EUCTR2016-000613-79-CZ进行中（未招募）1 期
Efficacy, Safety, and Immunogenicity of BI 695501 versus Humira® in Patients with Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Males and females aged = 18 to < 80 years who have a diagnosis of moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study drug, and which has been stable for the last 2 months with no changes in morphology or significant flares at both Screening and Baseline (Randomization):
- •a. involved BSA = 10% and
- •b. PASI score = 12 and
- •c. sPGA score of = 3.
- •2. Participants of reproductive potential (childbearing potential) willing and able to use highly effective methods of birth control.
- •3. Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial.
- •4. Patients who are candidates for systemic therapy.
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Active inflammatory diseases other than psoriasis that might confound trial evaluations.
- •2. Previous treatment with more than 1 biological agent, or adalimumab or adalimumab Biosimilar. No prior biologic exposure within last 6 months of screening will be permitted.
- •3. significant disease other than psoriasis and/or a significant uncontrolled Disease.
- •4. Major surgery performed within 12 weeks prior to randomization or planned within 6 months after screening.
- •5. documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •6. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- •7. Currently enrolled in another investigational device or drug study.
- •8. Chronic alcohol or drug abuse.
- •9. Women who are pregnant, nursing, or who plan to become pregnant during the study or within 6 months following completion or discontinuation from trial.
- •10. Forms of psoriasis other than chronic plaque psoriasis. Drug-induced psoriasis.
- •11. Primary or secondary immunodeficiency, including known history of HIV infection or a positive HIV test at screening.
- •12. Known chronic or relevant acute tuberculosis.
- •13. Known clinically significant coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure or interstitial lung disease observed on chest X-ray.
- •14. History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a previously used biological drug or its excipients.
- •15. Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •16. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit; patients who are expecting to receive any live/attenuated virus or bacterial vaccinations during the trial or up to 3 months after the last dose of trial drug.
- •17. Any treatment that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
- •18. Known active infection of any kind (excluding fungal infections of nail beds), any major episode of infection requiring hospitalization or treatment with intravenous (i.v.) anti-infectives within 4 weeks of the
- •Screening or completion of oral anti-infectives within 2 weeks of the Screening Visit.
- •19. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) at Screening.
- •20. Hemoglobin < 8.0 g/dL at Screening.
- •21. Platelets < 100,000/µL at Screening.
- •22. Leukocyte count < 4000/µL at Screening.
- •23. Creatinine clearance < 60 mL/min/1.73 m2 at Screening.
- •24. Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins, or natural rubber and latex, including serious allergic reactions.
研究者
相似试验
进行中（未招募）
1 期
Efficacy, Safety, and Immunogenicity of BI 695501 versus Humira® in Patients with Moderate to Severe Chronic Plaque PsoriasisModerate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-000613-79-PLBoehringer Ingelheim International GmbH300
进行中（未招募）
1 期
Efficacy, Safety, and Immunogenicity of BI 695501 versus Humira® in Patients with Moderate to Severe Chronic Plaque PsoriasisModerate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-000613-79-DEBoehringer Ingelheim International GmbH300
进行中（未招募）
1 期
BI695501 compared to adalimumab in patients with active rheumatoid arthritisRheumatoid arthritisEUCTR2012-002945-40-ESBoehringer Ingelheim International GmbH600
进行中（未招募）
1 期
BI695501 compared to adalimumab in patients with active rheumatoid arthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2012-002945-40-HUBoehringer Ingelheim International GmbH650
进行中（未招募）
1 期
BI695501 compared to adalimumab in patients with active rheumatoid arthritisMedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2012-002945-40-BGBoehringer Ingelheim International GmbH650