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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00871598
Other study ID # BTT12-CD016
Secondary ID
Status Completed
Phase Phase 1
First received March 27, 2009
Last updated November 15, 2010
Start date March 2009
Est. completion date August 2010

Study information

Verified date November 2010
Source Biotie Therapies Corp.
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
BTT1023
intravenous, three infusions over three weeks
Placebo
intravenous, three infusions over three weeks
BTT1023
Test challenge

Locations

Country Name City State
Germany Biotie investigational site Berlin
Germany Biotie investigational site Berlin
Germany Biotie investigational site Dresden
Germany Biotie Investigational Site Görlitz
Germany Biotie investigational site Leipzig

Sponsors (1)

Lead Sponsor Collaborator
Biotie Therapies Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events 12 weeks Yes
Primary Plasma concentrations of BTT1023 12 weeks No
Secondary Change in Psoriasis Area and Severity Index (PASI) 12 weeks No
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