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ClinPharm Vault

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

Study Snapshot

  • Program: Barzolvolimab
  • Study ID(s): NCT05405660
  • Phase: Phase 2
  • Indication: Chronic Inducible Urticaria
  • Status: Completed
  • Sponsor: Celldex Therapeutics

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 196 (ACTUAL)

Population

  • Conditions: Chronic Inducible Urticaria
  • Sex: ALL
  • Age range: 18 Years to None
  • Healthy volunteers: False
  • Summary: The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Operational design summary

  • Arms represented in current CT.gov export: 6
  • Active dose regimens represented in current local source layer: 2
  • Total study enrollment in CT.gov: 196 (ACTUAL)
  • Design interpretation: Phase 2 randomized dose-finding CIndU study run as two parallel 3-arm strata, one in ColdU and one in symptomatic dermographism.
  • Per-arm sample size summary: ACAAI poster text supports ColdU n=96 split as 150 mg Q4W n=32, 300 mg Q8W n=32, placebo n=32, and symptomatic dermographism n=97 split as 150 mg Q4W n=33, 300 mg Q8W n=33, placebo n=31.
  • Arm-size evidence source: Celldex Phase 2 CIndU ACAAI poster text cached locally.

Arms

Arm Type Dose Frequency Route Description N Evidence status
barzolvolimab 150 mg in patients with Symptomatic Dermographism EXPERIMENTAL 150 mg Q4W Subcutaneous barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks 33 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
barzolvolimab 300 mg in patients with Symptomatic Dermographism EXPERIMENTAL 300 mg Q8W Subcutaneous barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks 33 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo Comparator in patients with Symptomatic Dermographism PLACEBO_COMPARATOR NR Q4W Subcutaneous Placebo injection subcutaneous every 4 weeks for 20 weeks 31 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria EXPERIMENTAL 150 mg Q4W Subcutaneous barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks 32 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria EXPERIMENTAL 300 mg Q8W Subcutaneous barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks 32 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo Comparator in patients with Chronic Inducible Cold Urticaria PLACEBO_COMPARATOR NR Q4W Subcutaneous Placebo injection subcutaneous every 4 weeks for 20 weeks 32 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key Efficacy and Safety Findings

  • Result status: Conference

Efficacy

  • Primary endpoint (negative provocation test at week 12) -- Cold urticaria: 150 mg Q4W 53.1%, 300 mg Q8W 46.9%, placebo 12.5%.
  • Symptomatic dermographism: 150 mg Q4W 57.6%, 300 mg Q8W 42.4%, placebo 3.2%.
  • Critical Temperature Threshold (ColdU) LS mean change at week 12: 150 mg -9.61 C, 300 mg -8.82 C versus placebo -0.82 C (both P < 0.0001).
  • Critical Friction Threshold (SD) LS mean change at week 12: 150 mg -2.46 pins, 300 mg -2.27 pins versus placebo -0.30 pins (both P < 0.0001 and P = 0.0002).
  • Week 20: complete response up to 66% ColdU, 49% SD.

Safety

  • 98% of TEAEs were Grade 1 or 2; hair color changes 13% (versus 0% placebo), neutropenia 10% (versus 0% placebo).
  • No difference in AE-related discontinuation rates between active (2%) and placebo (3%).

Result source(s)

  • raw/sponsors/kit/barzolvolimab/phase-2-cindu-acaai-poster.md
  • raw/sponsors/kit/barzolvolimab/ir-press-release-pdf-additional-data.md

Endpoints

  • Primary outcomes:
  • Percentage of patients with a negative provocation test at week 12 (time frame: From baseline to week 12)

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/NCT05405660
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05405660.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):
  • NCT05405660
  • ../raw/clinicaltrials/markdown/NCT05405660.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.