Cold Urticaria
Conditions
Interventions
Drug: Dupilumab SAR231893
Pharmaceutical form:Injection solution, Route of administration: Subcutaneous
Drug: Placebo
Pharmaceutical form:Injection solution, Route of administration: Subcutaneous
Dr
Sponsors
Tanaka Tomoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be >=12 years to 80 years of age inclusive at the time of signing the informed consent - Participants who have a diagnosis of primary acquired chronic inducible ColdU defined as recurrence of itchy wheals and/or angioedema due to cold for longer than 6 weeks prior to screening visit (Visit 1) - Participants with positive ice cube provocation test, ie, presenting at least a confluent hive/wheal on the exposed skin area, at the screening visit (Visit 1) and randomization visit (Visit 2) - Participants meeting at least 1 of the following criteria despite regular/daily or as needed use of H1-AH: - - Urticaria Control Test (UCT) (4 item) = 30 kg
Exclusion criteria
Exclusion criteria: Participants are excluded from any of the studies if any of the following criteria apply: - Clearly defined underlying etiology for urticaria other than primary acquired chronic inducible ColdU - Presence of skin morbidities other than cold urticaria that may interfere with the assessment of the study outcomes - Active atopic dermatitis - Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study - Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated." - Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period - Known or suspected immunodeficiency - Active malignancy or history of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin - History of systemic hypersensitivity or anaphylaxis to any other biologic therapy, or any of its excipients - Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with negative ice cube provocation test at Week 24 compared with placebo [Time frame: Week 24] Negative ice cube provocation test is defined as the absence of a confluent hives/wheal at the entire skin site of exposure after ice cube provocation test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in urticaria control test at Week 24 compared with placebo [Time Frame: Baseline to Week 24] The UCT is a PRO questionnaire for assessing urticaria control. It is comprised of 4 items (UCT-4). The UCT-4 total score is 0-16, with a score of 16 for complete disease control. 2. Proportion of well-controlled participants at Week 24 compared with placebo [Time Frame: Week 24] The UCT is a PRO questionnaire for assessing urticaria control. It is comprised of 4 items (UCT-4). The UCT-4 total score is 0-16, with a score of 16 for complete disease control. Well-controlled is UCT-4 total score >=12. 3. Proportion of participants with an improvement of >=3 in UCT-4 item from baseline to Week 24 compared with placebo [Time Frame: Baseline to Week 24] The UCT is a PRO questionnaire for assessing urticaria control. It is comprised of 4 items (UCT-4). The UCT-4 total score is 0-16, with a score of 16 for complete disease control. 4. Change from baseline in local wheal intensity at the provocation site at Week 12 and 24 using the wheal intensity Likert scale compared with placebo [Time Frame: Baseline to Week 12 and Week 24] The Wheal intensity Likert scale (ranging from 0 to 5) is a clinician-reported outcome measure comprised of a single item assessing the intensity of patients' cutaneous reaction rated as follows: 0=no wheals; 1=numerous small, noncoalescent wheals; 2= a large, regular, slightly edematous, coalescent wheal; 3=a large and moderately edematous wheal; 4=a large, regular, and significantly edematous wheal without pseudopodia; and 5=a large, very edematous wheal with pseudopodia. 5. Change from baseline in local itch severity at the provocation site at Week 12 and 24 using the Peak Pruritus Numerical Rating Scale (NRS) compared with placebo [Time Frame: Baseline to Week 12 and Week 24] The peak pruritus NRS is a patient-reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst itch imaginable"). 6 | — |
Countries
Argentina, Canada, Germany, Japan, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed