BTT1023 in Psoriasis

Sponsor

Biotie Therapies Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT00871598

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: BTT1023 Drug: Placebo Drug: BTT1023	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo intravenous, three infusions over three weeks
Experimental: Single 0.3	Drug: BTT1023 Test challenge
Experimental: Repeat 1.0	Drug: BTT1023 intravenous, three infusions over three weeks
Experimental: Repeat 2.0	Drug: BTT1023 intravenous, three infusions over three weeks
Experimental: Repeat 4.0	Drug: BTT1023 intravenous, three infusions over three weeks
Experimental: Repeat 8.0	Drug: BTT1023 intravenous, three infusions over three weeks

Outcome Measures

Primary Outcome Measures

Adverse events [12 weeks]
Plasma concentrations of BTT1023 [12 weeks]

Secondary Outcome Measures

Change in Psoriasis Area and Severity Index (PASI) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Biotie investigational site	Berlin	Germany	12627
2	Biotie investigational site	Berlin	Germany	14050
3	Biotie investigational site	Dresden	Germany	01067
4	Biotie Investigational Site	Görlitz	Germany	02826
5	Biotie investigational site	Leipzig	Germany	04103