Dermatitis atopic MedDRA version: 20.0 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Amlitelimab
Product Code: SAR445229
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Amlitelimab
Current Sponsor code: SAR445229
Other descriptive name: KY1005
Concentra
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be 18 years of age, inclusive, or older at the time of signing the informed consent. - Participated in KY1005-CT05 (DRI17366) for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period, is still receiving investigational medicinal product (IMP) at the defined end of study for that participant and is from one of the following 3 cohorts: -- Cohort 1 - participants at Week 24 in the KY1005-CT05 (DRI17336) study who have not achieved an = Eczema Area and Skin Severity Index (EASI)-75 and/or Investigator Global Assessment (IGA) 0/1 -- Cohort 2 - participants at or after Week 28 and before Week 52 who lose clinical response. Loss of clinical response is defined as the first instance of =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Any participant who has received prohibited systemic therapies, as per KY1005-CT05 (DRI17366) clinical trial protocol, either during or after completion of KY1005-CT05 (DRI17366) participation will not be eligible for the ong-term extension (LTE) - Participants who, during their participation in KY1005-CT05 (DRI17366), developed an adverse events (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator or of the Medical Monitor could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant - Conditions in KY1005-CT05 (DRI17366), consistent with protocol-defined criteria for permanent IMP discontinuation, if deemed related to amlitelimab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). - Developed a medical condition that would preclude participation as per KY1005-CT05 (DRI17366) clinical trial protocol - Concurrent participation in any other clinical study, including non-interventional studies
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Percentage of participants who experienced treatment-emergent SAEs from baseline during the study 2)Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) from baseline during study 3)Absolute change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24 4)Percent change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24 5)Proportion of participants with EASI75/EASI90/EASI100 from KY1005-CT05 (DRI17366) baseline at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24 6)Proportion of participants with a response of investigator global assessment (IGA) 0 or 1and a reduction from baseline of =2 points at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24 7)Absolute change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study 8)Percent change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study 9)Proportion of participants with EASI50/EASI75/EASI90/EASI100 at pre-specified timepoints in all participants entering the study 10)Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTE entry in all participants entering the study 11)Time to first remission after LTE enrolment (achieving IGA 0/1) in those participants who had not achieved IGA 0/1 by the time of LTE entry in all participants entering the study 12)Proportion of participants with IGA score 0/1 at each visit in all participants entering the study 13)Proportion of participants with low disease activity state (e.g., IGA =2) at each visit in all participants entering the study 14)Proportion of participants requiring rescue treatment at each visit: all treatments in all participants enteri | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Characterize the safety of long-term treatment with amlitelimab in participants with atopic dermatitis (AD) ;Secondary Objective: -Additional characterization of safety of long-term treatment with amlitelimab in participants with AD -Characterize the efficacy of long-term treatment with amlitelimab in participants with AD -Characterize the pharmacokinetics profile of amlitelimab -Characterize the pharmacodynamic profile of amlitelimab ;Primary end point(s): Percentage of participants who experienced treatment-emergent adverse event (TEAE) from baseline during the study ;Timepoint(s) of evaluation of this end point: Baseline to Week 116 | — |
Countries
Australia, Bulgaria, Canada, Czechia, Czech Republic, Germany, Hungary, Japan, Poland, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed