Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Study Snapshot

  • Program: Barzolvolimab
  • Study ID(s): NCT05368285
  • Phase: Phase 2
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Celldex Therapeutics

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 208 (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 assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria

Operational design summary

  • Arms represented in current CT.gov export: 6
  • Active dose regimens represented in current local source layer: 3
  • Total study enrollment in CT.gov: 208 (ACTUAL)
  • Design interpretation: Placebo-controlled 16-week core with three active barzolvolimab dose regimens, followed by re-randomized active extension reflected in the 6 CT.gov arm groups.
  • Per-arm sample size summary: Publication abstract supports placebo-controlled core randomization of 75 mg Q4W (n=53), 150 mg Q4W (n=52), 300 mg Q8W (n=51), and placebo (n=51). The currently generated 52-week CT.gov labels only map cleanly to the sustained 150 mg and 300 mg arms; the re-randomized 75 mg and placebo extension arms remain unresolved at exact row level in the current local evidence layer.
  • Arm-size evidence source: PMID 41747871 abstract.

Arms

Arm Type Dose Frequency Route Description N Evidence status
barzolvolimab 75 mg then 150 mg EXPERIMENTAL 75 mg -> 150 mg Q4W Subcutaneous barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 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 75 mg then 300 mg EXPERIMENTAL 75 mg -> 300 mg Q4W + Q8W Subcutaneous barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 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 150 mg EXPERIMENTAL 150 mg Q4W Subcutaneous barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks 52 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
barzolvolimab 300 mg EXPERIMENTAL 300 mg Q8W Subcutaneous barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks 51 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo then barzolvolimab 150 mg EXPERIMENTAL 150 mg Q4W Subcutaneous Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 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 Q4W + Q8W Subcutaneous Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 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

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • Primary endpoint met at week 12 (UAS7 change from baseline, LS mean delta versus placebo): 150 mg Q4W -12.55 (P < 0.0001), 300 mg Q8W -13.41 (P < 0.0001), 75 mg Q4W -6.60 (P = 0.0017).
  • Complete response (UAS7 = 0) at week 12: 150 mg 51.1%, 300 mg 37.5%, 75 mg 22.9%, placebo 6.4%.
  • Week 52 sustained results (all patients on 150 mg or 300 mg): up to 71% complete response, up to 74% well-controlled disease, with early gains visible from week 1.
  • EADV 2025 sponsor poster indicates similarly strong efficacy in low-IgE and normal/high-IgE subgroups at weeks 12 and 52, supporting activity beyond a narrow biomarker-defined subset.
  • Week 76 off-treatment follow-up: up to 41% maintained complete response (UAS7 = 0); 69% of Week 52 responders still well-controlled; suggestive of disease modification.

Safety

  • Hair color changes (26%), neutropenia (17%), skin hypopigmentation (13%); all mechanism-related, mostly Grade 1, reversible upon discontinuation.
  • AEs were not dose-dependent; no association between infections and neutropenia.
  • Treatment-related SAEs: 2 (1%) across 156 barzolvolimab-treated patients.

Result source(s)

  • PMID 41747871
  • raw/sponsors/kit/barzolvolimab/aaaai-2025-csu-poster.md
  • raw/sponsors/kit/barzolvolimab/eadv-2024-congress-presentation.md
  • raw/sponsors/kit/barzolvolimab/eadv-2025-csu-ige-poster.md

Endpoints

  • Primary outcomes:
  • Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (time frame: From baseline to Day 85 (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: Primary publication support is available in the registry (PMID 41747871).

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/NCT05368285
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05368285.md
  • Primary publications:
  • PMID 41747871: Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria. (../raw/publications/pubmed/markdown/PMID41747871.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):
  • NCT05368285
  • ../raw/clinicaltrials/markdown/NCT05368285.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.