Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Conditions

• Chronic Spontaneous Urticaria

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• barzolvolimab — BIOLOGICAL
  Subcutaneous Administration
• Standard of Care — OTHER
  Observational/Standard of Care

Study Details

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Key Dates

First listed

Dec 1, 2025

Start date

Nov 25, 2025

Status verified

Jun 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

1,370 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 Observation Group
  Standard of care treatment (at least 2nd generation Type 1 antihistamines \[H1AH\] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 weeks.
• Experimental: Group 2 Barzolvolimab Retreatment Group
  Barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks

Primary Outcome Measure

Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater. [ Time Frame: From Day 1 (baseline) to Week 52. ]

Locations (28)

Find similar trials in Birmingham, AL

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