BTT1023 in Psoriasis

Biotie Therapies Corp.26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

BTT1023DRUG

intravenous, three infusions over three weeks

PlaceboDRUG

intravenous, three infusions over three weeks

BTT1023DRUG

Test challenge

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

Biotie investigational site

Dresden, Dresden, Germany

Biotie investigational site

Leipzig, Leipzig, Germany

Biotie investigational site

Berlin, State of Berlin, Germany

Biotie investigational site

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Adverse events

Time frame: 12 weeks

Plasma concentrations of BTT1023

Time frame: 12 weeks

Secondary Outcomes

Change in Psoriasis Area and Severity Index (PASI)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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