A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) (EMBARQ-CSU2)

Celldex Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Chronic Spontaneous Urticaria

Treatments: Biological: Matching placebo; Biological: barzolvolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06455202

2024-513210-36-00 (EU Trial (CTIS) Number)

CDX0159-13

Details and patient eligibility

About

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.

Full description

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.

There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.

Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

Enrollment: 915 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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915 participants in 4 patient groups

barzolvolimab 150 mg

Experimental group

Description:

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

Treatment:

Biological: barzolvolimab

barzolvolimab 300 mg

Experimental group

Description:

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

Treatment:

Biological: barzolvolimab

Placebo then barzolvolimab 150 mg

Experimental group

Description:

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.

Treatment:

Biological: barzolvolimab

Biological: Matching placebo

Placebo then barzolvolimab 300 mg

Experimental group

Description:

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:

Biological: barzolvolimab

Biological: Matching placebo