Overview
Chronic spontaneous urticaria (CSU), also known as chronic hives, is a condition that causes itchy, raised welts on the skin that can appear without warning. Some people may also experience swelling in areas such as the face, lips, hands, or feet. Symptoms may come and go and can last for weeks, months, or longer.
Living with CSU can affect many parts of daily life. Itching, discomfort, and sudden flare-ups may make it harder to sleep, focus on work or school, enjoy social activities, or feel comfortable throughout the day. Many people living with CSU continue searching for ways to better manage their symptoms.
Join Our Chronic Hives Research Study of THB335 for Treating the Symptoms of Chronic Spontaneous Urticaria (CSU).
The INHIBIT-CSU Study is enrolling adults in a clinical research study to learn more about chronic spontaneous urticaria and to evaluate an investigational drug.
About the Study
The INHIBIT-CSU Study is a Phase 2 clinical trial evaluating the effectiveness and safety of an oral investigational medication (THB335) for adults with chronic spontaneous urticaria (CSU) who continue to have symptoms continue despite use of standard-of-care treatment.
This medication offers a needle-free, convenient alternative to traditional injections.
Participation in a clinical research study is voluntary. Before joining, the study team will explain the purpose of the study, what participation may involve, possible risks and benefits, and answer any questions you may have.
Who Can Join
You may be eligible to participate if you:
- Are 18 to 85 years of age
- Have been diagnosed with chronic spontaneous urticaria (CSU) at least 6 months
- Have been experiencing active itching and hives for at least 6 weeks
- Continue to struggle with itchiness and hives despite using treatments
- Have a BMI of 18-38
Meet additional study criteria
Study-related care and the investigational drug may be provided to eligible study participants at no cost. In addition, travel for study-related visits may be provided for study participants.
What to Expect
If you qualify and choose to participate, you may be asked to:
- Attend study visits with the research team
- Answer questions about your health and symptoms
- Receive study-related evaluations and procedures
- Follow study instructions provided by the site staff
During the study, you will:
- Receive study-related care and medication at no cost.
- Get help with travel expenses or reimbursement for your visits.
- Receive regular health check-ups while helping to advance CSU research.
A study representative will reach out to discuss the study with you. If you qualify for the INHIBIT CSU Study, there will be no cost to participate.
Study Duration
The study will last about 20 weeks (just over 5 months) and will include around 10 study visits for care and health monitoring. It will include a screening period, a placebo-controlled treatment period, and a safety follow-up period.
- Screening Phase (up to 4 weeks): You will keep a diary of your symptoms (such as hives and itching) for at least 14 days and complete screening tests, including lab work, to confirm eligibility.
- Treatment Phase (about 12 weeks): Participants will be randomly assigned to receive either the investigational medication or placebo (looks the same as the study drug but contains no active treatment). Neither you nor the study team will know which treatment you are receiving to allow for an unbiased evaluation of outcomes.
- Follow-Up Phase (about 4 weeks): You will return for follow-up visits where the study team will check your health, monitor symptoms, and assess safety and effectiveness.
More details will be provided to you by the study team, and you will have a chance to ask questions before making an informed decision about whether you wish to join the clinical trial.
Participation is voluntary and you can leave the study at any time for any reason.
