The purpose of this study is to assess the efficacy in reducing disease activity and safety
of Dupilumab in adult patients with cholinergic urticarial (CholU) who are symptomatic
despite H1-antihistamine treatment (licensed dose).
Treatment with Dupilumab has been shown to reduce clinically significant exacerbations and to
improve skin symptom control as well as quality of life in moderate to severe atopic
dermatitis patients and in moderate to severe asthma patients. It has been approval by EMA
for the treatment of atopic dermatitis patients in September 2017.
Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 (IL-4) and
interleukin-13 (IL-13) signaling and was previously found to be effective in atopic
dermatitis and asthma. Considering that CholU and atopic diseases share many common features
(e.g. key pathogenic role of mast cells and IgE, itch is a dominant symptom, Th2 dominance),
it is reasonable to expect that Dupilumab is beneficial in CholU.
These results suggest that Dupilumab may provide an effective treatment option for patients
with insufficient treatment responses to H1-antihistamines exhibiting wheal and flare type
The gold standard treatment of CholU consists of administration of antihistamines. In most
patients, symptoms persist with standard dosing of antihistamines. In
antihistamine-refractory patients with cholinergic urticaria, no other licensed treatment is
currently available. In 2014, omalizumab has been licensed for add-on therapy in CSU patients
who still have symptoms despite standard-dosed antihistamine treatment, but not for chronic
inducible forms of urticaria. Accordingly, there is still a great medical need for additional
treatment options of CholU patients that are refractory to antihistamine treatment.
Dupilumab has excellent potential to provide symptom control in CholU. This study will
provide additional valuable insights into the therapeutic potential of Dupilumab in improving
quality of life in these patients, in addition to managing CholU symptoms.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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