A Study to Evaluate the Safety and Effectiveness of Ligelizumab to Treat Chronic Spontaneous Urticaria Patients

Overview

About this study

The purpose of this study is to establish effectiveness and safety of ligelizumab. This will be assessed in patients with chronic spontaneous urticaria (CSU) who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. For this curreent study only adults will be enrolled, as no adolescents were enrolled in the previous study (CQGE031C2303).  In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.  This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Written informed consent.
  • Subjects who successfully completed all of the treatment period and the follow-up  period in any of the following studies:
    • CQGE031C2302, CQGE031C2303, CQGE031C2202 or  CQGE031C1301.
  • Male and female, ages ≥ 18 years of age.
  • Willing and able to complete a daily symptom eDiary for the duration of the study and  adhere to the study visit schedule.

Exclusion Criteria:

  • Use of investigational drugs, other than those in use in the preceding studies, at the  time of enrollment.
  • Use of omalizumab within 16 weeks of Screening.
  • History of hypersensitivity to the study drug ligelizumab or its components, or to  drugs of similar chemical classes.
  • New onset or signs and symptoms of any form of chronic urticarias other than CSU  during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.  
  • Diseases with possible symptoms of urticaria or angioedema.
  • Subjects with evidence of helminthic parasitic infection.
  • Documented history of anaphylaxis.
  • Pregnant or nursing (lactating) women.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gerald Volcheck, M.D.

Open for enrollment

Contact information:

Kay Bachman R.N., C.C.R.C.

(507) 284-5689

bachman.kay@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20489835

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