Chronic Spontaneous UrticariaPhase 2NCT05368285
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
A Phase 2 study testing barzolvolimab in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 56 sites in 9 countries.
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 Spontaneous Urticaria Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous 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
- 208 participants
- Where
- 56 sitesin 9 countries
- Study dates
- 19 May 2022to 20 Dec 2024
- 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 spontaneous urticaria (CSU) >/= 6 months.
- Diagnosis of CSU 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.
- UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment.
Show all 9Show fewer
- 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.
Who cannot join
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- Active, pruritic skin condition in addition to CSU.
- 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.
Show all 9Show fewer
- History of anaphylaxis
- 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
56 sites in 9 countries.
56 sites in 9 countries
United States13 sites
Kern Research, Inc
Bakersfield, California, 93301
Clinical Research Center of Alabama dba Allervie Clinical Research
Birmingham, Alabama, 35249
Treasure Valley Medical Research
Boise, Idaho, 83706
IMMUNOe Research Centers
Centennial, Colorado, 80112
Institute for Asthma and Allergy
Chevy Chase, Maryland, 20815
Little Rock Allergy & Asthma CRC
Little Rock, Arkansas, 72205
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, 42301
Allergy & Asthma Consultants
Redwood City, California, 94063
Medical Research of Arizona
Scottsdale, Arizona, 85251
Montefiore Medical Center/Subspeciality-Allergy and Immunology
The Bronx, New York, 10461
Chesapeake Clinical Research
White Marsh, Maryland, 21162
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
Germany10 sites
Charite - Institute of Allergology IFA Campus Benjamin Franklin
Berlin, 12203
Universitätsklinikum Dresden
Dresden, Saxony, 1307
Universitätsklinikum Düsseldorf - Dermatologie
Düsseldorf, North Rhine-Westphalia, 40225
Hannover Medical University
Hanover, Lower Saxony, 30625
Universitätsklinikum Heidelberg - Dermatologie
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
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
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 Krasowskie
Lublin, 20-573
Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
Opole, 45-401
Medicome Sp. z o.o.
Oświęcim, 21-600
Medicover Integrated Clinical Services Sp. Z.o.o.
Torun, 87-100
Klinika Ambroziak sp. z o.o.
Warsaw, 02-953
South Africa8 sites
WorthWhile Clinical Trials
Benoni, Gauteng, 1500
Iatros International
Bloemfontein, Free State, 9324
The University of Cape Town - Lung Institute
Cape Town, 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
Bulgaria5 sites
"Diagnostic Consultative Center Pulmed" EOOD
Plovdiv, 4002
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, 4002
Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
Razgrad, 7200
Medical Center Iskar EOOD Office of Clinical Allergology
Sofia, 1504
Medical Center "SYNEXUS SOFIA", EOOD
Sofia, 1784
Hungary4 sites
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
Budapest, 1085
Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
Debrecen, 4032
Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
Szolnok, 5000
Óbudai Egészségügyi Centrum Kft.
Zalaegerszeg, 8900
Spain4 sites
Hospital General Universitario de Alicante
Alicante, 3010
Hospital del Mar
Barcelona, 08003
Hospital Bellvitge
Barcelona, 8907
Universidad de Navarra
Madrid, 28027
Georgia3 sites
Healthy Future
Tbilisi, 0119
Center of Allergy and Immunology
Tbilisi, 0159
Multiprofile Clinic Consilium Medulla
Tbilisi, 0186
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Spontaneous 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 Spontaneous Urticaria
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 Spontaneous Urticaria.
There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- barzolvolimab, Matching Placebo
- Keywords
- CDX-0159, barzolvolimab
- Medical subject headings
- Chronic 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 group | Role | What they receive |
|---|---|---|
| barzolvolimab 75 mg then 150 mg | Experimental | barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks Receives: Biological: barzolvolimab |
| barzolvolimab 75 mg then 300 mg | Experimental | barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks Receives: Biological: barzolvolimab |
| barzolvolimab 150 mg | Experimental | barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks Receives: Biological: barzolvolimab |
| barzolvolimab 300 mg | Experimental | barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks Receives: Biological: barzolvolimab |
| Placebo then barzolvolimab 150 mg | Experimental | Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks Receives: Biological: barzolvolimab; Drug: Matching Placebo |
| Placebo then barzolvolimab 300 mg | Experimental | Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks Receives: Biological: barzolvolimab; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42.
Itch severity score (ISS) is on a scale of 0 - 3.
0 = None
- = mild (present, but not annoying or troublesome)
- = moderate (troublesome, but does not interfere with normal daily activity or sleep)
- = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep)
Hives severity score (HSS) is on a scale of 0 - 3.
0 = None
- = less than 20 hives
- = between 20 and 50 hives
- = greater than 50 hives
Measured: From baseline to Day 85 (Week 12)
Secondary outcomes (3)
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Measured: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Measured: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)
AAS captures the presences of swelling over the last 24 hours and rates the severity with 5 questions. The possible range of the weekly score is 0 - 105.
Measured: From baseline to Day 85 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start19 May 2022
- Primary completion28 Sep 2023
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Spontaneous 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368285
- Sponsor's protocol ID
- CDX0159-06
- Other IDs
- 2021-006413-11
- Status last verified
- Mar 2025
- First submitted
- 5 May 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Metz M, Mitha E, Leflein J, Talreja N, Gotua M, Krasowska D, Peter J, Anderson J, Young D, Heath-Chiozzi M, Paradise E, Greenberg S, Bernstein JA. Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol. 2026 Feb 24:S0091-6749(26)00129-6. doi: 10.1016/j.jaci.2026.02.018. Online ahead of print.
PubMed 41747871
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT05368285
- Acronym / sponsor ID
- CDX0159-06
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- CDX-0159, barzolvolimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 10 May 2022 (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 study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria
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 Spontaneous Urticaria.
There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| barzolvolimab 75 mg then 150 mg | Experimental | Biological: barzolvolimabbarzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks |
| barzolvolimab 75 mg then 300 mg | Experimental | Biological: barzolvolimabbarzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks |
| barzolvolimab 150 mg | Experimental | Biological: barzolvolimabbarzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks |
| barzolvolimab 300 mg | Experimental | Biological: barzolvolimabbarzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks |
| Placebo then barzolvolimab 150 mg | Experimental | Biological: barzolvolimab, Drug: Matching PlaceboPlacebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks |
| Placebo then barzolvolimab 300 mg | Experimental | Biological: barzolvolimab, Drug: Matching PlaceboPlacebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, >/= 18 years of age.
- Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.
- Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- 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.
Key exclusion criteria (9 listed)
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- Active, pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known active 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 | Biological | Placebo then barzolvolimab 150 mg, Placebo then barzolvolimab 300 mg, barzolvolimab 150 mg, barzolvolimab 300 mg, barzolvolimab 75 mg then 150 mg, barzolvolimab 75 mg then 300 mg |
| Matching PlaceboSubcutaneous Administration | Drug | Placebo then barzolvolimab 150 mg, Placebo then barzolvolimab 300 mg |
Primary outcome
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Time frame: From baseline to Day 85 (Week 12)
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None 1. = mild (present, but not annoying or troublesome) 2. = moderate (troublesome, but does not interfere with normal daily activity or sleep) 3. = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep) Hives severity score (HSS) is on a scale of 0 - 3. 0 = None 1. = less than 20 hives 2. = between 20 and 50 hives 3. = greater than 50 hives
3 secondary outcomes
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
Time frame: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
Time frame: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)
Time frame: From baseline to Day 85 (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 41747871Metz M, Mitha E, Leflein J, Talreja N, Gotua M, Krasowska D, Peter J, Anderson J, Young D, Heath-Chiozzi M, Paradise E, Greenberg S, Bernstein JA. Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol. 2026 Feb 24:S0091-6749(26)00129-6. doi: 10.1016/j.jaci.2026.02.018. Online ahead of print.
Related trials for Chronic Spontaneous Urticaria
Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Active, not recruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing barzolvolimab in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 56 sites in 9 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 9 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: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Germany, Poland, South Africa, Bulgaria and 4 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. 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?
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (time frame: From baseline to Day 85 (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 NCT05368285, which also lists 1 linked publication.
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 26 Mar 2025.