Case study

16 Dec 2020

Phase IIIb Trial in Adolescent Patients with Plaque Psoriasis


Overview

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


Challenges

  • 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.

See Other Case Studies

TFS involved in European global customer’s pre-lau...

TFS was requested to prepare and conduct a Late Phase global proposal to support the pre-launch activities of two pro...

Read more

How TFS Strategic Resourcing Solutions deployed a ...

Given the catastrophic spread of COVID-19, the search for safe and effective therapies has taken on an unpreced...

Read more

TFS & a Global Biotech Company

As clinical trials grow increasingly complex, timelines shorten, and R&D costs soar. Today’s biopharmaceuti...

Read more