1311.1 Safety, tolerability & efficacy of BI 655066 in psoriasis

• Research type

  Research Study

• Full title

  Safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of single rising i.v. (Stage 1) and s.c. (Stage 2) doses of BI 655066 in male and female patients with moderate to severe psoriasis (randomised, double-blind, placebo-controlled within dose groups).

• IRAS ID

  101738

• Contact name

  Joseph Chiesa

• Eudract number

  2012-000081-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT01577550

• Research summary

  This study is a first-in-human, phase I, single rising-dose, randomised, double-blind, placebo-controlled trial within dose groups in patients with moderate to severe psoriasis. Patients will be enrolled in two stages. Stage 1 patients will be given a single dose of BI 655066 or matching placebo intravenously (IV) in six sequential dose groups of four patients each. After completion of dosing in Stage 1, Stage 2 patients will receive one dose of BI 655066 or placebo given subcutaneously (SC), according to two parallel groups of seven patients each. Participation will involve 13 study visits to the research centre with one overnight stay over a 30 week period. Patients who have a diagnosis of moderate to severe psoriasis and are eligible may be considered for this study. The study will be performed by investigators specialized in this type of study. The study is sponsored by Boehringer Ingelheim, a pharmaceutical company.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0238

• Date of REC Opinion

  31 May 2012

• REC opinion

  Further Information Favourable Opinion