Giant Cell Arteritis: Efficacy and Safety of Secukinumab

Summary

The purpose of this study is to demonstrate the effectiveness and safety of an investigational drug called secukinumab administered subcutaneously (under the skin) in adult patients with newly diagnosed or relapsing giant cell arteritis (GCA). Participants also receive prednisone as an additional study treatment, alongside secukinumab or placebo (inactive substance). Secukinumab has been approved by the U.S. Food and Drug Administration (FDA) for various conditions, but its use in this study is investigational. Secukinumab is a monoclonal antibody, which is a type of protein that binds to unique proteins that the body produces. Secukinumab reduces the activity of a “messenger” protein in the body called interleukin-17A (IL-17A). Researchers believe that IL-17A is involved in the GCA disease process and may be partly responsible for inflammation. A product that inhibits IL-17A may therefore help to relieve the negative effects of the disease and improve symptoms.


Inclusion Criteria

  • Signed informed consent must be obtained prior to participation in the study.
  • Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Male or non-pregnant, non-lactating female patients at least 50 years of age.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A randomized, parallel-group, double-blind, placebo controlled, multicenter phase 3 trial to investigate the efficacy and safety of secukinumab 300 mg administered subcutaneously in patients with giant cell arteritis .

Details
Disease Type/Condition

Other

Principal Investigator

Forbess, Lindsy

Age Group

Adult

Phase

III

IRB Number

STUDY00001795

ClinicalTrials.gov ID

NCT04930094

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Forbess, Lindsy

Age Group

Adult

Phase

III

IRB Number

CAIN457R12301

ClinicalTrials.gov ID

NCT04930094

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?