Plaque Psoriasis
Conditions
Keywords
plaque psoriasis, BTT1023, safety, pharmacokinetics
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.
Interventions
DRUGBTT1023
intravenous, three infusions over three weeks
DRUGPlacebo
intravenous, three infusions over three weeks
Sponsors
Biotie Therapies Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | 12 weeks |
| Plasma concentrations of BTT1023 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Psoriasis Area and Severity Index (PASI) | 12 weeks |
Countries
Germany
Outcome results
None listed