Safety and Efficacy of Multiple Doses of BT061 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-08-31

Brief Summary

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This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.

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Detailed Description

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Patients are enrolled into escalating dose levels. Improvement of PASI, physician's global assessment and itching score is evaluated after administration of BT061 or placebo. Safety data are assessed by an independent data and safety monitoring board (DSMB).

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BT061

receiving BT061 (active compound)

Group Type EXPERIMENTAL

BT061

Intervention Type DRUG

administration of BT061 either intravenous or subcutaneous

Placebo

receiving a placebo

Group Type PLACEBO_COMPARATOR

placebo treatment

Intervention Type DRUG

administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous

Interventions

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BT061

administration of BT061 either intravenous or subcutaneous

Intervention Type DRUG

placebo treatment

administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous

Intervention Type DRUG

Other Intervention Names

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SC or IV administration of BT061 or placebo SC or IV administration of BT061 or placebo

Eligibility Criteria

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Inclusion Criteria

* Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed ≥ 12 months prior to Screening.
* BSA (Body surface area) involvement \> 10% for more than 6 months.
* PASI ≥10.
* Age ≥ 18 to ≤ 75 years.
* Body mass index (BMI) of 18-30 kg/m2 with a body weight between 50 and 130 kg.

Exclusion Criteria

* Erythrodermic, guttate or palmar pustular psoriasis (mixed forms may be admissible if chronic plaque psoriasis clearly remains the predominant diagnosis
* Treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of BT061/placebo.
* Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo.
* Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis).
* Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus \[HCV\], Hepatitis B Virus \[HBV\], Human Immunodeficiency Virus \[HIV\]) at Screening visit.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No