BTT1023 in Psoriasis

November 15, 2010 updated by: Biotie Therapies Corp.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12627
        • Biotie investigational site
      • Berlin, Germany, 14050
        • Biotie investigational site
      • Dresden, Germany, 01067
        • Biotie investigational site
      • Görlitz, Germany, 02826
        • Biotie investigational site
      • Leipzig, Germany, 04103
        • Biotie investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
intravenous, three infusions over three weeks
EXPERIMENTAL: Single 0.3
Drug: BTT1023
intravenous, three infusions over three weeks
Drug: BTT1023
Test challenge
EXPERIMENTAL: Repeat 1.0
Drug: BTT1023
intravenous, three infusions over three weeks
Drug: BTT1023
Test challenge
EXPERIMENTAL: Repeat 2.0
Drug: BTT1023
intravenous, three infusions over three weeks
Drug: BTT1023
Test challenge
EXPERIMENTAL: Repeat 4.0
Drug: BTT1023
intravenous, three infusions over three weeks
Drug: BTT1023
Test challenge
EXPERIMENTAL: Repeat 8.0
Drug: BTT1023
intravenous, three infusions over three weeks
Drug: BTT1023
Test challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 12 weeks
12 weeks
Plasma concentrations of BTT1023
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Psoriasis Area and Severity Index (PASI)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotie Therapies Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (ESTIMATE)

March 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2010

Last Update Submitted That Met QC Criteria

November 15, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTT12-CD016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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