patients with moderate to severe chronic plaque psoriasis MedDRA version: 12.0 Level: LLT Classification code 10037153 Term: Psoriasis MedDRA version: 12.0 Level: PT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: BT061
Product Code: BT061
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal antibody
Current Sponsor code: BT061
Concentration unit: mg/m
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients must meet all the following criteria: 1. Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed = 12 months prior to Screening. 2. BSA involvement > 10% for more than 6 months. 3. PASI = 10. 4. Age = 18 to = 75 years. 5. Body mass index (BMI) of 18–30 kg/m2 with a body weight between 50 and 130 kg. 6. Patient on any medication prescribed for another indication must be at stable dose for at least 14 days prior to the administration of BT061 or placebo. 7. Cluster of differentiation 4 (CD4) cell count at Screening Visit is = 75% the lower limit of normal. 8. B cell count at Screening Visit is = 75% the lower limit of normal. 9. Written informed consent (signed and dated by patient). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Erythrodermic, guttate or palmar pustular psoriasis a. Mixed forms of plaque psoriasis (psoriasis vulgaris) with palmar pustular psoriasis, such as psoriasis vulgaris cum pustulatione, are allowed as long as psoriasis vulgaris is the predominant form. b. Patients with a history of psoriasis guttata are admitted as long as psoriasis vulgaris is the predominant diagnosis at the time of inclusion c. Patients with ongoing psoriasis guttata cannot be enrolled. 2. 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. Compounds where 5 half-lives exceed 30 days have therefore to be washed out for at least 5 half-lives. 3. Treatment with systemic retinoids, corticosteroids and immunosuppressants within 4 weeks prior to the administration of BT061 or placebo. 4. Any other systemic psoriasis relevant treatment (hydroxychloroquine, chloroquine, lithium) within 4 weeks prior to the administration of BT061 or placebo. 5. High potency topical treatments (corticosteroids, keratolytics, coal tar) within 2 weeks prior to the administration of BT061 or placebo. 6. Psoralen and Ultraviolet A (PUVA) therapy within 4 weeks prior to the administration of BT061 or placebo. 7. Ultraviolet B (UVB) therapy within 2 weeks prior to the administration of BT061 or placebo. 8. Recent holiday (within the last 2 weeks) with greater than usual sun exposure or plans to go on such a holiday before Final Follow-up visit. 9. Treatment with leflunomide within 8 weeks prior to the administration of BT061 or placebo (except specific wash out procedure, i. e. 11 days with colestyramine or activated charcoal plus 30 days wash-out). 10. Clinically relevant abnormalities regarding haematocrit, haemoglobin or platelets, serum concentration of creatinine or bilirubin, or in complete cell count and differential cell count. 11. Kidney insufficiency as defined by creatinine clearance: < 60 ml/min (Cockcroft Gault equation). 12. Alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) = 3 times the upper limit of normal. 13. History of clinically significant major disease i.e., severe heart/ lung diseases New York Heart Association (NYHA) ? 3 (class III: patients with marked limitation of activity; comfortable only at rest). 14. Acute or clinically relevant abnormalities in electrocardiogram (ECG). 15. History of malignancy during 5 years prior to Screening visit (except squamous or basal cell carcinoma of the skin). 16. Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo. 17. Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis). 18. Presence or history of severe uncontrolled allergies or anaphylactic reactions. 19. Presence of severe uncontrolled hypertension or hypotension. 20. Presence of acute uncontrolled hypothyroidism or hyperthyroidism. 21. Positive diagnosis of latent or active tuberculosis. 22. Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at Screening visit. 23. Positive cytomegalovirus (CMV) viral load in serum at Screening visit. 24. Positive Epstein-Barr Virus (EBV) immunoglobulin class M (IgM) titre or EBV viraemia at Screening visit. Patients with a positive polymerase chain reaction (PCR) result in lymphocyte de
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this clinical phase IIa study is to demonstrate efficacy and safety of multiple doses of BT061. ;Secondary Objective: Secondary objectives are to identify the most effective subcutaneous dose strength in comparison to placebo and to compare the efficacy of subcutaneous versus intravenous administration. ;Primary end point(s): The primary endpoint is the response rate defined as the proportion of patients experiencing a 75% reduction in psoriasis using the PASI 75 at the end-of-treatment visit (Visit 18, Week 9). Multiple doses of BT061 or placebo will be administered weekly by intravenous infusion (Cohorts 1 and 2; 0.5 and 2.0 mg BT061, respectively) or subcutaneous administration (Cohorts 3, 4, 5, and 6; 25–100 mg BT061). Patients will be screened 4 weeks prior to commencement of the treatment period and will have a pre-treatment visit at Day -5 to -1. The treatment is scheduled for 8 weekly administrations over a period of 8 weeks, followed by an end of treatment visit 1 week after the last treatment (Week 9) and a subsequent follow-up period of 11 weeks (total follow-up: 12 weeks). In total, 48 patients are planned to be enrolled into 6 cohorts with 8 patients per cohort: 6 patients receiving the active IMP, BT061, and 2 patients receiving placebo (buffer of BT061), resulting in a randomisation ratio of 3:1 active IMP versus placebo. Patients withdrawn from the study before administration of the last planned dose will not be replaced. The patients will be treated as outpatients in clinics in 10–15 study sites in 2 countries. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed