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

NCT04976192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2025-10-07

Study results available
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Summary

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.

Conditions

  • Chronic Urticaria

Interventions

COMBINATION_PRODUCT

TEV-45779

TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe

COMBINATION_PRODUCT

XOLAIR® Injection

XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.

Sponsors & Collaborators

  • Teva Pharmaceuticals Development, Inc.

    collaborator UNKNOWN

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Pharmaceuticals Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2024-04-05
Completion
2024-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976192 on ClinicalTrials.gov