An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochro… (NCT06686628) | Clinical Trial Compass
CompletedPhase 1
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
Germany23 participantsStarted 2024-11-20
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* Male or female participant aged 18 to 65 years (inclusive), at the time of the informed consent is signed.
* Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria (2014) for 1 year or longer before signing of informed consent.
* The EASI score ≥16 at Screening and Check-in (Day -1).
* vIGA-AD score ≥3 (on the 0 to 4 vIGA-AD scale) at Screening and Check-in (Day -1).
* AD involvement of ≥10% body surface area at Screening and Check-in (Day -1).
* Participants must have documented history within 6 months prior to Screening and Check-in (Day -1), of either inadequate response (including inadequate efficacy or medical inadvisability) of topical treatments.
* Body weight within 40 to 150 kg at Screening and Day 1 and body mass index (BMI) \<40 kg/m2 (inclusive).
* Capable of giving signed informed consent.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic, or helminthic infections.
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline).
* Any concomitant illness that would, in the Investigator's opinion, inh…
What they're measuring
1
AUC and AUClast for CYP substrates
Timeframe: Baseline (Day 1 to Day 8) and Day 176 to Day 183