Chronic Inducible UrticariaPhase 3NCT07266402
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)
A Phase 3 study testing Barzolvolimab in people with Chronic Inducible Urticaria and Cold Urticaria, run by Celldex Therapeutics at 72 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria
- What is being tested?
- Barzolvolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 72 sitesin 7 countries
- Study dates
- 15 Jan 2026to Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, >/= 18 years of age.
- Diagnosis of cold induced urticaria or symptomatic dermographism >/= 3 months.
- Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
- Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
- Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and < 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.
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- Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.
- Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
- 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 ≥ 150 days after treatment.
- Willing and able to complete a daily symptom electronic diary and comply with study visits.
- Participants with and without prior biologic experience are eligible.
Who cannot join
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
- Medical condition that would cause additional 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 (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
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- History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).
- Prior treatment with barzolvolimab
- There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Trial locations and contacts
72 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
72 sites in 7 countries
United States26 sites, 26 recruiting
- Recruiting
Kern Research, Inc.
Bakersfield, California, 93301
Wandy Noriega, wandy.noriega@kernresearch.com
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21224
Kellie Devine, kdevine1@jhmi.edu
- Recruiting
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, 35244
Jennifer Perry, jperry@cahabaderm.com
- Recruiting
Treasure Valley Medical Research
Boise, Idaho, 83706
Jackie Allen, jallen@tvmedresearch.com
- Recruiting
Equity Medical, LLC
Bowling Green, Kentucky, 42104
Kristen Newman, knewman@equity-med.com
- Not yet recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
- Recruiting
Centricity Research Columbus Dermatology
Columbus, Georgia, 31904
Cheyenne Dempsey, cheyenne.dempsey@centricityresearch.com
- Recruiting
Direct Helpers Research Center
Hialeah, Florida, 33012
Monica Merino-Lopez, monica@dhrtrials.com
- Recruiting
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, 40207
Rhonda Dase, rdase@advancedentandallergy.com
- Recruiting
Well Pharma Medical Research, Corp.
Miami, Florida, 33143
Yudesiy Izquierdo, yizquierdo@wpharma.com
- Recruiting
Deluxe Health Center, LLC
Miami Lakes, Florida, 33014
Leidy Caballero, lcaballero@deluxehealthcenter.com
- Recruiting
One of a Kind Clinical Research Center
Napa, California, 94558
Michelle Humbard, michelle@1-oak.net
- Recruiting
Equity Medical, LLC
New York, New York, 10023
Adugna Deboch, adugna.getahun@primeglobalresearch.com
- Recruiting
Markowitz Medical PLLC dba OptiSkin Medical
New York, New York, 10128
Nathan Schwab, nathan@optiskinmedical.com
- Recruiting
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Meryem Assaoui, meryem@mtarpay.com
- Recruiting
Allergy & Asthma Consultants
Redwood City, California, 94063
Sherry Lipson, sherry.lipsonallergy@gmail.com
- Recruiting
RFSA Dermatology
San Antonio, Texas, 78212
Jonathan Joseph, jonathanj.rfsadermatology@gmail.com
- Recruiting
Allergy Associates of Utah
Sandy City, Utah, 84093
Holly Anderson, holly.anderson@utahallergies.com
- Recruiting
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona, 85258
Jordan Byers, jordan@1-oak.net
- Recruiting
Amicis Research Center
Sherman Oaks, California, 91403
William Calder, w.calder@amicisresearch.com
- Recruiting
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077
Alba Berty, alba.berty@endeavorhealth.org
- Recruiting
Advanced Dermatology and Cosmetic Surgery - Spartanburg
Spartanburg, South Carolina, 29307
Rion Allen, rion.allen@adcsclinics.com
- Recruiting
GCP, Global Clinical Professionals
St. Petersburg, Florida, 33705
Nailis Echevarria, nechevarria@researchgcp.com
- Recruiting
Advanced Clinical Research Institute
Tampa, Florida, 33607
Lisbet Rodriguez, lisbet@acrinstitute.com
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
Ria Abraham, rabraham@rev-research.com
- Recruiting
FOMAT - Allergy, Asthma & Immunology Medical Group
Ventura, California, 93003
Thai Orantes, torantes@fomatmedical.com
Germany14 sites, 14 recruiting
- Recruiting
Universitätsklinikum Augsburg, Klinik für Dermatologie und Allergologie
Augsburg
Julia Grabowski, julia.grabowski@uk-augsburg.de
- Recruiting
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP Immunologie und Allergologie IA c/o Charité - Universitätsmedizin Berlin
Berlin
Natascha Koculak, natascha.koculak@itmp.fraunhofer.de
- Recruiting
Elbe Kliniken Buxtehude Dermatologie
Buxtehude
Dana Etz, dana.etz@elbekliniken.de
- Recruiting
Rosenpark Research GmbH
Darmstadt
Christine Muetschard, christine.muetschard@rosenparkresearch.de
- Recruiting
Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Dermatologie
Dresden
Katharina Blümlein, katharina.bluemlein@ukdd.de
- Recruiting
Department of Dermatology, University Hospital Dusseldorf
Düsseldorf
Mayumi Waldmann, mayumi.waldmann@med.uni-duesseldorf.de
- Recruiting
Hautklinik, Uniklinkum Erlangen
Erlangen
Stephanie Dierke, stephanie.dierke@uk-erlangen.de
- Recruiting
Universitätsklinikum Göttingen -- George-August-Universitat Göttinggen, Klinik für Dermatoogie, Venerologie und Allergologie
Göttingen
Kerstin Specht, kerstin.specht@med.uni-goettingen.de
- Recruiting
Universitätsklinikum Heidelberg, Klinik für Dermatologie
Heidelberg
Irina Greilich, irina.greilich@med.uni-heidelberg.de
- Recruiting
MVZ DermaKiel GmbH
Kiel
Birgit Johannsson, stud.birgit.johannsson@gmx.de
- Recruiting
Universitätsklinikum Schleswig-Holstein Universität zu Lübeck - Campus Lübeck
Lübeck
Lena Pommerien, malena.pommerien@uksh.de
- Recruiting
Klinik und Poliklinik für Dermatologie und Allergologie, LMU Klinikum; DASZ-Dermato-Allergologisches Studienzentrum
München
Julia Morgenstern, julia.morgenstern@med.uni-muenchen.de
- Recruiting
Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie
Münster
Katrin Kieslich, katrin.kieslich@ukmuenster.de
- Recruiting
Universitäts-Hautklinik Tübingen Studienzentrum Immundermatologie
Tübingen
Gabriele Blank, gabriele.blank@med.uni-tuebingen.de
Poland14 sites, 14 recruiting
- Recruiting
Synexus Polska Sp. z o.o. Oddział w Gdańsku
Gdansk, 80-382
Magdalena Rodzik, magdalena.rodzik@trialmed.com
- Recruiting
Centrum Badań Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546
Alicja Kubiak, a.kubiak@pihouse.pl
- Recruiting
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow
Dominika Olejniczak, dominika.olejniczak@gazeta.pl
- Recruiting
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow
Piotr Zurek, m.poczatko@dobrylekarz.com.pl
- Recruiting
Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w todzi, Oddziat Kliniczny Choréb Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci
Lodz
Joanna Molińska, joanna.molinska@umed.lodz.pl
- Recruiting
Santa Familia PTG Lodz
Lodz
Kamila Musial, kamila.musial@ptg-network.com
- Recruiting
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
Lublin
Aleksandra Pacion, aleksandra.pacion86@gmail.com
- Recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole
Eliza Kaczanowska-Grabowska
- Recruiting
Medicome Sp. z o.o.
Oświęcim
Anna Olejniczak, aolejniczak@medicome.pl
- Recruiting
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie; Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów
Magdalena Sapa, sapamagdalena97@gmail.com
- Recruiting
Alergo-med Ośrodek Badań Klinicznych Sp. z o. o.
Tarnów
Anna Maj, anna.maj@alergo-med.eu
- Recruiting
MICS Centrum Medyczne Toruń
Torun
Anna Mazur, anna.mazur@mics.medicover.com
- Recruiting
Klinika Ambroziak Dermatologia
Warsaw
Michał Korolczuk, michal@klinikaambroziak.pl
- Recruiting
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
Wroclaw
Marta Zaleska, marta.zaleska.work@gmail.com
South Africa9 sites, 9 recruiting
- Recruiting
Worthwhile Clinical Trials
Benoni
Mageshni Iyer, mageshni@wwct.co.za
- Recruiting
Allergy & Immunology Unit, University of Cape Town Lung Institute
Cape Town
Juliet Esterhuizen, juliet.esterhuizen@uct.ac.za
- Recruiting
Dr. PJ Sebastian
Durban
Deborah Amy Sebastian, dasebastian@iafrica.com
- Recruiting
Infinity Dermatology Inc
Durban
Kufanelesibonge Mafoko, bmfanelo@yahoo.com
- Recruiting
Synapta Clinical Research Centre
Durban
Sibongile Gloria Lembethe, sibongile@synapta.co.za
- Recruiting
Newtown Clinical Research Centre
Johannesburg
Busisiwe Zwane, busisiwezwane@ymail.com
- Recruiting
Sandton Medical Research Centre
Johannesburg
Nomsa Tshetlo, n.tshetlo@smrc.co.za
- Recruiting
Global Clinical Trials (Pty) Ltd
Pretoria
Priscilla Diakanyo Kwati, priscilla@gctrials.co.za
- Recruiting
Allergy and Asthma Centre
Westville
Nothile Dlamini, nothiled@outlook.com
Lithuania4 sites, 4 recruiting
- Recruiting
CD8 Klinika
Kaunas
Ina Miteleva, registracija@cd8klinika.lt
- Recruiting
UAB Ausros Medicinos Centras
Kaunas
Margarita Paulauskiene, paulauskiene.margarita@gmail.com
- Recruiting
Santaros KTC (klinikiniu tyrimu centras)
Vilnius
Linas Liekis, linas.liekis@inlita.lt
- Recruiting
UAB Alerginių susirgimų diagnostikos ir gydymo centras
Vilnius
Auksė Zinkevičienė, aukse.zinkeviciene@gmail.com
United Kingdom3 sites, 3 recruiting
- Recruiting
I&I Research Department
Cambridge, CB2 0QQ
Kayleigh Atkinson, kayleigh.atkinson5@nhs.net
- Recruiting
Glasgow Clinical Research Facility, Institute of Neurological Science, Queen Elizabeth University Hospital
Glasgow, G51 4TF
Jasmine Leighton, jasmine.leighton2@nhs.scot
- Recruiting
Dermatopharmacology Unit, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Manchester
Jacqueline Howe, jacqueline.howe@manchester.ac.uk
Spain2 sites, 2 recruiting
- Recruiting
Hospital del Mar
Barcelona
Montserrat Barber Gonzalez, mbarber@researchmar.cat
- Recruiting
Clinica Universidad de Navarra
Pamplona
Iker Azparren Diaz, iazparren@unav.es
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)
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.
Read the detailed description
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 (ColdU) or symptomatic dermographism (SD) who remain symptomatic despite the use of H1-antihistamines.
There is a Screening Period of up to 4 weeks, followed by a 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg every 4 weeks. Then there is a 28-week treatment period where all patients will receive 300mg barzolvolimab every 8 weeks, followed by a 16-week follow-up period where all patients are observed.
- Conditions
- Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
- Being tested
- Barzolvolimab, Matching Placebo
- Keywords
- Chronic Inducible urticaria, cold urticaria, cold-induced urticaria, ColdU, symptomatic dermographism,, SD, barzolvolimab, CDX0159, CDX-0159
- Medical subject headings
- Chronic Inducible Urticaria, Cold Urticaria, Familial dermographism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarzolvolimabDrug
Also called CDX-0159
Subcutaneous Administration
Matching PlaceboDrug
Subcutaneous Administration
| Study group | Role | What they receive |
|---|---|---|
| barzolvolimab in patients with Cold Induced Urticaria | Experimental | barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. Receives: Drug: Barzolvolimab |
| Placebo in patients with Cold Induced Urticaria | Placebo comparator | Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. Receives: Drug: Matching Placebo |
| barzolvolimab in patients with Symptomatic Dermographism | Experimental | barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. Receives: Drug: Barzolvolimab |
| Placebo in patients with Symptomatic Dermographism | Placebo comparator | Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response to provocation testing at Week 12
Proportion of Cold Induced Urticaria [ColdU] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism [SD] participants with complete response in Critical Friction Threshold at Week 12.
- For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®
- For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
Measured: From Day 1 (first dose) to Week 12
Secondary outcomes (15)
Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
Measured: From Day 1 (first dose) to Week 24
Complete response to provocation testing at Week 24 for Symptomatic Dermographism
Proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 24. Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
Measured: From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch at Week 12
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Measured: From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of itch at Week 24
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Measured: From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch following provocation testing (WI-NRSprovo) at Week 12
Change from baseline in WI-NRSprovo at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Measured: From Day 1 (first dose) to Week 12
Complete response to provocation testing at Week 4
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 4 or proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 4
Measured: From Day 1 (first dose) to Week 4
Improvement in clinical symptoms of hives at Week 12
Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Measured: From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of hives at Week 24
Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Measured: From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 12
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 12.
CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark.
Measured: From Day 1 (first dose) to Week 12
Change from baseline in Critical Friction Threshold (CFT) at Week 12
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 12.
CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark.
Measured: From Day 1 (first dose) to Week 12
Change from baseline in Critical Temperature Threshold (CTT) at Week 24
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 24.
Measured: From Day 1 (first dose) to Week 24
Change from baseline in Critical Friction Threshold (CFT) at Week 24
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 24.
Measured: From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 4
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 4.
Measured: From Day 1 (first dose) to Week 4
Change from baseline in Critical Friction Threshold (CFT) at Week 4
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 4.
Measured: From Day 1 (first dose) to Week 4
Improvement in Dermatology Quality of Life Index (DLQI) at Week 12
Proportion of participants with DLQI = 0-1 at Week 12.
Measured: From Day 1 (first dose) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inducible UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266402
- Sponsor's protocol ID
- CDX0159-16
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)
- ClinicalTrials.gov ID
- NCT07266402
- Acronym / sponsor ID
- CDX0159-16
- Conditions
- Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
- Keywords
- Chronic Inducible urticaria, cold urticaria, cold-induced urticaria, ColdU, symptomatic dermographism,, SD, barzolvolimab, CDX0159
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (ColdU) or symptomatic dermographism (SD) who remain symptomatic despite the use of H1-antihistamines.
There is a Screening Period of up to 4 weeks, followed by a 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg every 4 weeks. Then there is a 28-week treatment period where all patients will receive 300mg barzolvolimab every 8 weeks, followed by a 16-week follow-up period where all patients are observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| barzolvolimab in patients with Cold Induced Urticaria | Experimental | Drug: Barzolvolimabbarzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| Placebo in patients with Cold Induced Urticaria | Placebo comparator | Drug: Matching PlaceboPlacebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| barzolvolimab in patients with Symptomatic Dermographism | Experimental | Drug: Barzolvolimabbarzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
| Placebo in patients with Symptomatic Dermographism | Placebo comparator | Drug: Matching PlaceboPlacebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females, >/= 18 years of age.
- Diagnosis of cold induced urticaria or symptomatic dermographism >/= 3 months.
- Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
- Normal blood counts and liver function tests.
Key exclusion criteria (9 listed)
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known HIV, hepatitis B or hepatitis C infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BarzolvolimabAlso: CDX-0159Subcutaneous Administration | Drug | barzolvolimab in patients with Cold Induced Urticaria, barzolvolimab in patients with Symptomatic Dermographism |
| Matching PlaceboSubcutaneous Administration | Drug | Placebo in patients with Cold Induced Urticaria, Placebo in patients with Symptomatic Dermographism |
Primary outcome
Complete response to provocation testing at Week 12
Time frame: From Day 1 (first dose) to Week 12
Proportion of Cold Induced Urticaria [ColdU] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism [SD] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
15 secondary outcomes
Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants
Time frame: From Day 1 (first dose) to Week 24
Complete response to provocation testing at Week 24 for Symptomatic Dermographism
Time frame: From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch at Week 12
Time frame: From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of itch at Week 24
Time frame: From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch following provocation testing (WI-NRSprovo) at Week 12
Time frame: From Day 1 (first dose) to Week 12
Complete response to provocation testing at Week 4
Time frame: From Day 1 (first dose) to Week 4
Improvement in clinical symptoms of hives at Week 12
Time frame: From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of hives at Week 24
Time frame: From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 12
Time frame: From Day 1 (first dose) to Week 12
Change from baseline in Critical Friction Threshold (CFT) at Week 12
Time frame: From Day 1 (first dose) to Week 12
Change from baseline in Critical Temperature Threshold (CTT) at Week 24
Time frame: From Day 1 (first dose) to Week 24
Change from baseline in Critical Friction Threshold (CFT) at Week 24
Time frame: From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 4
Time frame: From Day 1 (first dose) to Week 4
Change from baseline in Critical Friction Threshold (CFT) at Week 4
Time frame: From Day 1 (first dose) to Week 4
Improvement in Dermatology Quality of Life Index (DLQI) at Week 12
Time frame: From Day 1 (first dose) to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
72 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Barzolvolimab in people with Chronic Inducible Urticaria and Cold Urticaria, run by Celldex Therapeutics at 72 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Germany, Poland, South Africa, Lithuania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celldex Therapeutics (844-723-9363, clinicaltrials@celldex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response to provocation testing at Week 12 (time frame: From Day 1 (first dose) to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.