Open-Label Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Chronic Urticaria

Jasper Therapeutics, Inc.37 个研究点分布在 2 个国家目标入组 67 人2024年11月26日

适应症Urticaria Chronic

干预措施Briquilimab

概览

阶段: 2 期
干预措施: Briquilimab
疾病 / 适应症: Urticaria Chronic
发起方: Jasper Therapeutics, Inc.
入组人数: 67
试验地点: 37
主要终点: To evaluate the safety and tolerability of briquilimab
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.

详细描述

This is a Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial, specifically the BEACON (JSP-CP-011) and SPOTLIGHT (JSP CP-010) trials (referred to as "parent studies") and future CU trials sponsored by Jasper Therapeutics.

注册库

clinicaltrials.gov

开始日期

2024年11月26日

结束日期

2026年9月30日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Jasper Therapeutics, Inc.

责任方

Sponsor

入排标准

入选标准

•Provides informed written consent.
•Previously participated in and completed an eligible Jasper-sponsored clinical trial (in the last 4 months) without any investigational product (IP)-related anaphylactic event
•Disease specific eligibility:
•Participants with CSU have a UAS7 of 16 or greater following the completion of at least 8 weeks of safety follow up in the parent study OR anyone who completed their parent study regardless of UAS7 score.
•Participants with CIndU (cold contact urticaria \[ColdU\] or symptomatic dermographism) have a UCT of 12 or less following the completion of at least 8 weeks of safety follow up in the parent study OR anyone who completed their parent study regardless of UCT score.
•The laboratory parameters to be within the acceptable range as follows:
•Hemoglobin: ≥ 10 g/dL
•Platelets: ≥ 100,000/mm3
•Neutrophils: ≥ 1,500/mm3
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 × the upper limit of normal (ULN)

排除标准

•Participated in or currently participating in an interventional clinical trial investigating an experimental therapy following cessation of participation in a Jasper-sponsored CU trial.
•Other active diseases with possible symptoms of urticaria, wheals or angioedema, including urticarial vasculitis, erythema multiforme, systemic or cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
•Women who are pregnant or nursing or intend to become pregnant during the course of the trial
•Any known contraindications or hypersensitivity to any component of briquilimab, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies) or antihistamines or leukotrienes. Those who have previously experienced an IP-related anaphylactic event, IP-related SAE, or IP-related AE that led to treatment discontinuation in a prior Jasper-sponsored urticaria clinical trial, which in the opinion of the Investigator or medical monitor, may indicate that continued treatment could present an unreasonable risk to the participant are also excluded.
•Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or briquilimab administration or could interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the participant inappropriate for entry into the trial.