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BTT1023 in Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BTT1023
Placebo
BTT1023
Sponsored by
Biotie Therapies Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring plaque psoriasis, BTT1023, safety, pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Biotie investigational site
  • Biotie investigational site
  • Biotie investigational site
  • Biotie Investigational Site
  • Biotie investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Single 0.3

Repeat 1.0

Repeat 2.0

Repeat 4.0

Repeat 8.0

Arm Description

Outcomes

Primary Outcome Measures

Adverse events
Plasma concentrations of BTT1023

Secondary Outcome Measures

Change in Psoriasis Area and Severity Index (PASI)

Full Information

First Posted
March 27, 2009
Last Updated
November 15, 2010
Sponsor
Biotie Therapies Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00871598
Brief Title
BTT1023 in Psoriasis
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biotie Therapies Corp.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
plaque psoriasis, BTT1023, safety, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Single 0.3
Arm Type
Experimental
Arm Title
Repeat 1.0
Arm Type
Experimental
Arm Title
Repeat 2.0
Arm Type
Experimental
Arm Title
Repeat 4.0
Arm Type
Experimental
Arm Title
Repeat 8.0
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BTT1023
Intervention Description
intravenous, three infusions over three weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenous, three infusions over three weeks
Intervention Type
Drug
Intervention Name(s)
BTT1023
Intervention Description
Test challenge
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
12 weeks
Title
Plasma concentrations of BTT1023
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Biotie investigational site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Biotie investigational site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Biotie investigational site
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Biotie Investigational Site
City
Görlitz
ZIP/Postal Code
02826
Country
Germany
Facility Name
Biotie investigational site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

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BTT1023 in Psoriasis

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