NCT01072383

Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis

A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Biotest · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.

Detailed description

Patients are enrolled into escalating dose levels. Improvement of PASI, physician's global assessment and itching score is evaluated after administration of BT061 or placebo. Safety data are assessed by an independent data and safety monitoring board (DSMB).

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	BT061	administration of BT061 either intravenous or subcutaneous
DRUG	placebo treatment	administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2010-02-22
• Last updated: 2012-03-13

Locations

13 sites across 2 countries: Czechia, Hungary