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

Chronic Spontaneous Urticaria Clinical Trial

— EMBARQ-CSU2  

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455202
• Other study ID #: CDX0159-13
• Secondary ID: 2024-513210-36-0
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2024
• Est. completion date: April 2027

Study information

• Verified date: June 2024
• Source: Celldex Therapeutics
• Contact: Celldex Therapeutics
• Phone: 844-723-9363
• Email: clinicaltrials[@]celldex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 915
• Est. completion date: April 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Biological:
• barzolvolimab
Subcutaneous Administration
• Matching placebo
Matching placebo Subcutaneous Administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).; The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)	The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21.	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)	The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21.	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Percentage of patients with UAS7=0 at Week 12	Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12	Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab.; The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12	Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab.	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Percentage of participants with UAS7 = 6 at Week 12	Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7	From Day 1 (first dose) to Day 85 (Week 12)
Secondary	Mean change from baseline in UAS7 at Week 4	Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).; The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.	From Day 1 (first dose) to Day 29 (Week 4)
Secondary	Mean change from baseline in UAS7 at Week 24	Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).; The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.	From Day 1 (first dose) to Day 169 (Week 24)
Secondary	Percentage of participants with UAS7 = 0 at Week 24	Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.	From Day 1 (first dose) to Day 169 (Week 24)
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurrence of treatment emergent adverse events and serious adverse events during the study.	From Day 1 (first dose) to Day 477 (Week 68)