Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Study Snapshot

  • Program: Barzolvolimab
  • Study ID(s): NCT06445023
  • Phase: Phase 3
  • Indication: Chronic Spontaneous Urticaria
  • Status: Active Not Recruiting
  • Sponsor: Celldex Therapeutics

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 963 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to None
  • Healthy volunteers: False
  • Summary: The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.

Operational design summary

  • Arms represented in current CT.gov export: 4
  • Active dose regimens represented in current local source layer: 4
  • Total study enrollment in CT.gov: 963 (ACTUAL)
  • Per-arm sample size summary: 963 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 150 mg EXPERIMENTAL 150 mg -> 300 mg Single loading dose + Q4W Subcutaneous barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 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 300 mg EXPERIMENTAL 300 mg -> 450 mg Single loading dose + Q8W Subcutaneous barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 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 then barzolvolimab 150 mg EXPERIMENTAL 150 mg -> 300 mg Q4W Subcutaneous Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 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 then barzolvolimab 300 mg EXPERIMENTAL 300 mg -> 450 mg Q4W + Q8W Subcutaneous Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 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:
  • Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (time frame: From Day 1 (first dose) to Day 85 (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/NCT06445023
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT06445023.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):
  • NCT06445023
  • ../raw/clinicaltrials/markdown/NCT06445023.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.