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

Study Snapshot

• Program: Briquilimab
• Study ID(s): NCT06353971
• Phase: Phase 1, Phase 2
• Indication: Chronic Inducible Urticaria
• Status: Terminated
• Sponsor: Jasper Therapeutics, Inc.

Design

• Study type: INTERVENTIONAL
• Randomization / allocation: NA
• Intervention model: SEQUENTIAL
• Masking: NONE
• Primary purpose: TREATMENT
• Enrollment: 27 (ACTUAL)

Population

• Conditions: Chronic Inducible Urticaria
• Sex: ALL
• Age range: 18 Years to None
• Healthy volunteers: False
• 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.

Operational design summary

• Arms represented in current CT.gov export: 1
• Active dose regimens represented in current local source layer: 1
• Total study enrollment in CT.gov: 27 (ACTUAL)
• Per-arm sample size summary: Briquilimab n=27
• Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Endpoints

• Primary outcomes:
• 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. (time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (Week 36))

Clinical Pharmacology Findings

• PK: Not clearly summarized in the currently linked local source snippets.
• PD: Not clearly summarized in the currently linked local source snippets.
• Linked manuscripts: No trial-level primary publication is explicitly linked in the current registry.

Safety Findings

• Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.

Linked Evidence

• CT.gov page: https://clinicaltrials.gov/study/NCT06353971
• Local CT.gov cache: raw/clinicaltrials/markdown/NCT06353971.md

Interpretation

• Verified facts: this page reflects the current local registry and CT.gov inventory export without inferring unsupported arm sizes or endpoint results.
• Interpretation: this trial is currently represented mainly by CT.gov and any linked sponsor-source artifacts; manual enrichment is still needed for a richer narrative page.
• Open questions:
• Some studies still lack exact arm-specific N in the current promoted evidence layer even when allocation schema or total enrollment is visible.
• No explicit trial-level primary manuscript is currently linked in the registry.
• No sponsor artifact is explicitly linked to this trial by identifier in the current registry.

Provenance

• Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
• Primary source(s):
• NCT06353971
• ../raw/clinicaltrials/markdown/NCT06353971.md
• ../inventories/source_registry.json
• Supporting source(s):
• ../inventories/ctgov_priority_trials.json
• Last verified: 2026-04-08
• Verification status: Partial

Change Log

• 2026-04-08: Generated or refreshed this study page from the v2 source registry and CT.gov inventory.