Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Study Snapshot

  • Program: Barzolvolimab
  • Study ID(s): NCT04538794
  • Phase: Phase 1
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Celldex Therapeutics

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: DOUBLE
  • Primary purpose: TREATMENT
  • Enrollment: 45 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 75 Years
  • Healthy volunteers: False
  • Summary: This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.

Operational design summary

  • Arms represented in current CT.gov export: 2
  • Active dose regimens represented in current local source layer: 4
  • Total study enrollment in CT.gov: 45 (ACTUAL)
  • Design interpretation: Sequential 4-cohort phase 1b IV multiple-ascending-dose study with pooled placebo control.
  • Per-arm sample size summary: 45 randomized total, with 35 barzolvolimab-treated and 10 placebo-treated overall; publication abstract also lists four dose cohorts (0.5 mg/kg Q4W, 1.5 mg/kg Q4W, 3 mg/kg Q8W, 4.5 mg/kg Q8W).
  • Arm-size evidence source: PMID 40415544 abstract plus PMCID PMC12368744 full text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
CDX-0159 EXPERIMENTAL NR NR NR CDX-0159 every 4-8 weeks 35 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Normal Saline PLACEBO_COMPARATOR NR NR NR Normal saline every 4-8 weeks 10 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • At week 12 across all barzolvolimab doses combined: 71% achieved well-controlled disease (UAS7 <= 6), 57% achieved complete response (UAS7 = 0).
  • 77% achieved well-controlled UCT (>= 12); 43% achieved complete UCT response (UCT = 16).
  • Rapid symptom reduction within 1 week; response paralleled tryptase suppression.
  • Similar response regardless of prior omalizumab use (44% of patients had prior omalizumab).

Safety

  • Well tolerated; hair color change was the most common AE (mechanism-related KIT effect).

Result source(s)

  • PMID 40415544

Endpoints

  • Primary outcomes:
  • Safety as assessed by the incidence and severity of adverse events (time frame: From Day 1 (first dose) to Day 169 (last follow-up visit))

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: Primary publication support is available in the registry (PMID 40415544).

Safety Findings

  • Safety details should be reviewed in the linked primary publication(s) for fuller interpretation beyond the CT.gov inventory layer.

Linked Evidence

  • CT.gov page: https://clinicaltrials.gov/study/NCT04538794
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT04538794.md
  • Primary publications:
  • PMID 40415544: Anti-KIT Barzolvolimab for Chronic Spontaneous Urticaria. (../raw/publications/pubmed/markdown/PMID40415544.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 already has direct manuscript support in the local source layer and should be a higher-priority candidate for manual enrichment.
  • 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 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):
  • NCT04538794
  • ../raw/clinicaltrials/markdown/NCT04538794.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.