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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT061 | Experimental | receiving BT061 (active compound) |
|
| Placebo | Placebo Comparator | receiving a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BT061 | Drug | administration of BT061 either intravenous or subcutaneous |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lajos Kemény, M.D. | Szegedi Tudományegyetem (Study site) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologic Clinic | Ostrava | Czechia | ||||
| Dermatologic Clinic I |
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| placebo treatment | Drug | administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous |
|
|
| 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 |
| Prague |
| Czechia |
| Dermatologic Clinic Prague III | Prague | Czechia |
| Dermatologic Clinic Prague II | Prague | Czechia |
| Dermatologic Clinic | Ústí nad Labem | Czechia |
| Dermatologic Clinic | Budapest | Hungary |
| Dermatologic Clinic | Debrecen | Hungary |
| Dermatologic Clinic | Miskolc | Hungary |
| Dermatologic Clinic | Szeged | Hungary |
| Dermatologic Clinic | Szikszó | Hungary |
| Dermatologic Clinic | Szolnok | Hungary |
| Dermatologic Clinic | Szombathely | Hungary |
| Dermatologic Clinic | Veszprém | Hungary |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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