Phase 3 study

By invitation Phase 3

Sources: ClinicalTrials.gov Checked: 14 October 2026 Not medical advice

This trial at a glance

Status By invitation
Phase Phase 3
Sponsor Celldex Therapeutics
Registry number NCT07256392
Started 25 November 2025 Today 16 October 2026 Estimated completion 1 September 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Cornerstone Dermatology Coorparoo QLD Status not stated
The Alfred Hospital Melbourne VIC Status not stated

voxsanity.com.au · trial sites from public registries · registry record synced 14 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1370

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

1. Written informed consent

2. Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).

3. Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.

4. Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary.

Key Exclusion Criteria:

1. Active pruritic skin condition in addition to CSU.

2. Medical condition that would cause additional risk or interfere with study procedures.

3. Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Dates on the record

Started 25 November 2025
Estimated completion 1 September 2028
Registry last updated 7 October 2026
Checked by Voxsanity 14 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 7 October 2026.
  • This page last checked by Voxsanity: 14 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.