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

Study Overview
=================
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).

Official Title
-----------------
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

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: BT061
* Drug: placebo treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT061<br>receiving BT061 (active compound) | Drug: BT061<br>* administration of BT061 either intravenous or subcutaneous<br>* Other names: SC or IV administration of BT061 or placebo;|
| Placebo Comparator: Placebo<br>receiving a placebo | Drug: placebo treatment<br>* administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous<br>* Other names: SC or IV administration of BT061 or placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic plaque psoriasis, psoriasis vulgaris, autoimmune disease