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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06455202




Registration number
NCT06455202
Ethics application status
Date submitted
7/06/2024
Date registered
12/06/2024
Date last updated
27/12/2024

Titles & IDs
Public title
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
Secondary ID [1] 0 0
2024-513210-36-00
Secondary ID [2] 0 0
CDX0159-13
Universal Trial Number (UTN)
Trial acronym
EMBARQ-CSU2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - barzolvolimab
Treatment: Other - Matching placebo

Experimental: barzolvolimab 150 mg - barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks

Experimental: barzolvolimab 300 mg - barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks

Experimental: Placebo then barzolvolimab 150 mg - Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.

Experimental: Placebo then barzolvolimab 300 mg - Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.


Treatment: Other: barzolvolimab
Subcutaneous Administration

Treatment: Other: Matching placebo
Matching placebo Subcutaneous Administration
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Timepoint [1] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [1] 0 0
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
Timepoint [1] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [2] 0 0
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
Timepoint [2] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [3] 0 0
Percentage of patients with UAS7=0 at Week 12
Timepoint [3] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [4] 0 0
Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12
Timepoint [4] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [5] 0 0
Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12
Timepoint [5] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [6] 0 0
Percentage of participants with UAS7 = 6 at Week 12
Timepoint [6] 0 0
From Day 1 (first dose) to Day 85 (Week 12)
Secondary outcome [7] 0 0
Mean change from baseline in UAS7 at Week 4
Timepoint [7] 0 0
From Day 1 (first dose) to Day 29 (Week 4)
Secondary outcome [8] 0 0
Mean change from baseline in UAS7 at Week 24
Timepoint [8] 0 0
From Day 1 (first dose) to Day 169 (Week 24)
Secondary outcome [9] 0 0
Percentage of participants with UAS7 = 0 at Week 24
Timepoint [9] 0 0
From Day 1 (first dose) to Day 169 (Week 24)
Secondary outcome [10] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [10] 0 0
From Day 1 (first dose) to Day 477 (Week 68)

Eligibility
Key inclusion criteria
Key

1. Males and females, >/= 18 years of age.
2. Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.
3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

1. The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
3. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
7. Participants with and without prior biologic experience are eligible.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or nursing.
2. Chronic inducible urticaria that would confound the study endpoints.
3. Other diseases associated with urticaria.
4. Active pruritic skin condition in addition to CSU.
5. Medical condition that would cause additional risk or interfere with study procedures.
6. Known HIV, hepatitis B or hepatitis C infection.
7. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
8. History of anaphylaxis
9. Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
915
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QS
Recruitment hospital [1] 0 0
Novatrials - Kotara
Recruitment hospital [2] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment postcode(s) [1] 0 0
2289 - Kotara
Recruitment postcode(s) [2] 0 0
4151 - Coorparoo
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celldex Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Trial website
https://clinicaltrials.gov/study/NCT06455202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Celldex Therapeutics
Address 0 0
Country 0 0
Phone 0 0
844-723-9363
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06455202