* Study of efficacy and safety of ligelizumab in chronic spontaneous urticaria patients

• Research type

  Research Study

• Full title

  A multi-center, double-blinded and open-label extension study to evaluate the efficacy and safety of ligelizumab as retreatment, self-administered therapy and monotherapy in Chronic Spontaneous Urticaria patients who completed studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

• IRAS ID

  1003678

• Contact name

  Sebastiano Corridore

• Contact email

  sebastiano.corridore@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2019-001792-37

• Clinicaltrials.gov Identifier

  NCT04210843

• Research summary

  The study is an extension study for Chronic Spontaneous Urticaria (CSU) patients who have completed the CQGE031C2303 (pearl 2) study in the UK. Previous studies have shown that ligelizumab can improve itch and hives in subjects with CSU who have failed treatment H1-antihistamines. This study will further establish safety and efficacy of ligelizumab (QGE031) 120 mg sub cutaneously (sc) every 4 weeks (q4w). This study will allow patients treated in the pearl 2 study to continue to have access to ligelizumab.
  The study will look at how self-administration works outside the clinic setting and evaluate if treatment for a longer time with ligelizumab results in improvement or recovery of the disease. There are up to two observational periods in the study which patients will enter as long as their symptoms are not moderate to severe. During the observational periods patients will not receive any investigational treatment. If symptoms become moderate or severe patients will be treated with ligelizumab every four weeks. Approximately 307 adult CSU patients have been treated with this medicine in completed clinical trials to date. 1800 people will take part in the study and participation will last up to 208 weeks (4 years). The study will involve a maximum of 52 visits over the 4 years. Patients will be expected to complete an electronic diary twice a day during the study to record disease symptoms and rescue medication usage.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/FT/0107

• Date of REC Opinion

  7 Oct 2021

• REC opinion

  Further Information Favourable Opinion