Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Study Snapshot

  • Program: Barzolvolimab
  • Study ID(s): NCT07266402
  • Phase: Phase 3
  • Indication: Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
  • Status: Recruiting
  • Sponsor: Celldex Therapeutics

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 240 (ESTIMATED)

Population

  • Conditions: Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
  • Sex: ALL
  • Age range: 18 Years to None
  • Healthy volunteers: False
  • Summary: The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.

Operational design summary

  • Arms represented in current CT.gov export: 4
  • Active dose regimens represented in current local source layer: 1
  • Total study enrollment in CT.gov: 240 (ESTIMATED)
  • Per-arm sample size summary: 240 total across 4 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
barzolvolimab 450mg loading dose followed by 150mg in patients with Cold Induced Urticaria EXPERIMENTAL 450mg -> 150mg Q4W Subcutaneous barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks 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 comparator in patients with Cold Induced Urticaria PLACEBO_COMPARATOR NR Q4W Subcutaneous Placebo injection subcutaneously every 4 weeks for 24 weeks NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
barzolvolimab 450mg loading dose followed by 150mg in patients with Symptomatic Dermographism EXPERIMENTAL 450mg -> 150mg Q4W Subcutaneous barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks 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 comparator in patients with Symptomatic Dermographism PLACEBO_COMPARATOR NR Q4W Subcutaneous Placebo injection subcutaneously every 4 weeks for 24 weeks 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:
  • Complete response to provocation testing at Week 12 (time frame: From Day 1 (first dose) to Week 12)

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/NCT07266402
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT07266402.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):
  • NCT07266402
  • ../raw/clinicaltrials/markdown/NCT07266402.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.