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:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT06072157
Eligibility Criteria:
Key Inclusion Criteria:
To be included in the study, the participant must:
* Weigh between 60 and 120 kg (inclusive) and have a body mass index (BMI) between 20 and 32 kg/m2, inclusive
* Agree (female of childbearing potential or male with female partner of childbearing potential) to use a highly effective method (\<1% failure rate) of birth control, if sexually active from screening and for 16 weeks after the last dose of investigational product (IP).
Additionally, to be included in Part A, B and D, the participant must:
• Be in good general health with no significant medical history and has no clinically significant abnormalities on physical examination
Additionally, to be included in Part C, the participant must:
* Have a diagnosis of chronic spontaneous urticaria (CSU) for at least 6 months prior to screening
* Has a diagnosis of moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-AH between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following:
* Presence of hives and itch for ≥6 consecutive weeks at any time prior to the Screening, despite the use of non-sedating H1-AHs. Note: Subject must be on a non-sedating H1-AH for treatment of CSU symptoms at the time of the Screening visit.
* UAS7 score ≥16 with a HSS7 score ≥8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-AH.
* Be on a stable dose of a single 2nd or later generation H1-antihistamines for the treatment of CSU, between 1× and 4× the licensed dose and frequency, by Day -14 of the Screening Period and must be willing to remain on the same stable dose throughout the study.
* Able and willing to complete a daily electronic diary to collect CSU symptoms for the duration of the study.
Key Exclusion Criteria:
A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
* Female participants who are pregnant, lactating, or planning to become pregnant during the study.
* Abnormal laboratory values, or findings in physical examination, ECG (QTc \>450 ms for males and \>470 ms for females), or vital signs considered to be clinically significant by the investigator.
Additionally, a participant will be excluded from Part A, B and D, if:
• Received treatment with any prescribed (excluding hormonal contraceptives or hormone replacement therapy \[post-menopausal females\]) or nonprescribed systemic or topical medication (including herbal product, and vitamins) within 21 days prior to the first dose of IP (excluding acetaminophen).
Additionally, a participant will be excluded from Part C, if:
* Has known or suspected urticarial vasculitis
* Subject has causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria
* Subject has other conditions or diseases that in the investigator's opinion might influence study evaluations and results
* Has any disease or condition (medical or surgical) which, in the opinion of the investigator, or medical monitor, would place the subject at increased risk
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06072157
Study Brief:
Protocol Section:
NCT06072157