2024-519469-23-00招募中2 期
A Long-Term Extension Study to Evaluate Safety and Efficacy of Verekitug (UPB-101) in Adult Participants with Severe Asthma who Completed the VALIANT Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 123
- 试验地点
- 33
- 主要终点
- To check if verekitug is safe, participants will be monitored for any side effects from the time the participant agrees to join the study until the participant completes the study. Participants will also have physical examinations, clinical laboratory assessments, vital sign measurements, and ECGs from the first LTE study visit, or last VALIANT study visit, until the participant completes the LTE study.
研究概览
简要总结
To check if long-term treatment with verekitug is safe and tolerable for adults with severe asthma.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-Up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Completion of the VALIANT study per protocol. Participants must have not met VALIANT discontinuation criteria and have attended the VALIANT EOS visit.
- •Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study.
- •Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Abnormal medical history, physical finding, or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant’s safety.
- •Any clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant’s safety.
- •Participant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction).
- •Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
- •Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
- •Participant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the Investigator or has any disorder that may compromise their ability to give informed consent.
结局指标
主要结局
To check if verekitug is safe, participants will be monitored for any side effects from the time the participant agrees to join the study until the participant completes the study. Participants will also have physical examinations, clinical laboratory assessments, vital sign measurements, and ECGs from the first LTE study visit, or last VALIANT study visit, until the participant completes the LTE study.
To check if verekitug is safe, participants will be monitored for any side effects from the time the participant agrees to join the study until the participant completes the study. Participants will also have physical examinations, clinical laboratory assessments, vital sign measurements, and ECGs from the first LTE study visit, or last VALIANT study visit, until the participant completes the LTE study.
次要结局
- The change in the following from the start of the LTE study up to Week 60 will be recorded: how much air the participant can forcefully exhale in 1 second; how much nitric oxide is in the exhaled air as a measure of airway inflammation; and how well the participant’s asthma is being managed via a scored questionnaire about asthma symptoms and treatment.
- The amount of verekitug in the blood will be measured at each visit to see how the body processes verekitug. The blood will also be checked for antibodies against verekitug during the LTE study (from the first to last visit) to check for an immune response.
- To check the effects of verekitug, the number of severe asthma flare-ups or attacks that require treatment with steroids over 60 weeks of treatment will be recorded.
研究者
James Lee
Scientific
Upstream Bio Inc.
研究点 (33)
Loading locations...
相似试验
招募中
3 期
Vedolizumab Subcutaneous Long-term Open-label Extension Study in Pediatric Subjects2023-508804-39-00Takeda Development Center Americas Inc.32
Enrolling By Invitation
不适用
"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDNHypertensionNCT07273877Shanghai Golden Leaf MedTec Co. Ltd1,000
进行中（未招募）
2 期
在哮喘成人参与者中评价 lunsekimig（SAR443765）的长期安全性和疗效CTR2024380886
招募中
2 期
A Study to Assess the Long-Term Efficacy and Safety of Afimkibart (RO7790121) in Patients with Atopic Dermatitis who participated in previous Afimkibart Clinical TrialsAtopic Dermatitis2025-520771-59-00F. Hoffmann-La Roche AG49
招募中
3 期
An Open-Label Extension Study of Fazirsiran2023-503497-21-00Takeda Development Center Americas Inc.18