BTT1023 in Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Biotie Therapies Corp.
ClinicalTrials.gov Identifier:
NCT00871598
First received: March 27, 2009
Last updated: November 15, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of BTT1023 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871598

Locations
Germany
Biotie investigational site
Berlin, Germany, 14050
Biotie investigational site
Berlin, Germany, 12627
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

No publications provided

Responsible Party: CMO, Biotie Therapies, Biotie Therapies Corp.
ClinicalTrials.gov Identifier: NCT00871598     History of Changes
Other Study ID Numbers: BTT12-CD016
Study First Received: March 27, 2009
Last Updated: November 15, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on September 15, 2014