NCT06162728

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Jasper Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	Briquilimab	Subcutaneous Administration
OTHER	Placebo	Placebo Comparator

Timeline

• Start date: 2023-11-29
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-12-08
• Last updated: 2026-01-22

Locations

23 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study