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

NCT06455202 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 976

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

barzolvolimab

Subcutaneous Administration

BIOLOGICAL

Matching placebo

Matching placebo Subcutaneous Administration

Sponsors & Collaborators

  • Celldex Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2026-10-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Georgia
  • Germany
  • Hungary
  • India
  • Italy
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Slovakia
  • Spain
  • Thailand
  • Tunisia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455202 on ClinicalTrials.gov