Actively Recruiting
Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Not Controlled by H1-antihistamines A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
Led by Celldex Therapeutics · Updated on 2026-06-03
240
Participants Needed
73
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the activity and safety of barzolvolimab compared to placebo in adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how barzolvolimab works in these conditions. Participants are adults diagnosed with these conditions for at least three months and still symptomatic despite treatment. The study includes a screening period of up to 4 weeks, followed by a 24-week treatment period where participants receive either barzolvolimab or placebo. Those receiving barzolvolimab get a 450mg injection at the start, then 150mg every 4 weeks. After this, all participants enter a 28-week treatment phase receiving 300mg barzolvolimab every 8 weeks. Finally, there is a 16-week follow-up period where all patients are observed. During the trial, participants will complete daily symptom diaries and attend study visits for assessments. Researchers will measure responses to provocation tests at weeks 4, 12, and 24, symptom improvements like itch and hives, and changes in temperature and friction thresholds. Quality of life related to skin conditions will also be evaluated. Blood tests and liver function will be monitored, and safety will be closely followed throughout the study and follow-up periods.
CONDITIONS
Brief 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 aged 18 years or older
- Diagnosis of cold induced urticaria or symptomatic dermographism for at least 3 months
- Persistent symptoms despite stable use of second generation non-sedating H1-antihistamines for at least 4 weeks
- Presence of hives for at least 6 weeks prior to study despite H1-antihistamine use
- Cold induced urticaria participants must have a Critical Threshold Temperature between 15C and 37C and an itch score of 5 or more after provocation
- Symptomatic dermographism participants must have a Critical Friction Threshold of 3 or more and an itch score of 5 or more after provocation
- Positive ice-cube test causing hives at the provocation site during screening for cold induced urticaria
- Normal blood counts and liver function tests
- Agreement to use highly effective contraceptives during and for 150 days after treatment for participants of child-bearing potential
- Willingness and ability to complete a daily symptom electronic diary and attend study visits
- Participants with or without prior biologic treatment experience
You will not qualify if you...
- Women who are pregnant or nursing
- Known cause for chronic urticaria other than cold induced urticaria or symptomatic dermographism
- Active itchy skin conditions other than cold induced urticaria or symptomatic dermographism
- Medical conditions that increase risk or interfere with study procedures
- Known infection with HIV, hepatitis B, or hepatitis C
- Vaccination with live vaccine within 30 days before screening or planned during study
- History of anaphylaxis except due to cold exposure over large body areas
- Prior treatment with barzolvolimab
- Other criteria as determined by the study doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive barzolvolimab or placebo injections to assess efficacy and safety for cold induced urticaria or symptomatic dermographism.
Injections every 4 weeks during this period
Duration - 28 weeks
Participants continue treatment with barzolvolimab injections at a different dosing schedule.
Injections every 8 weeks during this period
Duration - 16 weeks
Participants are observed for safety and outcomes after treatment ends.
Follow-up visits during this period
Trial Site Locations
Total: 73 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, Klinik für Dermatologie und Allergologie
Augsburg, Germany
Not Yet Recruiting
28
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP Immunologie und Allergologie IA c/o Charité - Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
29
Elbe Kliniken Buxtehude Dermatologie
Buxtehude, Germany
Actively Recruiting
30
Rosenpark Research GmbH
Darmstadt, Germany
Actively Recruiting
31
Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Dermatologie
Dresden, Germany
Actively Recruiting
32
Department of Dermatology, University Hospital Dusseldorf
Düsseldorf, Germany
Not Yet Recruiting
33
Hautklinik, Uniklinkum Erlangen
Erlangen, Germany
Not Yet Recruiting
34
Universitätsklinikum Göttingen
Göttingen, Germany
Not Yet Recruiting
35
Universitätsklinikum Heidelberg, Klinik für Dermatologie
Heidelberg, Germany
Not Yet Recruiting
36
MVZ DermaKiel GmbH
Kiel, Germany
Actively Recruiting
37
Universitätsklinikum Schleswig-Holstein Universität zu Lübeck - Campus Lübeck
Lübeck, Germany
Actively Recruiting
38
Klinik und Poliklinik für Dermatologie und Allergologie, LMU Klinikum; DASZ-Dermato-Allergologisches Studienzentrum
München, Germany
Actively Recruiting
39
Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie
Münster, Germany
Not Yet Recruiting
40
Universitäts-Hautklinik Tübingen Studienzentrum Immundermatologie
Tübingen, Germany
Actively Recruiting
41
CD8 Klinika
Kaunas, Lithuania
Actively Recruiting
42
UAB Ausros Medicinos Centras
Kaunas, Lithuania
Actively Recruiting
43
Santaros KTC (klinikiniu tyrimu centras)
Vilnius, Lithuania
Actively Recruiting
44
UAB Alerginių susirgimų diagnostikos ir gydymo centras
Vilnius, Lithuania
Actively Recruiting
45
Synexus Polska Sp. z o.o. Oddział w Gdańsku
Gdansk, Poland, 80-382
Actively Recruiting
46
Centrum Badań Klinicznych PI-House Sp. z o.o.
Gdansk, Poland, 80-546
Actively Recruiting
47
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow, Poland
Actively Recruiting
48
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, Poland
Actively Recruiting
49
Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
Lodz, Poland
Not Yet Recruiting
50
Santa Familia PTG Lodz
Lodz, Poland
Actively Recruiting
51
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
Lublin, Poland
Not Yet Recruiting
52
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Not Yet Recruiting
53
Medicome Sp. z o.o.
Oświęcim, Poland
Actively Recruiting
54
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
Poznan, Poland
Not Yet Recruiting
55
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie; Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów, Poland
Not Yet Recruiting
56
Alergo-med Ośrodek Badań Klinicznych Sp. z o. o.
Tarnów, Poland
Actively Recruiting
57
MICS Centrum Medyczne Toruń
Torun, Poland
Actively Recruiting
58
Klinika Ambroziak Dermatologia
Warsaw, Poland
Actively Recruiting
59
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
Wroclaw, Poland
Actively Recruiting
60
Worthwhile Clinical Trials
Benoni, South Africa
Actively Recruiting
61
Allergy & Immunology Unit, University of Cape Town Lung Institute
Cape Town, South Africa
Actively Recruiting
62
Dr. PJ Sebastian
Durban, South Africa
Actively Recruiting
63
Infinity Dermatology Inc
Durban, South Africa
Actively Recruiting
64
Synapta Clinical Research Centre
Durban, South Africa
Actively Recruiting
65
Newtown Clinical Research Centre
Johannesburg, South Africa
Actively Recruiting
66
Sandton Medical Research Centre
Johannesburg, South Africa
Actively Recruiting
67
Global Clinical Trials (Pty) Ltd
Pretoria, South Africa
Actively Recruiting
68
Allergy and Asthma Centre
Westville, South Africa
Actively Recruiting
69
Hospital del Mar
Barcelona, Spain
Actively Recruiting
70
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
71
Addenbrooke's Hospital
Cambridge, United Kingdom
Not Yet Recruiting
72
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Not Yet Recruiting
73
Salford Care Organisation NCA NHS Trust
Manchester, United Kingdom
Not Yet Recruiting
Research Team
C
Celldex Therapeutics
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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