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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT07181369
Eligibility Criteria:
Key inclusion Criteria (Part A):
* The subject is between 18 and 55 years of age (both inclusive) at the date of screening.
* The subject is in good general health based on the medical history, physical examination and the results of vital signs, electrocardiogram and clinical laboratory, as judged by the investigator.
Key inclusion Criteria (Part B):
* The subject is between 18 and 75 years of age (both inclusive) at the date of screening
* A history of signs and/or symptoms of ColdU experienced ≥ 3 months prior to screening.
* A positive cold stimulation test during screening and baseline, using the TempTest® device.
* Inadequate control of ColdU by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following cold contact within the last 6 weeks prior to screening in spite of use of a sgAH.
* A Urticaria Control Test (UCT) score of \< 12 at screening.
Key exclusion Criteria (Parts A \& B):
* Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder that would interfere with the patient's safety or the interpretation of trial results in the judgment of the investigator.
* Treatment with an investigational drug or intervention for any condition within three months of screening, or concurrent participation in another clinical trial in which an investigational drug is administered.
* Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus, mycophenolate mofetil, hydroxychloroquine, infliximab, adalimumab, etanercept, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
* Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
* History of immunoglobulin E (IgE)-mediated anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring the use of inhaled medication within the past 5 years.
Additionally for Part B:
* Disease with symptoms of urticaria or angioedema other than Chronic Urticaria (CU), for example urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria. Patients with concomitant Chronic Spontaneous Urticaria (CSU) or other forms of Chronic Inducible Urticaria (CIndU) are eligible provided that symptoms at screening are consistent with ColdU and that ColdU is the dominant form of CU.
* Any other skin disease associated with chronic itching that might influence in the investigators' opinion of the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or psoriasis.
* Receipt of any biologic therapy for urticaria control (e.g. omalizumab, dupilumab, ligelizumab, etc.) within three months of screening (whether on-label or off-label).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07181369
Study Brief:
Protocol Section:
NCT07181369