EUCTR2008-007458-37-HU进行中（未招募）1 期
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 (mab) BT061 administered subcutaneously or intravenously as 8 repeated doses to patients with moderate to severe chronic plaque psoriasis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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