BTT1023 in Psoriasis

Biotie Therapies

Status and phase: Completed; Phase 1

Conditions: Plaque Psoriasis

Treatments: Drug: BTT1023; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871598

BTT12-CD016

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Single 0.3

Experimental group

Treatment:

Drug: BTT1023

Drug: BTT1023

Repeat 1.0

Experimental group

Treatment:

Drug: BTT1023

Drug: BTT1023

Repeat 2.0

Experimental group

Treatment:

Drug: BTT1023

Drug: BTT1023

Repeat 4.0

Experimental group

Treatment:

Drug: BTT1023

Drug: BTT1023

Repeat 8.0

Experimental group

Treatment:

Drug: BTT1023

Drug: BTT1023