16 Dec 2020
Phase IIIb Trial in Adolescent Patients with Plaque Psoriasis
As part of our experience in this indication, TFS is proud to present a case study of a Phase IIIb trial we conducted in adolescent patients with plaque psoriasis. This case study demonstrates our knowledge of this indication and the value we add to the trials we conduct.
- Study Phase: IIIb
- Indication: Plaque psoriasis
- Number of patents: 130
- Sites: 20
- Services: Full Service
- The study involved adolescents and therefore increased challenges for patient recruitment.
- There have been Progressive Multifocal Leukoencephalopathy (PML) cases during therapy with Fumaric Acid Esters (FAEs) – an ongoing worldwide discussion and possible safety concerns of this treatment lead to uncertainty around monitoring rules.
- There was a competitive environment with significant numbers of psoriasis studies ongoing.
- Certain drug characteristics (slow onset of action, gastrointestinal symptoms, flushing) and monitoring rules required explanation to physicians and patients.
- There was a highly competitive treatment landscape with several biologics available (including some with ‘’first line label”) with strong sales force and remarkable efficacy data and a rapid onset of efficacy compared to FAEs.
- There was a high dropout rate due to placebo and GI symptoms.