BTT1023 in Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Plaque Psoriasis - a Double-blind Randomized Placebo-controlled Sequential Group Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871598
• Other study ID #: BTT12-CD016
• 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

• Plaque Psoriasis
• Psoriasis

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