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BTT1023 in Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871598
First Posted: March 30, 2009
Last Update Posted: November 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biotie Therapies Corp.
  Purpose
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 Intervention Phase
Plaque Psoriasis Drug: BTT1023 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biotie Therapies Corp.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 12 weeks ]
  • Plasma concentrations of BTT1023 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ]

Enrollment: 26
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871598


Locations
Germany
Biotie investigational site
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
Sponsors and Collaborators
Biotie Therapies Corp.
  More Information

Responsible Party: CMO, Biotie Therapies, Biotie Therapies Corp.
ClinicalTrials.gov Identifier: NCT00871598     History of Changes
Other Study ID Numbers: BTT12-CD016
First Submitted: March 27, 2009
First Posted: March 30, 2009
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by Biotie Therapies Corp.:
plaque psoriasis
BTT1023
safety
pharmacokinetics

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases