EUCTR2021-002344-73-DE
Active, not recruiting
Phase 1
A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366).
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sanofi-aventis recherche & développement
- Enrollment
- 315
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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. Participants must only be enrolled
- •from 1 of the following 3 groups:
- •\-\- The first group: participants at Week 24 in the KY1005\-CT05
- •(DRI17336\) study who have not achieved an \= Eczema Area and Skin
- •Severity Index (EASI)\-75 and are Investigator Global Assessment (IGA)
- •2, 3 or 4\.
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria
- •\- 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\) will not be eligible for the longterm 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 could indicate that continued treatment with amlitelimab
- •may present an unreasonable risk for the participant
- •\- Conditions in KY1005\-CT05 (DRI17366\), consistent with protocoldefined criteria for permanent IMP discontinuation, if deemed related to
Outcomes
Primary Outcomes
Not specified
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