BTT1023 in Psoriasis
- Registration Number
- NCT00871598
- Lead Sponsor
- Biotie Therapies Corp.
- Brief Summary
Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index
Exclusion Criteria
- Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection;
- Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry;
- An absolute indication for a known effective treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Repeat 2.0 BTT1023 - Placebo Placebo - Single 0.3 BTT1023 - Repeat 4.0 BTT1023 - Repeat 1.0 BTT1023 - Repeat 8.0 BTT1023 -
- Primary Outcome Measures
Name Time Method Adverse events 12 weeks Plasma concentrations of BTT1023 12 weeks
- Secondary Outcome Measures
Name Time Method Change in Psoriasis Area and Severity Index (PASI) 12 weeks
Trial Locations
- Locations (2)
Biotie investigational site
🇩🇪Leipzig, Germany
Biotie Investigational Site
🇩🇪Görlitz, Germany