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

Psoriasis Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072383
• Other study ID #: 973
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2010
• Last updated: March 12, 2012
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Biotest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• BT061
administration of BT061 either intravenous or subcutaneous
• placebo treatment
administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous

Locations

Country	Name	City	State
Czech Republic	Dermatologic Clinic	Ostrava
Czech Republic	Dermatologic Clinic I	Prague
Czech Republic	Dermatologic Clinic Prague II	Prague
Czech Republic	Dermatologic Clinic Prague III	Prague
Czech Republic	Dermatologic Clinic	Ústí nad Labem
Hungary	Dermatologic Clinic	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

Sponsors (1)

Lead Sponsor	Collaborator
Biotest

Countries where clinical trial is conducted

Czech Republic,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	No
Secondary	Dose group with the highest number of responders (PASI score improvement)		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	No
Secondary	PGA (Physician's global assessment)		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	No
Secondary	Itching score		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	No
Secondary	DLQI (dermatology life quality index)		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	No
Secondary	Physical examination		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	No
Secondary	Differential white blood cell count		weekly during treatment, then 1 week, 1 month and 3 months after last dosing	Yes
Secondary	Cytokine profile		weekly during treatment, then 1 week after last dosing	Yes