Clinical Development
Jasper is evaluating briquilimab in the following company-sponsored clinical trials:
- Chronic Spontaneous Urticaria (ongoing): The Phase 1b/2a BEACON study is evaluating multiple ascending doses of subcutaneous briquilimab as a treatment for adult chronic spontaneous urticaria patients who remain symptomatic after high dose antihistamines and treatment with, or who cannot tolerate, omalizumab. The primary outcome measure for BEACON is incidence and severity of TEAEs and SAEs and secondary outcome measures include UAS7 Score, Urticaria Control Test (UCT) score, and PK and PD measures. The study is being conducted at sites in the US and EU. (NCT06162728)
- Chronic Inducible Urticaria (ongoing): The Phase 1b/2a SPOTLIGHT study is evaluating single ascending doses of subcutaneous briquilimab as a treatment for adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD) despite treatment with H1 antihistamines. The primary outcome measure for SPOTLIGHT is incidence and severity of TEAEs and SAEs and secondary outcome measures include provocation testing of critical temperature threshold for ColdU and critical friction threshold for SD, as well as PK measures. The study is being conducted at sites in the EU. (NCT06353971)
- Asthma (ongoing): Phase 1b/2a ETESIAN challenge study evaluating briquilimab in patients with allergic asthma. Key objectives of the study are to assess safety as well as the early and late asthmatic response and airway hyperresponsiveness following briquilimab administration. The study is being conducted at sites in Canada. (NCT06592768)
- SCID Transplant (ongoing): Phase 1/2 dose-escalation and expansion trial is evaluating briquilimab as a sole conditioning agent to achieve donor stem cell engraftment in patients undergoing hematopoietic stem cell transplantation for SCID. Hematopoietic stem cell transplantation is the only potentially curative treatment for SCID. (NCT02963064)