Dupilumab for the treatment of Chronic Spontaneous Urticaria

• Research type

  Research Study

• Full title

  Master protocol of two randomized, double-blind, placebo controlled, multi center, parallel-group studies of dupilumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment in patients naïve to omalizumab and in patients who are intolerant or incomplete responders to omalizumab

• IRAS ID

  279777

• Contact name

  Anthony Bewley

• Contact email

  anthony.bewley@nhs.net

• Sponsor organisation

  Sanofi-Aventis Recherche & Développement

• Eudract number

  2019-003775-19

• Clinicaltrials.gov Identifier

  NCT04180488

• Clinicaltrials.gov Identifier

  NIHR CRN, DERM 42754

• Duration of Study in the UK

  1 years, 0 months, 9 days

• Research summary

  Summary of Research
  The purpose of this study is to test, in people aged 12-80 with chronic spontaneous urticaria, how effective dupilumab is and how safe it is in reducing the signs and symptoms in patients with chronic spontaneous urticaria who continue to have symptoms despite the use of H1-antihistamines.

  The duration of the Study is approximately 9 months (38 weeks) and comprises 3 periods:
  • A 2-4 week screening period
  • A 24-week treatment period
  • A follow up period lasting approximately 12 weeks following completion of treatment

  For the conduct of the study, in addition to access and use of the pts medical records, the study staff will also need to collect biological samples (blood and urine) from the pt to perform tests and procedures.
  These samples will be collected to assess if they qualify for study entry, to monitor for potential safety concerns related to the drug, to monitor drug level, and to monitor how the body reacts to the study drug.
  Patients wil also be asked to complete a daily dairy and also complete Questionnaires during site visits.

  Summary of Results
  In this study, researchers wanted to find out if dupilumab was more effective than placebo at improving CSU signs and symptoms (itch and skin bumps) in people who still had symptoms after taking standard antihistamine treatment.
  In Study A and Study C, researchers tested dupilumab in people who had not previously received a CSU medicine called omalizumab, and in Study B, in people who had previously received omalizumab but did not see enough improvement or had to stop it due to side effects In Study A and Study C, researchers found that dupilumab was more effective than placebo at reducing CSU signs and symptoms (itch and skin bumps). In Study B, people taking dupilumab also showed some improvement in CSU signs and symptoms but the difference with placebo was not large enough to be sure it was not due to chance. More research is needed to confirm this finding. In Study A, Study B, and Study C, there were no unexpected safety problems.
  

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  20/LO/0828

• Date of REC Opinion

  9 Jul 2020

• REC opinion

  Further Information Favourable Opinion