drugset / Trial / NCT06353971
A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines
NaSequentialOpen-labelTreatment
Summary
This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore three ascending dose levels which will be tested in three sequential cohorts.
Timeline
- Start
- 2024-03-18
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Briquilimab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Briquilimab | Monoclonal antibody | 120 mg | Subcutaneous |
| Subject | Briquilimab | Monoclonal antibody | 180 mg | Subcutaneous |