Cholinergic Urticaria - Efficacy of Dupilumab — CHED  

Cholinergic Urticaria Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Proof of Concept, Multicenter, 16-week Treatment Study With a 16 Week Follow-up Period to Assess the Efficacy and Safety of Dupilumab (Anti-IL4Ra) in Adult Patients With Cholinergic Urticaria Despite H1-antihistamine Treatment

Status Completed

Clinical Trial Summary

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).

Clinical Trial 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 CholU 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 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 skin reactions.

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 chronic spontaneous urticaria (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. ;

Related Conditions & MeSH terms

• Cholinergic Urticaria
• Urticaria

• NCT number: NCT03749148
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2018
• Completion date: February 28, 2023