This clinical trial is researching a potential study medicine for chronic urticaria (or chronic hives). The study will test a new investigational medication to learn if it can help reduce chronic urticaria symptoms.
Study participants may be able to join the study if they meet the following requirements:
At least 18 years of age or older
Diagnosed with chronic inducible urticaria at least 3 months ago, or with chronic spontaneous urticaria at least 6 months ago
Still experiencing symptoms (such as hives) even after taking antihistamines
Other study requirements will apply.
Participation in this study lasts about 4-5 months : 2 weeks of screening, 3 months of taking the study medicine, and at least 1 month of follow-up. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason. Compensation may be available for participating in this study, additional information will be provided by the site.
Chronic urticaria is a condition that involves cells just under the surface of the skin called mast cells. When mast cells become overactive, they release chemicals, including histamine, which causes outbreaks of hives that can be itchy, swollen, or painful.
There are 2 types of chronic urticaria being researched in this study:
• Chronic inducible urticaria – hives with a known cause or trigger (for example, cold, stress, or friction)
• Chronic spontaneous urticaria – hives without a known cause or trigger
Although options are available to treat chronic urticaria, sometimes symptoms do not go away even after treatment. Researchers are trying to find other options that may help.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Phase 1: First study of the medicine in people (often healthy volunteers)
Phase 2 (this study): Study of the medicine in people with the condition the medicine is for
Phase 3: Study confirming how well the medicine works
Phase 4: More research after the medicine is approved
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
Use the filters, map, and listing to find the study clinic closest to you.