Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Completed · Phase 3

Conditions studied: Chronic Urticaria

In brief

The purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.

Key facts

Study ID

NCT04976192

Run by

Teva Pharmaceuticals USA

People needed

608

Starts

2021-08-30

Expected to finish

2024-04-05

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CIU refractory to H1 antihistamines for ≥3 months

You may not qualify if…

• Chronic urticaria with clearly defined underlying etiology
• Other skin disease associated with itch
• Evidence of parasitic infection on stool evaluation for ova and parasites
• History of anaphylactic shock
• Hypersensitivity to omalizumab or any component of the formulation
• Required background therapy with other than protocol-defined antihistamines
• Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study

Where it is running

• 10008 — Bakersfield, California, United States
• Site 10001 — Clearwater, Florida, United States
• 10012 — Coral Gables, Florida, United States
• 10006 — Kissimmee, Florida, United States
• 10014 — Maitland, Florida, United States
• 10005 — Miami, Florida, United States
• 10009 — Tampa, Florida, United States
• 10007 — Troy, Michigan, United States
• 10004 — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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