jRCT2011220047已完成不适用
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- argenx BV
- 入组人数
- 12
- 主要终点
- Proportion of participants who are in complete remission (CR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
入选标准
- •The participant is willing and able to do the following:
- •a. understand the requirements of the study
- •b. provide written informed consent
- •c. comply with the study protocol procedures.
- •The participant is male or female and has reached the age of consent at the time of signing the informed consent form (ICF).
- •Participants have clinical signs of BP.
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:
- •a) Male participants:
- •Must agree to use an acceptable method of contraception from the time that the ICF is signed until the date of their last dose of IMP.
- •b) Female participants:
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered.
- •WOCBP must agree to use at least one of the contraception methods identified in the protocol from the time that the ICF is signed until the date of their last dose of IMP.
排除标准
- •Other forms of pemphigoid or other autoimmune bullous diseases (AIBDs).
- •Received unstable dose of treatments known to cause or exacerbate BP for at least 4 weeks prior to the baseline visit
- •Use of BP treatments other than oral corticosteroids (OCS), topical corticosteroids (TCS), conventional immunosuppressants or dapsone.
- •Known contraindication to OCS therapy
- •Active or chronic infection at screening
- •Positive COVID-19 test result at screening (testing performed if required per local regulations).
- •History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for >=3 years before the first administration of the IMP. Participants with the following cancers can be included at any time, provided they are adequately treated prior to their participation in the study:
- •Basal cell or squamous cell skin cancer
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histological finding of prostate cancer
- •Clinical evidence of other significant serious diseases, have had a recent surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the patient at undue risk
- •Use of an investigational product within 3 months before the first dose of IMP
- •Previously participated in a clinical study with efgartigimod
- •Known hypersensitivity to any of the components of the administered treatments
- •Positive serum test at screening for an active infection:
- •Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse
- •Pregnant or lactating females and those who intend to become pregnant during the study
结局指标
主要结局
Proportion of participants who are in complete remission (CR)
时间窗: week 36
Participants in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for >=8 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
2 期
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.DermatomyositisMyositisAntisynthetase SyndromeActive Idiopathic Inflammatory MyopathyPolymyositisImmune-Mediated Necrotizing MyopathyMyositisAntisynthetase SyndromeDermatomyositisNCT05523167argenx265
进行中（未招募）
3 期
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's SyndromeNCT06684847argenx631
进行中（未招募）
3 期
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaNCT04812925argenx173
Enrolling By Invitation
3 期
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory MyopathyAntisynthetase SyndromeActive Idiopathic Inflammatory MyopathyPolymyositisImmune-Mediated Necrotizing MyopathyMyositisDermatomyositisNCT05979441argenx240
进行中（未招募）
2 期
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)Antibody-mediated RejectionNCT06503731argenx33