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OpenTrials
Completed

NCT Number: NCT00871598

BTT1023 in Psoriasis

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotie investigational site, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTT1023

Drug

intravenous, three infusions over three weeks

Placebo

Drug

intravenous, three infusions over three weeks

Primary outcomes

  1. Adverse events

    Time frame: 12 weeks

  2. Plasma concentrations of BTT1023

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Psoriasis Area and Severity Index (PASI)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Biotie Therapies Corp.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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