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Compares treatment options for Chronic Inducible Urticaria
Official title 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)
ClinicalTrials.gov ID: NCT07266402
What this study is testing
What is Barzolvolimab?
Barzolvolimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic inducible urticaria.
Also referred to as CDX-0159.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males and females, \>/= 18 years of age.
- Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months.
- Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating...
- 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.
You likely can't join if
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known HIV, hepatitis B or hepatitis C infection.
- Vaccination with a live vaccine within 30 days prior to screening (people must agree to avoid vaccination with a live vaccine during the study)...
See the full eligibility criteria
- Males and females, \>/= 18 years of age.
- Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months.
- 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:
- 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.
- 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.
- 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.
- Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
- 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.
- Participants with and without prior biologic experience are eligible. Key
- Women who are pregnant or nursing.
- Clearly defined cause for chronic urticaria.
- Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known HIV, hepatitis B or hepatitis C infection.
- Vaccination with a live vaccine within 30 days prior to screening (people must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or...
- History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).
- Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Bakersfield, California, United States
- Napa, California, United States
- Redwood City, California, United States
- Sherman Oaks, California, United States
- Ventura, California, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Columbus, Georgia, United States
- Boise, Idaho, United States
- Skokie, Illinois, United States
- Bowling Green, Kentucky, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Troy, Michigan, United States
- New York, New York, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Bakersfield, California, United States; Napa, California, United States; Redwood City, California, United States; Sherman Oaks, California, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.