A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria

In brief

The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.

Key facts

Study ID

NCT04159701

Run by

Eli Lilly and Company

People needed

52

Starts

2019-11-15

Expected to finish

2021-02-24

Last updated by the study team

2022-03-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must agree to use appropriate birth control throughout the study
• Must have a diagnosis of CSU for at least 6 months
• Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines
• Must agree to take an anti-histamine every day during the trial
• Must be willing to enter information about symptoms in an electronic diary twice a day

You may not qualify if…

• Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling beneath the skin)
• Must not have a current or recent active infection requiring antibiotics
• Must not have a history of anaphylaxis (severe, life threatening allergic reaction)
• Must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.)
• Must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for CSU

Where it is running

• Kern Research, Inc — Bakersfield, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• California Allergy and Asthma Medical Group + Research Center — Los Angeles, California, United States
• Allergy & Asthma Consultants — Redwood City, California, United States
• Florida Center for Allergy & Asthma Research Landman — Aventura, Florida, United States
• Florida Center for Allergy & Asthma Research Rodicio — Miami, Florida, United States
• Miami Dermatology and Laser Research — Miami, Florida, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• University of South Florida Asthma, Allergy and Immunology — Tampa, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Allergy & Asthma Specialists, P.S.C. — Owensboro, Kentucky, United States
• Johns Hopkins Asthma and Allergy Center — Baltimore, Maryland, United States
• Signature Allergy & Immunology — St Louis, Missouri, United States
• Optimed Research, LTD — Columbus, Ohio, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Northwest Research Center — Portland, Oregon, United States
• Medizinische Hochschule Hanover — Hanover, Lower Saxony, Germany
• Universitätsklinikum Münster — Münster, North Rhine-Westphalia, Germany
• Universitatsmedizin der Johannes Gutenberg-Universitat Mainz — Mainz, Rhineland-Palatinate, Germany
• Charité Campus Virchow-Klinikum — Berlin, Germany
• Rothhaar Studien GmbH — Berlin, Germany
• Diamond Clinic — Krakow, Lesser Poland Voivodeship, Poland
• Centrum Medyczne Evimed — Warsaw, Masovian Voivodeship, Poland

Full record on ClinicalTrials.gov

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