EUCTR2020-000585-41-DE进行中（未招募）1 期
Effects of tregalizumab on allergen-induced airway responses and airway inflammation in asthmatic patients - Tregulaire
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •1.Willing and able to give written informed consent
- •2.Male or female subject aged 18 to 65 years (both inclusive).
- •3.Established diagnosis of mild controlled allergic asthma (GINA 2019) and history of allergic bronchial asthma for at least 1 year.
- •4.Body mass index (BMI) of 18.0 to 30.0 (both inclusive).
- •5.Non-smoker (all substances).
- •6.Specific IgE to HDM (Dermatophagoides farinae) = class 2 in radioallergosorbent test (RAST).
- •7.BHR (i.e., a decrease in FEV1 of at least 20%) measured by methacholine challenge.
- •8.FEV1 = 75% of predicted value (according to height, weight and sex).
- •9.Subject must demonstrate a significant EAR and LAR without rescue medication use within the first 7 hours after BAP. EAR is defined as a decrease in FEV1 of = 20% within 0 to 3 hours after allergen challenge; LAR is defined as a decrease in FEV1 of = 15% within 4 to 7 hours after BAP.
- •10.No clinically relevant abnormalities in 12-lead ECG at screening.
- •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 42
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Severe, unstable bronchial asthma.
- •2.Exacerbation of asthma = 4 weeks prior to screening.
- •3.Treatment with parenteral and oral corticosteroids 6 weeks prior to screening and during the study.
- •4.Treatment with inhaled corticosteroids, methylxanthines (e.g., theophyllin), anticholinergics (e.g., ipratropium bromide), leukotriene modifiers (e.g., montelukast), tiotropium bromide, cromolyn or nedocromil within 2 weeks prior to screening and during the study.
- •5.Current treatment with any immunosuppressants (e.g., monoclonal antibodies, methotrexate, cyclosporin).
- •6.Specific immunotherapy (SCIT) to mite within 3 years prior to screening.
- •7.Serious adverse drug reaction to previous biological treatment.
- •8.Previous therapy with a monoclonal antibody (mAb) targeting CD4, including tregalizumab.
- •9.Known hypersensitivity to any constituents of tregalizumab, and/or other mAbs, that, in the opinion of the investigator or Medical Monitor, contraindicates participation.
- •10.Previous inclusion in this study.
- •11.Serum transaminases, alanine transaminase (ALAT) and/or aspartate transaminase (ASAT) > 2.5-fold upper level of normal (ULN) at screening.
- •12.Bilirubin > 34.2 µmol/L at screening.
- •13.Alkaline phosphatase (AP) > 2-fold ULN at screening.
- •14.Urea nitrogen > 1.5-fold ULN at screening.
- •15.Kidney insufficiency as defined by creatinine level > 133 µmol/L at screening.
- •16.History of severe allergic or anaphylactic reaction to proteins of human origin (e.g. vaccination reaction, biological therapy).
- •17.Presence or history of malignancy within the previous 5 years (except completely resected squamous or basal cell carcinoma of the skin).
- •18.Presence or history of clinically significant major disease (e.g., severe heart/lung disease New York Heart Association [NYHA] Class = 3, autoimmune disease [apart from rheumatoid arthritis], acute uncontrolled hyper- or hypo-thyroidism, severe uncontrolled hypo or hypertension).
- •19.Serious local (e.g., abscess) or systemic (e.g., pneumonia, septicemia) infection or recurrent chronic infections within 6 weeks prior to screening visit or during the screening period.
- •20.Any infection requiring antibiotic therapy by any route of administration within 4 weeks prior to screening.
- •21.Vaccination with live, live attenuated, and/or killed vaccines in the 12 weeks prior to the first administration of the study drug and during the study.
- •22.Positive diagnosis for acute or chronic infections (e.g. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at screening or history of previous chronic infection.
- •23.Acute or clinically symptomatic Epstein-Barr Virus (EBV) (infectious mononucleosis) or Cytomegalovirus (CMV) infection.
- •24.Presence or history of latent or active tuberculosis.
- •25.Known immune deficiency.
- •26.Presence or history of lymphoproliferative disease, including lymphoma and lymphadenopathy.
- •27.Presence or history of clinically significant drug or alcohol abuse.
- •28.Employee at study site or any institution involved in this study (including the sponsor), or spouse/partner or relative of an investigator.
- •29.Pregnant or nursing woman or woman considering to become pregnant during the study or in the 3 months after the last administration of study drug.
- •30.Woman of childbearing potential (unless surgically sterile or post-menopausal > 52 weeks) who is not using two (2) independent effective contraceptive methods (e.g., oral or injectable contraceptives, intra-uterine devices, double barrie
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