相关临床试验
62
29 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
28
45.2%
已完成
19
30.6%
尚未招募
1
1.6%
招募中
12
19.4%
Unknown
2
3.2%
暂无批准数据
- Sobi announced positive topline results from the Phase 2a EMBRACE study evaluating Gamifant (emapalumab) for interferon-gamma-driven sepsis, showing proof-of-concept with improvements in organ dysfunction and survival. - The trial targeted a newly identified sepsis endotype affecting approximately 20% of sepsis patients, characterized by elevated CXCL9 levels and poor clinical outcomes with 28-day mortality rates of 40-43%. - Based on these encouraging results, Sobi and the Hellenic Institute for the Study of Sepsis will advance emapalumab development and discuss next clinical steps with regulatory authorities. - The randomized controlled trial enrolled 75 patients across 24 sites in Greece, comparing two doses of Gamifant plus standard care against placebo plus standard care.
- A multinational randomized clinical trial demonstrates that precision immunotherapy tailored to patients' immune profiles significantly improved organ dysfunction in sepsis patients. - The ImmunoSep study enrolled 276 patients across six countries, stratifying them based on immune status into macrophage activation-like syndrome or sepsis-induced immunoparalysis groups. - Patients receiving targeted immunotherapy showed 35.1% improvement in organ dysfunction compared to 17.9% in placebo group, though 28-day mortality rates remained unchanged. - The precision approach represents a critical advancement over previous "one-size-fits-all" immunotherapy strategies that have repeatedly failed in sepsis treatment.
- Sobi has initiated the EMBRACE Phase 2a clinical trial to evaluate Gamifant (emapalumab) for treating interferon-gamma-driven sepsis (IDS), a newly identified endotype affecting approximately 20% of sepsis patients with 40-43% mortality rate. - The double-blind, randomized controlled trial will enroll 75 patients across 24 sites in Greece, targeting patients with the IDS endotype who do not exhibit sepsis-induced immunoparalysis. - The study represents a precision medicine approach to sepsis treatment, with primary endpoints measuring improvement in organ function and secondary endpoints including 28-day mortality and changes in inflammatory biomarkers.
