Clinical Trials Logo
  1. Home
  2. Chronic Urticaria
  3. NCT04976192

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

Chronic Urticaria Clinical Trial

Official title:
Study to Evaluate the Efficacy, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to XOLAIR (Omalizumab) in Patients With Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine (H1) Treatment.

Clinical Trial 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.

Clinical Trial Description

This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TEV-45779 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks. At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of TEV-45779 300 mg, XOLAIR 300 mg, TEV-45779 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of TEV-45779 (transition period) at the same dose level as prior to randomization. All patients in the TEV-45779 groups will continue to receive TEV-45779 at the same dose levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04976192
Study type Interventional
Source Teva Pharmaceuticals USA
Contact
Status Completed
Phase Phase 3
Start date August 30, 2021
Completion date April 5, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02435238 - AWARE - Chronic Urticaria N/A
Not yet recruiting NCT05513079 - Positive Psychotherapy-Based Counseling (PPT) N/A
Terminated NCT02047136 - Dietary Treatment for Chronic Urticaria N/A
Completed NCT01803763 - Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients Phase 2/Phase 3
Terminated NCT01170949 - Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria Phase 2
Completed NCT00598611 - Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU) Phase 3
Completed NCT01610128 - Development of an Urticaria Control Test N/A
Completed NCT02285049 - Cross-Cultural of the Validity, Reliability and Interpretability of Thai-version of Urticaria Control Test N/A
Completed NCT02285023 - The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire
Completed NCT01715740 - Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria Phase 3
Completed NCT01960283 - Methotrexate in the Treatment of Chronic Idiopathic Urticaria Phase 3
Completed NCT00481676 - Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria Phase 2
Completed NCT01713725 - Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria Phase 2
Completed NCT01250652 - Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses Phase 4
Completed NCT01111136 - Stress Intervention for Chronic Urticaria N/A
Recruiting NCT01425593 - T Cell Function in Chronic Idiopathic Urticaria N/A
Completed NCT00628108 - Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months Phase 3
Completed NCT00619801 - Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin Phase 3
Completed NCT00737451 - Association of Thyroid Autoimmunity and Chronic Urticaria N/A
Completed NCT01284426 - Natural History of Chronic Urticaria N/A