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Chronic Inducible UrticariaPhase 2NCT05405660

A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

A Phase 2 study testing barzolvolimab in people with Chronic Inducible Urticaria, run by Celldex Therapeutics at 76 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria 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
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
196 participants
Where
76 sitesin 11 countries
Study dates
28 Jun 2022to 12 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 chronic ColdU or SD >/= 3 months.
  • Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
  • Recurrent pruritic wheals with or without angioedema due to ColdU or SD 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 and agree to stay on through trial.
  • UCT < 12 during the 14 days prior to treatment.
Show all 11Show fewer
  • Positive provocation test
  • for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3)
  • for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)
  • 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.

Who cannot join

  • Women who are pregnant or nursing.
  • Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments.
  • Active, pruritic skin condition in addition to CIndU.
  • Medical condition that would cause additional risk or interfere with study procedures.
  • Known active HIV, hepatitis B or hepatitis C infection.
  • Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
  • History of anaphylaxis
  • There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Trial locations and contacts

76 sites in 11 countries.

76 sites in 11 countries

United States16 sites

  • Kern Research, Inc

    Bakersfield, California, 93301

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35249

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • Institute for Asthma and Allergy, PC/Department of Clinical Research

    Chevy Chase, Maryland, 20815

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana, 46250

  • Allergy Partners of Kerrville

    Kerrville, Texas, 78028

  • Little Rock Allergy & Asthma CRC

    Little Rock, Arkansas, 72205

  • Allervie Clinical Research

    Montgomery, Alabama, 36106

  • Allergy Associates of Utah

    Murray, Utah, 84107

  • Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky, 42301

  • One of a Kind Clinical Research Center, LLC

    Paradise Valley, Arizona, 85253

  • Allergy & Asthma Consultants

    Redwood City, California, 94063

  • Sarasota Clinical Research

    Sarasota, Florida, 34239

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany13 sites

  • Universitätsklinikum Augsburg

    Augsburg, Bavaria, 86179

  • Institute of Allergology IFA

    Berlin, 12203

  • Elbe Klinikum Buxtehude

    Buxtehude, Lower Saxony, 21614

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Düsseldorf - Dermatologie

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr

    Essen, North Rhine-Westphalia, 45122

  • Hannover Medical University

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Heidelberg - Dermatologie

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsklinikum Giessen u. Marburg GmbH

    Marburg, Hesse, 35043

  • LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum

    München, Bavaria, 80337

  • Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie

    Oldenburg, Lower Saxony, 26133

Other trials in Germany

Poland8 sites

  • Centrum Medyczne PLEJADY

    Krakow, 30-363

  • Malopolskie Centrum Alergologii

    Krakow, 31-624

  • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

    Lodz, 90-153

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej

    Lublin, 20-573

  • Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii

    Opole, 45-401

  • Medicome Sp. z o.o.

    Oświęcim, 32600

  • Medicover Integrated Clinical Services Sp. zo.o.

    Torun, 87-100

  • Klinika Ambroziak sp. z o.o.

    Warsaw, 02-953

Other trials in Poland

South Africa8 sites

  • WorthWhile Clinical Trials

    Benoni, Gauteng, 1500

  • Iatros International

    Bloemfontein, Free State, 9324

  • The University of Cape Town - Lung Institute

    Cape Town, Mowbray, 7700

  • Synapta Clinical Research

    Durban, KwaZulu-Natal, 4001

  • Dr PJ Sebastian

    Durban, KwaZulu-Natal, 4092

  • Newtown Clinical Research

    Johannesburg, Gauteng, 2113

  • Ubuntu Clinical Research

    Lenasia, Gauteng, 1827

  • FCRN Clinical Trial Centre Vaal Triangle

    Vereeniging, Gauteng, 1935

Other trials in South Africa

Bulgaria6 sites

  • Outpatient Clinic for Individual Practice for Specialized Outpatient

    Razgrad, 7200

  • Medical Center Iskar- EOOD Office of Clinical Allergology

    Sofia, 1504

  • "Medical Center Ekselsior" OOD

    Sofia

  • "University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology

    Sofia

  • Medical Center "SYNEXUS SOFIA", EOOD

    Sofia

  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD

    Stara Zagora

Other trials in Bulgaria

Spain6 sites

  • HGU de Alicante

    Alicante, 03010

  • Hospital Bellvitge

    Barcelona, 8907

  • Hospital Vall d´ Hebron

    Barcelona, 9035

  • Universidad de Navarra

    Madrid, 28027

  • Hospital Regional Universitario de Málaga

    Málaga, 29009

  • Hospital Arnau de Vilanova

    Valencia, 46015

Other trials in Spain

Hungary5 sites

  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika

    Budapest, 1085

  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika

    Budapest

  • Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika

    Debrecen, H-4032

  • Allergo-Derm Bakos Kft

    Szolnok, 5000

  • Óbudai Egészségügyi Centrum

    Zalaegerszeg, 8900

Other trials in Hungary

Latvia5 sites

  • Balvi and Gulbene Hospital Union

    Balvi, LV-4501

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • "LOR" Clinic

    Riga, LV-1004

  • Children Clinical University Hospital

    Riga, LV-1004

  • Consilium Medicum

    Riga, LV-1010

Other trials in Latvia

Georgia4 sites

  • High Technology Hospital Medcenter

    Batumi, 6000

  • Healthy Future

    Tbilisi, 0119

  • Center of Allergy and Immunology

    Tbilisi, 0159

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

Other trials in Georgia

Lithuania3 sites

  • JSC Ausros Medicinos Centras

    Kaunas, 49387

  • JSC Inlita

    Vilnius, 08406

  • Center of Allergy Diagnosis and Treatment

    Vilnius, LT-09109

Other trials in Lithuania

Estonia2 sites

  • Vahlberg & Pild Clinic

    Tallinn, 10134

  • East Tallin Central Hospital

    Tallinn, 11312

Other trials in Estonia

About this study

Official title: : A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Read the detailed description

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold 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 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Being tested
barzolvolimab, Matching Placebo
Keywords
CDX-0159, barzolvolimab
Medical subject headings
Chronic Inducible Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • barzolvolimabBiological

    Also called CDX-0159

    Subcutaneous Administration

  • Matching PlaceboDrug

    Subcutaneous Administration

Study groups in NCT05405660
Study groupRoleWhat they receive
barzolvolimab 150 mg in patients with Symptomatic DermographismExperimentalbarzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
Receives: Biological: barzolvolimab
barzolvolimab 300 mg in patients with Symptomatic DermographismExperimentalbarzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
Receives: Biological: barzolvolimab
Placebo Comparator in patients with Symptomatic DermographismPlacebo comparatorPlacebo injection subcutaneous every 4 weeks for 20 weeks
Receives: Drug: Matching Placebo
barzolvolimab 150 mg in patients with Chronic Inducible Cold UrticariaExperimentalbarzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
Receives: Biological: barzolvolimab
barzolvolimab 300 mg in patients with Chronic Inducible Cold UrticariaExperimentalbarzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
Receives: Biological: barzolvolimab
Placebo Comparator in patients with Chronic Inducible Cold UrticariaPlacebo comparatorPlacebo injection subcutaneous every 4 weeks for 20 weeks
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with a negative provocation test at week 12

    Percentage of patients with a negative provocation test for Cold Inducible Urticaria [ColdU] or Symptomatic Dermographism [SD]) at week 12

    • For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®
    • For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®

    Measured: From baseline to week 12

Secondary outcomes (7)

  1. Change in provocation threshold and itch for ColdU

    Mean change from baseline to week 12 in critical temperature threshold (CTT) in patients with ColdU

    CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark

    Measured: From baseline to week 12

  2. Change in provocation threshold for SD

    Mean change from baseline to Week 12 in Critical Friction Threshold (CFT) in patients with SD

    CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark

    Measured: From baseline to week 12

  3. Change in worst itch reported after provocation for ColdU

    Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with ColdU

    Measured: From baseline to week 12

  4. Combined patients with a negative provocation test at week 12

    Percentage of combined patients with a negative TempTest (ColdU) or FricTest (SD) at week 12

    Measured: From baseline to week 12

  5. Change in worst itch reported after provocation for SD

    Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD

    Measured: From baseline to week 12

  6. Change in worst itch reported after provocation in both SD and ColdU

    Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD and ColdU combined

    Measured: From baseline to week 12

  7. Percentage of patients experiencing adverse events

    Percentage of patients experiencing treatment-emergent adverse events (TEAE) examined by ColdU patients, SD patients and in combination. A TEAE is any untoward medical occurrence in a patient administered a study treatment.

    Measured: From baseline to week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2022
  2. Study start28 Jun 2022
  3. Primary completion12 Jun 2024
  4. Study completion12 Sep 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05405660
Sponsor's protocol ID
CDX0159-07
Other IDs
2021-006447-95
Status last verified
Nov 2025
First submitted
1 Jun 2022
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing barzolvolimab in people with Chronic Inducible Urticaria, run by Celldex Therapeutics at 76 sites in 11 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Germany, Poland, South Africa, Bulgaria and 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with a negative provocation test at week 12 (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05405660.

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 6 Nov 2025.

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