Cold Contact Urticaria Treatment With Rilonacept (Cures)
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|ClinicalTrials.gov Identifier: NCT02171416|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : July 17, 2018
Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Typically, symptoms occur within minutes after cold contact, including exposure to cold air, liquids or objects and are limited to cold exposed skin areas.
The investigators postulate that there is an overlap between acquired cold urticaria and cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to antihistamines will benefit from IL-1 targeting treatment strategies.
This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept in patients with cold contact urticaria who could not be successfully treated with first-line medication such as antihistamines.
This is a double-blind placebo-controlled parallel group phase II study of the efficacy and safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the Urticaria specialty clinics of ACC. The total duration of the study course for each patient is 14 weeks and is divided in:
- Screening period (2 weeks, days -14-0)
- Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42)
- Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and will receive the respective dose subcutaneously. Following the placebo-controlled double-blind phase patients will enter the open-label phase and receive rilonacept open-label treatment (160mg or 320mg depending on treatment response during part A).
|Condition or disease||Intervention/treatment||Phase|
|Cold Contact Urticaria||Drug: Rilonacept Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Single-center, Double-blind Placebo-controlled Parallel Group Phase II Study of the Efficacy and Safety of Rilonacept in Subjects With Cold Contact Urticaria (CCU)|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||May 2018|
Placebo Comparator: Placebo
Placebo s.c every 7 days
Other Name: Arcalyst
Experimental: Rilonacept 160mg
Rilonacept s.c every 7 days
- To assess the effect of rilonacept on the clinical signs and symptoms of CCU [ Time Frame: 6 weeks ]Change in symptom development (critical temperature thresholds (CTT) in CCU patients from baseline to day 42 in the rilonacept group as compared to the placebo group
- To assess the safety of rilonacept in subjects with CCU [ Time Frame: 6 weeks ]This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
- Change in the patient's quality of life [ Time Frame: 6 weeks ]Assessed by the Dermatology Life Quality Index (DLQI) from baseline to day 42 in the rilonacept group as compared to the placebo group and from baseline to the open-label treatment with rilonacept
- Differences in mast cell mediator release [ Time Frame: 6 weeks ]Measured in the blood of CCU patients during the challenge with cold water at day 42 in the rilonacept group as compared to the placebo group and during the open-label treatment in the rilonacept 160 mg group as compared to the 320 mg group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171416
|University Berlin Charité ; Dermatology|
|Berlin, Germany, 10117|
|Mainz, Germany, 55131|
|Principal Investigator:||Karoline Krause, MD||Charite University, Berlin, Germany|