drugset / Trial / NCT02850965
Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis.
Timeline
- Start
- 2016-08-17
- Primary completion
- 2018-01-17
- Completion
- 2018-01-17
Publications
- Strand V. Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. Rheumatol Ther. 2025 Aug;12(4):613-616. doi: 10.1007/s40744-025-00766-6. Epub 2025 Jun 11.
- Strand V, McCabe D, Bender S. Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials. BMJ Open. 2024 Nov 17;14(11):e081687. doi: 10.1136/bmjopen-2023-081687.
- Menter A, Arenberger P, Balser S, Beissert S, Cauthen A, Czeloth N, Soung J, Jazayeri S, Weisenseel P, Jayadeva G. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. Expert Opin Biol Ther. 2021 Jan;21(1):87-96. doi: 10.1080/14712598.2021.1851362. Epub 2020 Dec 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | — | — |
| Subject | BI 695501 | Monoclonal antibody | — | — |