EUCTR2021-002818-13-DE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase 2, 12-Week Treatment Study with a 10-Week Follow-up Period to Assess the Efficacy and Safety of Benralizumab (anti-IL5Ra) in Adult Patients with Chronic Prurigo. - BICPIC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Diagnosis: chronic prurigo (defined as ongoing disease)
- •1.Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- •2.Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- •3.Clinical diagnosis of CPG for at least 6 months with:
- •Severe pruritus with WI-NRS rating = 6 (Mean of the worst daily intensity over the previous 3 days at Screening and over the previous week at baseline [minimum of at least 5 days during the week preceding the baseline visit]).
- •Pruriginous nodular, papular, plaque and/or umbilicated lesions on upper limbs, trunk, and/or lower limbs
- •At least 20 CPG lesions on the entire body with a bilateral distribution
- •4.Willing and able to complete a daily symptom Diary for the duration of the study and adhere to the study visit schedules.
- •5.Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control
- •6.Negative COVID-19 test
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.Chronic pruritus resulting from another active condition other than CPG
- •2.Unilateral lesions of prurigo (e.g., only one arm affected)
- •3.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •4.Patients who previously received benralizumab
- •5.Patients with hypersensitivity to any of the excipients of the IMP or history of anaphylaxis to any biologic therapy or vaccine.
- •6.Any disorder that is not stable in the opinion of the Investigator and could: (a) Affect the safety of the participant throughout the study, (b) Influence the findings of the studies or their interpretations, (c) Impede the participant’s ability to complete the entire duration of study.
- •7.Inability to comply with study and follow-up procedures.
- •8.Current malignancy, or history of malignancy within the last 5 years
- •9.Current active liver disease
- •10.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
- •11.Subjects who live in detention on court order or on regulatory action as per local and national law (see §40a subsection 2 Arzneimittelgesetz)
- •12.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •13.Patients with active COVID-19 infection. Patients with symptoms consistent with COVID-19 infection should be tested prior to enrollment.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Alcoholic hepatitisEUCTR2020-004534-38-DEDURECT Corporation300
进行中（未招募）
不适用
A Clinical Trial Investigating OSI-906 in Patients with Adrenocortical CarcinomaAdrenocortical CarcinomaMedDRA version: 14.1Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-012820-97-DEAstellas Pharma Global Development, Inc.135
招募中
3 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast CancerBreast carcinoma10006291Breast cancerNL-OMON51870Merck Sharp & Dohme (MSD)24
进行中（未招募）
不适用
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseSecondary hyperparathyroidism in subjects with chronic kidney diseaseMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disordersEUCTR2012-002805-23-ATKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500
进行中（未招募）
1 期
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282