Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable
Summary
The primary objective of this study is to investigate the efficacy of nemolizumab administered in combination with topical background therapy (topical corticosteroids \[TCS\] with or without topical calcineurin inhibitors \[TCI\]) in adult participants with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with or are not advised to use oral cyclosporine A (CsA) for medical reasons. The secondary objective is to investigate the safety of nemolizumab in adult participants with moderate-to-severe AD who are not adequately controlled with or are not advised to use oral CsA for medical reasons. The study will be carried out in up to 70 different locations across Europe.
Timeline
- Start
- 2023-01
- Primary completion
- 2023-07
- Completion
- 2023-07
Outcome
Outcome not reported
Stopped: “The study data will not be utilized in the IND and is only being conducted in EU.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nemolizumab | Monoclonal antibody | 30 mg | Subcutaneous |