drugset / Trial / NCT06686628
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25). The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.
Timeline
- Start
- 2024-11-20
- Primary completion
- 2025-11-21
- Completion
- 2026-04-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlitelimab | Monoclonal antibody | — | Subcutaneous |
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Metoprolol | Other / unclassified | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | Oral |
| Subject | Warfarin | Small molecule | — | Oral |