Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

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

Study Snapshot

  • Program: Briquilimab
  • Study ID(s): NCT06162728
  • Phase: Phase 1, Phase 2
  • Indication: Chronic Spontaneous Urticaria
  • Status: Active Not Recruiting
  • Sponsor: Jasper Therapeutics, Inc.

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: SEQUENTIAL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 88 (ACTUAL)

Population

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

Operational design summary

  • Arms represented in current CT.gov export: 2
  • Active dose regimens represented in current local source layer: NR
  • Total study enrollment in CT.gov: 88 (ACTUAL)
  • Per-arm sample size summary: 88 total across 2 listed arms; exact arm-specific counts are not explicitly stated in the current local source text.
  • Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
Briquilimab EXPERIMENTAL NR NR NR 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. NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Placebo PLACEBO_COMPARATOR NR NR NR Placebo Comparator NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer

Endpoints

  • Primary outcomes:
  • Evaluate the safety and tolerability of briquilimab (time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 48 weeks))

Clinical Pharmacology Findings

  • PK: ClinicalTrials.gov summary text indicates pharmacokinetics were part of the study objectives or assessments.
  • PD: ClinicalTrials.gov summary text indicates pharmacodynamics were part of the study objectives or assessments.
  • 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/NCT06162728
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT06162728.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):
  • NCT06162728
  • ../raw/clinicaltrials/markdown/NCT06162728.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.