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

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: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: BT061; Drug: placebo treatment

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: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
PGA (Physician's global assessment)	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Itching score	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
DLQI (dermatology life quality index)	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Physical examination	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Differential white blood cell count	weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Cytokine profile	weekly during treatment, then 1 week after last dosing

Collaborators and Investigators

• Sponsor: Biotest
• Investigators: Principal Investigator: Lajos Kemény, M.D., Szegedi Tudományegyetem (Study site)

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 19, 2010
• First Posted (Estimate): February 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 13, 2012
• Last Update Submitted That Met QC Criteria: March 12, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: autoimmune disease; psoriasis vulgaris; chronic plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 973 (2011CB707700)