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Briquilimab · SPOTLIGHT

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

Ensayo de Jasper Therapeutics, Inc. en Chronic Inducible Urticaria (del registro, en inglés).

Fase

Fase 1/2

Estado

Interrumpido

Participantes

27

previstos

Centros

5

Fin del objetivo primario

jul 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2024.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Enrollment was completed and primary efficacy endpoint was completed. Study was terminated before safety follow up was completed due to changes in company priorities and not related to safety concerns».

Qué mide

Incidence and severity of treatment emergent AEs/SAEs [safety and tolerability] of a single dose of briquilimab in patients with ColdU or SD who remain symptomatic despite the use of H1 antihistamines. (From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de JSPR

Todos los de JSPR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06353971), actualizada en oct 2025.