Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT04538794
Eligibility Criteria:
Key Inclusion Criteria:
1. Males and females, 18 - 75 years old.
2. Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by:
1. Diagnosis of CSU for \>/= 6 months.
2. The presence of itch and hives for \>/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.
3. UAS7 of \>/= 16 and HSS7 of \>/= 8 during the 7 days before treatment
4. In-clinic UAS \>/= 4 on one of the screening visit days
5. Use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study.
3. Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
6. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Key Exclusion Criteria:
1. Women who are pregnant or nursing.
2. Cleary defined cause for chronic urticaria.
3. Known HIV, hepatitis B or hepatitis C infection.
4. Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection.
5. History of anaphylaxis.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04538794
Study Brief:
Protocol Section:
NCT04538794