Actively Recruiting
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Led by Celldex Therapeutics · Updated on 2026-05-08
240
Participants Needed
72
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
CONDITIONS
Official Title
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 18 years of age or older
- Diagnosis of cold induced urticaria or symptomatic dermographism for at least 3 months
- Presence of hives for at least 6 weeks despite using H1-antihistamines
- Stable regimen of second generation non-sedating H1-antihistamines for at least 4 weeks before treatment
- For cold induced urticaria, Critical Threshold Temperature between 15 6C and less than 37 6C and itch score of 5 or more after provocation test
- For symptomatic dermographism, Critical Friction Threshold of 3 or more and itch score of 5 or more after provocation test
- Positive ice-cube test with hives at provocation site during screening for cold induced urticaria
- Normal blood counts and liver function tests
- Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for at least 150 days after treatment
- Willing and able to complete a daily symptom electronic diary and comply with study visits
- Participants with or without prior biologic experience are eligible
You will not qualify if you...
- Women who are pregnant or nursing
- Clearly defined cause for chronic urticaria
- Active, itchy skin condition in addition to cold induced urticaria or symptomatic dermographism
- Medical conditions that increase risk or interfere with study procedures
- Known HIV, hepatitis B, or hepatitis C infection
- Vaccination with a live vaccine within 30 days prior to screening or during the study
- History of anaphylaxis unless due to cold exposure over a large part of the body
- Prior treatment with barzolvolimab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 72 locations
1
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States, 35244
Actively Recruiting
2
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Kern Research, Inc.
Bakersfield, California, United States, 93301
Actively Recruiting
4
One of a Kind Clinical Research Center
Napa, California, United States, 94558
Actively Recruiting
5
Allergy & Asthma Consultants
Redwood City, California, United States, 94063
Actively Recruiting
6
Amicis Research Center
Sherman Oaks, California, United States, 91403
Actively Recruiting
7
FOMAT - Allergy, Asthma & Immunology Medical Group
Ventura, California, United States, 93003
Actively Recruiting
8
Direct Helpers Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
9
Well Pharma Medical Research, Corp.
Miami, Florida, United States, 33143
Actively Recruiting
10
Deluxe Health Center, LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
11
GCP, Global Clinical Professionals
St. Petersburg, Florida, United States, 33705
Actively Recruiting
12
Advanced Clinical Research Institute
Tampa, Florida, United States, 33607
Actively Recruiting
13
Centricity Research Columbus Dermatology
Columbus, Georgia, United States, 31904
Actively Recruiting
14
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Actively Recruiting
15
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States, 60077
Actively Recruiting
16
Equity Medical, LLC
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
17
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, United States, 40207
Actively Recruiting
18
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
19
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
Actively Recruiting
20
Equity Medical, LLC
New York, New York, United States, 10023
Actively Recruiting
21
Markowitz Medical PLLC dba OptiSkin Medical
New York, New York, United States, 10128
Actively Recruiting
22
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
23
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
24
Advanced Dermatology and Cosmetic Surgery - Spartanburg
Spartanburg, South Carolina, United States, 29307
Actively Recruiting
25
RFSA Dermatology
San Antonio, Texas, United States, 78212
Actively Recruiting
26
Allergy Associates of Utah
Sandy City, Utah, United States, 84093
Actively Recruiting
27
Universitätsklinikum Augsburg - III. Med. Klinik
Augsburg, Germany
Not Yet Recruiting
28
Institut für Allergieforschung (IFA) Charité - Universitätsmedizin Berlin
Berlin, Germany
Not Yet Recruiting
29
Elbekliniken Buxtehude
Buxtehude, Germany
Actively Recruiting
30
Rosenpark Research
Darmstadt, Germany
Actively Recruiting
31
University Hospital Dresden
Dresden, Germany
Not Yet Recruiting
32
University Hospital Düsseldorf
Düsseldorf, Germany
Not Yet Recruiting
33
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen, Germany
Not Yet Recruiting
34
Universitätsklinikum Göttingen
Göttingen, Germany
Not Yet Recruiting
35
Universitätsklinikum Heidelberg
Heidelberg, Germany
Not Yet Recruiting
36
MVZ DermaKiel GmbH
Kiel, Germany
Not Yet Recruiting
37
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Actively Recruiting
38
LMU Klinikum der Universität
München, Germany
Not Yet Recruiting
39
Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie
Münster, Germany
Actively Recruiting
40
Universitäts-Hautklinik Tübingen
Tübingen, Germany
Actively Recruiting
41
CD8 Klinika
Kaunas, Lithuania
Actively Recruiting
42
UAB Ausros Medicinos Centras
Kaunas, Lithuania
Actively Recruiting
43
Republic Klaipeda Hospital
Klaipėda, Lithuania
Not Yet Recruiting
44
Santaros KTC (klinikiniu tyrimu centras)
Vilnius, Lithuania
Actively Recruiting
45
UAB Alerginių susirgimų diagnostikos ir gydymo centras
Vilnius, Lithuania
Actively Recruiting
46
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow, Poland
Not Yet Recruiting
47
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, Poland
Actively Recruiting
48
"Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi"
Lodz, Poland
Not Yet Recruiting
49
Santa Familia PTG Lodz
Lodz, Poland
Actively Recruiting
50
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
Lublin, Poland
Not Yet Recruiting
51
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Not Yet Recruiting
52
Medicome Sp. z o.o.
Oświęcim, Poland
Actively Recruiting
53
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
Poznan, Poland
Not Yet Recruiting
54
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, Poland
Not Yet Recruiting
55
Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością
Tarnów, Poland
Not Yet Recruiting
56
MICS Centrum Medyczne Toruń
Torun, Poland
Not Yet Recruiting
57
Klinika Ambroziak Dermatologia
Warsaw, Poland
Actively Recruiting
58
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Sp. Partnerska
Wroclaw, Poland
Actively Recruiting
59
Worthwhile Clinical Trials
Benoni, South Africa
Not Yet Recruiting
60
Allergy and Immunology Unit, University of Cape Town Lung Institute (UCTLI)
Cape Town, South Africa
Actively Recruiting
61
Dr. PJ Sebastian
Durban, South Africa
Actively Recruiting
62
Infinity Dermatology Inc
Durban, South Africa
Actively Recruiting
63
Synapta Clinical Research Centre
Durban, South Africa
Actively Recruiting
64
Newtown Clinical Research Centre
Johannesburg, South Africa
Actively Recruiting
65
Sandton Medical Research Centre
Johannesburg, South Africa
Actively Recruiting
66
Global Clinical Trials (Pty) Ltd
Pretoria, South Africa
Actively Recruiting
67
Allergy and Asthma Centre
Westville, South Africa
Actively Recruiting
68
Hospital del Mar
Barcelona, Spain
Actively Recruiting
69
Clinica Universidad Navarra - Pamplona
Pamplona, Spain
Actively Recruiting
70
Addenbrooke's Hospital
Cambridge, United Kingdom
Not Yet Recruiting
71
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Not Yet Recruiting
72
Salford Care Organisation NCA NHS Trust
Manchester, United Kingdom
Not Yet Recruiting
Research Team
C
Celldex Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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