Psoriasis Vulgaris
Conditions
Keywords
chronic plaque psoriasis, psoriasis vulgaris, autoimmune disease
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).
Interventions
DRUGBT061
administration of BT061 either intravenous or subcutaneous
DRUGplacebo treatment
administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
Sponsors
Biotest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Physical examination | weekly during treatment, then 1 week, 1 month and 3 months after last dosing |
Countries
Czechia, Hungary
Outcome results
None listed