drugset / Trial / NCT03331835
A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
RandomizedParallel-groupSingle-blindTreatment
Summary
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis. Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
Timeline
- Start
- 2017-11-03
- Primary completion
- 2019-01-24
- Completion
- 2019-03-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brodalumab | Monoclonal antibody | 210 mg | Subcutaneous |
| Comparator | dimethyl fumarate | Unknown | 120 mg | Oral |
| Comparator | ethyl hydrogen fumarate calcium salt | Unknown | 87 mg | Oral |
| Comparator | ethyl hydrogen fumarate magnesium salt | Unknown | 5 mg | Oral |
| Comparator | ethyl hydrogen fumarate zinc salt | Unknown | 3 mg | Oral |