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

Biotest

Status and phase

Completed

Phase 2

Conditions

Psoriasis Vulgaris

Treatments

Drug: BT061

Drug: placebo treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01072383

973

Details and patient eligibility

About

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

Full 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).

Enrollment

49 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.