drugset / Trial / NCT05470114
A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
RandomizedParallel-groupDouble-blindTreatment
Summary
This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection. The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®. The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.
Timeline
- Start
- 2022-05-19
- Primary completion
- 2023-06-07
- Completion
- 2023-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dupilumab | Monoclonal antibody | — | Subcutaneous |
| Subject | TEMTOKIBART | Protein / enzyme biologic | — | Subcutaneous |