A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Purpose

The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.

Conditions

  • Chronic Inducible Urticaria
  • Cold Urticaria
  • Cold-Induced Urticaria
  • Symptomatic Dermographism

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males and females, >/= 18 years of age. 2. Diagnosis of cold induced urticaria or symptomatic dermographism >/= 3 months. 3. Diagnosis of cold induced urticaria or symptomatic dermographism 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 H1-antihistamines. 2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment. 3. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and < 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening 5. Normal blood counts and liver function tests. 6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment. 7. Willing and able to complete a daily symptom electronic diary and comply with study visits. 8. Participants with and without prior biologic experience are eligible.

Exclusion Criteria

  1. Women who are pregnant or nursing. 2. Clearly defined cause for chronic urticaria. 3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism. 4. Medical condition that would cause additional risk or interfere with study procedures. 5. Known HIV, hepatitis B or hepatitis C infection. 6. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. 7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water). 8. 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
barzolvolimab in patients with Cold Induced Urticaria 		barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
  • Drug: Barzolvolimab
    Subcutaneous Administration
    Other names:
    • CDX-0159
Placebo Comparator
Placebo in patients with Cold Induced Urticaria 		Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
  • Drug: Matching Placebo
    Subcutaneous Administration
Experimental
barzolvolimab in patients with Symptomatic Dermographism 		barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
  • Drug: Barzolvolimab
    Subcutaneous Administration
    Other names:
    • CDX-0159
Placebo Comparator
Placebo in patients with Symptomatic Dermographism 		Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
  • Drug: Matching Placebo
    Subcutaneous Administration

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Celldex Therapeutics

Study Contact

Celldex Therapeutics
844-723-9363
clinicaltrials@celldex.com

Detailed Description

The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced 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 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg every 4 weeks. Then there is a 28-week treatment period where all patients will receive 300mg barzolvolimab every 8 weeks, followed by a 16-week follow-up period where all patients are observed.