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

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 (19)

Find similar trials in Birmingham, AL

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