Active not recruitingPHASE3INTERVENTIONAL

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

This research is testing a new medicine, barzolvolimab, for adults who have chronic spontaneous urticaria (CSU), also known as chronic hives. These are hives that appear without a clear cause and haven't gotten better with standard antihistamines. The main goal is to see if barzolvolimab is effective at reducing hives and itching, if it's safe to use, and if people can tolerate its side effects, compared to a placebo (a dummy medicine). Participants will receive either barzolvolimab or a placebo for part of the study, and then everyone will receive the active medicine. The study involves regular check-ups and keeping track of symptoms. It aims to help find better treatments for chronic hives.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Celldex Therapeutics

Enrolment target

963

Start

11 Jul 2024

Estimated completion

01 Apr 2027

Chronic Spontaneous Urticaria

What is this study about?

This clinical trial is designed to investigate a new potential treatment for a condition called Chronic Spontaneous Urticaria (CSU). CSU is a type of chronic hives where red, itchy welts (hives) appear on the skin for more than six weeks without an obvious cause. For many people, these hives can be very bothersome and significantly impact their daily lives, even when they take antihistamines, which are the usual first-line treatment.

The new medicine being tested is called barzolvolimab. Researchers want to find out if this medicine can effectively reduce the symptoms of CSU, like itching and the appearance of hives, better than a placebo (a treatment that looks like the medicine but contains no active drug). They also want to carefully observe if the medicine is safe to use and if people experience any side effects. This is a "Phase 3" study, which means it's one of the final steps before a new medicine might be considered for wider use, if proven successful.

Taking part in such a study is important because it helps scientists understand new medicines better. The information gathered can potentially lead to new and more effective treatment options for people living with chronic hives, offering them relief when current treatments aren't enough. Your participation, if you're eligible, could contribute to medical progress that helps many others.

Key takeaways

It's a study for adults with chronic hives not controlled by antihistamines.
The new medicine being tested is called barzolvolimab.
You might receive the active medicine or a dummy medicine (placebo) initially.
The study lasts about 18 months and involves regular clinic visits.
Participation helps find new treatments for chronic hives.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have had chronic spontaneous urticaria (hives) for at least six months. Your hives should still be a problem even though you're regularly taking non-drowsy antihistamines (up to four times the usual dose).

Important symptoms you should have include a certain level of itchiness and hives, which will be measured using special scores. You'll also need to be generally healthy, with normal blood test results for things like blood counts and liver function. If you could become pregnant, you'll need to agree to use effective birth control during and for several months after the study.

There are also some reasons you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have other skin conditions that cause itching. You also can't have certain infections like HIV or hepatitis B/C, a history of severe allergic reactions (anaphylaxis), or have already received the study medicine, barzolvolimab. Your study doctor will go through all the detailed criteria with you to make sure it's safe and appropriate for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had chronic hives for at least 6 months?
Are your hives still bothering you even though you take non-drowsy antihistamines regularly?
Are you able to use reliable birth control if you could become pregnant?
Can you keep a daily symptom diary and attend all study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will involve several stages over a long period. First, there's a screening period of up to 4 weeks to check if you're suitable. After that, you'll enter the main treatment phase.

For the first 24 weeks, you will be randomly assigned to receive either the active medicine (barzolvolimab) or a placebo (a dummy medicine). Neither you nor your study doctor will know which one you are getting. Following this, everyone in the study will receive barzolvolimab for another 28 weeks. After all treatment periods, there will be a 16-week follow-up period where you won't take any study medicine.

Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to assess your symptoms. You will also need to complete an electronic diary daily to track your symptoms. The entire study participation, from start to finish, will last for about 18 months.

Potential risks and benefits

Participating in this study might offer you a potential benefit if you receive the active medicine and it helps to reduce your chronic hives and itching, especially if current treatments haven't worked for you. However, there's no guarantee that you will receive the active medicine or that it will be effective. As with any medicine, there's a risk of side effects from barzolvolimab. These potential risks will be explained to you in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (235)

Cahaba Dermatology Skin Health Center
Verified postcode
Birmingham, United States
First OC Dermatology - Fountain Valley
Verified postcode
Fountain Valley, United States
310 Clinical Research
Verified postcode
Inglewood, United States
Dermatology Research Associates
Verified postcode
Los Angeles, United States
Focus Clinical Research - Los Angeles
Verified postcode
Los Angeles, United States
Cura Clinical Research
Verified postcode
Oxnard, United States
Allergy and Asthma Consultants
Verified postcode
Redwood City, United States
Acclaim Clinical Research
Verified postcode
San Diego, United States
West Dermatology Research Center
Verified postcode
San Diego, United States
Therapeutics Clinical Research
Verified postcode
San Diego, United States
Orso Health, Inc.
Verified postcode
Torrance, United States
Integrated Research of Inland, Inc.
Verified postcode
Upland, United States

Common questions

What is Chronic Spontaneous Urticaria (CSU)?

CSU is a type of chronic hives that appear on your skin for more than six weeks without a clear cause, often causing itchiness.

What is barzolvolimab?

Barzolvolimab is a new medicine being tested to see if it can help improve symptoms for people with chronic spontaneous hives.

Will I know if I'm getting the real medicine or a placebo?

For the first part of the study, neither you nor your doctor will know if you're receiving the active medicine or a placebo. This is to ensure the study results are unbiased.

How long will I be in the study?

If you join, your participation will last for approximately 18 months in total, including screening, treatment, and follow-up periods.

What if my hives get worse during the study?

Your study doctor will monitor your condition closely throughout the trial. You can discuss any concerns or changes in your health with them at any time.