NCT06686628

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis Atopic

Interventions

Type	Name	Description
DRUG	Amlitelimab	Pharmaceutical form: Injection solution Route of administration: SC injection
DRUG	Midazolam	Pharmaceutical form: Solution Route of administration: Oral
DRUG	Caffeine	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Metoprolol	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Omeprazole	Pharmaceutical form: Capsule Route of administration: Oral
DRUG	Warfarin	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-11-21
• Completion: 2026-04-03
• First posted: 2024-11-13
• Last updated: 2026-01-29

Locations

1 site across 1 country: Germany