Back to results

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

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BT061

placebo treatment

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring chronic plaque psoriasis, psoriasis vulgaris, autoimmune disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BT061

Placebo

Arm Description

receiving BT061 (active compound)

receiving a placebo

Outcomes

Primary Outcome Measures

Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,

Secondary Outcome Measures

Dose group with the highest number of responders (PASI score improvement)

PGA (Physician's global assessment)

Itching score

DLQI (dermatology life quality index)

Physical examination

Differential white blood cell count

Cytokine profile

Full Information

NCT ID

NCT01072383

First Posted

February 18, 2010

Last Updated

March 12, 2012

Sponsor

Biotest

1. Study Identification

Unique Protocol Identification Number

NCT01072383

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotest

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

Keywords

chronic plaque psoriasis, psoriasis vulgaris, autoimmune disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BT061

Arm Type

Experimental

Arm Description

receiving BT061 (active compound)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

receiving a placebo

Intervention Type

Drug

Intervention Name(s)

BT061

Other Intervention Name(s)

SC or IV administration of BT061 or placebo

Intervention Description

administration of BT061 either intravenous or subcutaneous

Intervention Type

Drug

Intervention Name(s)

placebo treatment

Other Intervention Name(s)

SC or IV administration of BT061 or placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,

Time Frame