Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)
brief summary
This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled. The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment with H1 antihistamines and omalizumab. Additionally, pharmacokinetic (PK) properties of briquilimab, and other pharmacodynamic (PD) parameters (such as effects on mast cells (MC), serum tryptase levels, and on allergic skin reactivity) will be investigated.
official title
A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines and/or Omalizumab, or Who Cannot Tolerate Omalizumab