A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent

• Must have completed 52 weeks of treatment and the 16-week follow up in either the CDX0159-12 or CDX0159-13successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).

• 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.

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

Locations
United States
Florida
Deluxe Health Center
RECRUITING
Miami Lakes
Contact Information
Primary
Celldex Therapeutics
clinicaltrials@celldex.com
844-723-9363
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2028-09
Participants
Target number of participants: 1370
Treatments
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
Related Therapeutic Areas
Hives
Chronic Spontaneous Urticaria (CSU)
Sponsors
Leads: Celldex Therapeutics

This content was sourced from clinicaltrials.gov

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