This Phase II clinical study is to test safety and efficacy of BT061 against psoriasis given as repeated doses.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
administration of BT061 either intravenous or subcutaneous
administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
Dermatologic Clinic
Ostrava, Czechia
Dermatologic Clinic I
Prague, Czechia
Dermatologic Clinic Prague III
Prague, Czechia
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Improvement in PASI score (Psoriasis Area and Severity Index) , as compared to PASI at baseline visit,
Time frame: 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)
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
PGA (Physician's global assessment)
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Itching score
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
DLQI (dermatology life quality index)
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Physical examination
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Differential white blood cell count
Time frame: weekly during treatment, then 1 week, 1 month and 3 months after last dosing
Cytokine profile
Time frame: weekly during treatment, then 1 week after last dosing
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Prague, Czechia
Dermatologic Clinic
Ústí nad Labem, Czechia
Dermatologic Clinic
Budapest, Hungary
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Debrecen, Hungary
Dermatologic Clinic
Miskolc, Hungary
Dermatologic Clinic
Szeged, Hungary
Dermatologic Clinic
Szikszó, Hungary
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