Dupilumab in Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria; Recurrent Angioedema
MeSH terms: Angioedema; Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy in reducing disease activity and safety
      of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic
      despite H1-antihistamine treatment.
    

Detailed description: 
      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
      European Medicines Agency (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 CSU and atopic diseases share many common features
      (e.g. key pathogenic role of mast cells and immunoglobulin E (IgE), itch is a dominant
      symptom, Th2 dominance), it is reasonable to expect that Dupilumab is beneficial in CSU.

      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
      skin reactions.

      The gold standard treatment of CSU consists of administration of antihistamines. In more than
      50% of the patients, symptoms persist with standard dosing of antihistamines. In
      antihistamine-refractory patients with chronic spontaneous urticaria, the currently only
      licensed treatment is omalizumab, a monoclonal anti-IgE antibody. In 2014, omalizumab has
      been licensed for add-on therapy in CSU patients who still have symptoms despite
      standard-dosed antihistamine treatment. There is, however, still a great medical need for
      additional treatment options, as 20-40% of patients are still without effective therapy.
      These patients have no other licensed treatment option and can only be treated off-label with
      therapeutics with several known safety risks such as Cyclosporine A.

      Dupilumab has excellent potential to provide symptom control in CSU. 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 CSU symptoms.
    

Intervention name(s): Dupilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): anti-IL4-Receptor alpha; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase 2a multicenter, randomized, double blind, placebo controlled, parallel group, two-arm, proof-of-concept investigator-initiated trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hives; itch