A Phase 3 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria (EMBARQ – CSU2)

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study toAssess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU2)

• IRAS ID

  1010208

• Contact name

  Clinical Development

• Contact email

  clinicaltrials@celldex.com

• Sponsor organisation

  Celldex Therapeutics, Inc.

• Clinicaltrials.gov Identifier

  NCT06445023

• Research summary

  Chronic Urticaria (CU) is a condition driven by Mast Cells (MCs) causing symptoms like wheals, angioedema, or both, and is classified as acute or chronic based on the duration, with CU lasting more than 6 weeks. Chronic Spontaneous Urticaria (CSU) is a self-limited disorder in most cases, but some patients have symptoms for years or even decades. Current treatments can control the disease for about two-thirds of patients. However, around 61% of patients don't see improvement with standard antihistamine doses, and 63% of those find relief when the dosage is increased.
  The main aim of this study is to test a new medicine called barzolvolimab (also known as CDX-0159) to see if it helps people with CSU. Approximately 915 participants will take part in this study.
  The study will consist of three main phases - placebo-controlled treatment phase; active treatment phase and a follow-up phase. The Placebo-Controlled Phase will last 24 weeks. Participants will have 7 site visits over the 24 weeks. During the Placebo-Controlled Treatment Phase, study drug will be given as 3 injections at the first treatment and then 2 injections after that. Participants will receive treatment once every 4 weeks over a period of 24 weeks. There are 2 different dose levels of barzolvolimab being tested. The Active Treatment phase will last 28 weeks and will begin at Week 24. There is no placebo during this phase so all participants will receive barzolvolimab. Study drug will be given as 3 injections at the first treatment and then 2 injections after that. Participants will receive treatment once every 4 weeks over a period of 28 weeks. After this participants will have 4 site visits following treatment over 16 weeks.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  24/LO/0713

• Date of REC Opinion

  6 Nov 2024

• REC opinion

  Further Information Favourable Opinion