Investigator's opinion, any additional clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening Visit. -Concurrent participation in any other clinical study, including non-interventional studies. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage change in EASI (Eczema Area and Severity Index) from Baseline [ Time Frame: Baseline to Day 113 ] The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse event [ Time Frame: Baseline through Day 477 ] 2. Serum KY1005 concentration assessed throughout the study [ Time Frame: Baseline through Day 477 ] 3. Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169 [ Time Frame: Baseline to Day 169 ] The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition. 4. Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75) [ Time Frame: At Days 113 and 169 ] The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition. 5. Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline >= 2 points [ Time Frame: At Days 113 and 169 ] The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. 6. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) >= 4 with a baseline pruritus of >= 4 from baseline [ Time Frame: Days 113 and 169 ] The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being and 10 being the . 7. Absolute change from Baseline in EASI (Eczema Area and Severity Index) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ] The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition. 8. Percentage change from Baseline in EASI (Eczema Area and Severity Index) [ Time Frame: At Days 15, 29, 57, 85 and 141 ] The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicate worse condition. 9. Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50) [ Time Frame: At Days 15, 29, 57, 85, 113, 141 and 169 ] The EASI is a composite index with scores rang | — |
Countries
Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Study Unit
Sanofi K.K.
Outcome results
None listed