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

March 12, 2012 updated by: Biotest

A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ostrava, Czech Republic
        • Dermatologic Clinic
      • Prague, Czech Republic
        • Dermatologic Clinic I
      • Prague, Czech Republic
        • Dermatologic Clinic Prague III
      • Prague, Czech Republic
        • Dermatologic Clinic Prague II
      • Ústí nad Labem, Czech Republic
        • Dermatologic Clinic
  • Hungary
      • Budapest, Hungary
        • Dermatologic Clinic
      • Debrecen, Hungary
        • Dermatologic Clinic
      • Miskolc, Hungary
        • Dermatologic Clinic
      • Szeged, Hungary
        • Dermatologic Clinic
      • Szikszo, Hungary
        • Dermatologic Clinic
      • Szolnok, Hungary
        • Dermatologic Clinic
      • Szombathely, Hungary
        • Dermatologic Clinic
      • Veszprém, Hungary
        • Dermatologic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BT061
receiving BT061 (active compound)
Drug: BT061
administration of BT061 either intravenous or subcutaneous
Other Names:
  • SC or IV administration of BT061 or placebo
Placebo Comparator: Placebo
receiving a placebo
Drug: placebo treatment
administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
Other Names:
  • SC or IV administration of BT061 or placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Dose group with the highest number of responders (PASI score improvement)
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing
PGA (Physician's global assessment)
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Itching score
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing
DLQI (dermatology life quality index)
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Physical examination
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Differential white blood cell count
Time Frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Cytokine profile
Time Frame: weekly during treatment, then 1 week after last dosing
weekly during treatment, then 1 week after last dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lajos Kemény, M.D., Szegedi Tudományegyetem (Study site)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 973 (2011CB707700)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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