NCT00871598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

1.4 years

First QC Date

March 27, 2009

Last Update Submit

November 15, 2010

Conditions

Plaque Psoriasis

Keywords

plaque psoriasisBTT1023safetypharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Adverse events

    12 weeks

  • Plasma concentrations of BTT1023

    12 weeks

Secondary Outcomes (1)

  • Change in Psoriasis Area and Severity Index (PASI)

    12 weeks

Study Arms (6)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Single 0.3

EXPERIMENTAL
Drug: BTT1023

Repeat 1.0

EXPERIMENTAL
Drug: BTT1023

Repeat 2.0

EXPERIMENTAL
Drug: BTT1023

Repeat 4.0

EXPERIMENTAL
Drug: BTT1023

Repeat 8.0

EXPERIMENTAL
Drug: BTT1023

Interventions

BTT1023DRUG

intravenous, three infusions over three weeks

Repeat 1.0Repeat 2.0Repeat 4.0Repeat 8.0
PlaceboDRUG

intravenous, three infusions over three weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Biotie investigational site

Dresden, Dresden, 01067, Germany

Location

Biotie investigational site

Leipzig, Leipzig, 04103, Germany

Location

Biotie investigational site

Berlin, State of Berlin, 12627, Germany

Location

Biotie investigational site

Berlin, State of Berlin, 14050, Germany

Location

Biotie Investigational Site

Görlitz, 02826, Germany

Location

MeSH Terms

Interventions

timolumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations

DE(5)